| 1 |
NCT03786614 |
Not yet recruiting |
Antidepressant Discontinuation in Treatment Resistant Depression |
- Treatment Resistant Depression
|
- Other: Discontinuation of serotonergic antidepressants
- Other: Continuation of serotonergic medications
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Comparing the difference of response as measured by the Montgomery-Åsberg Depression Rating Scale [MADRS] between both arms.
- Comparing the difference of response as measured by the Montgomery-Åsberg Depression Rating Scale [MADRS] between subjects with low expressing alleles and high expressing alleles of the serotonin gene transporter.
- Evaluating changes in levels of anxiety as measured by the Hamilton Anxiety Rating Scale [HAM-A] between both arms.
- Evaluating the difference of response as measured by the Columbia Suicide Severity Rating Scale [C-SSRS] between both arms.
|
30 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03786614 |
TRD2018 |
|
February 2019 |
August 2019 |
September 2019 |
December 25, 2018 |
December 25, 2018 |
|
- University of Louisville, Department of Psychiatry and Behavioral Sciences
Louisville, Kentucky, United States
|
|
| 2 |
NCT02700009 |
Recruiting |
Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care |
|
- Behavioral: Computer-assisted CBT (CCBT)
- Other: Treatment as Usual (TAU)
|
Interventional
|
Not Applicable |
- University of Louisville
- University of Denver
- University of York
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Patient Health Questionnaire - 9
- Automatic Thoughts Questionnaire
- Quality of Life Enjoyment and Satisfaction Questionnaire
- (and 4 more...)
|
240 |
All |
18 Years and older (Adult, Older Adult) |
NCT02700009 |
R18HS024047 |
|
May 2016 |
December 2019 |
December 2019 |
March 7, 2016 |
March 2, 2018 |
|
- University of Louisville, School of Medicine
Louisville, Kentucky, United States
|
|
| 3 |
NCT00056485 |
Completed |
Treatment of Depression in Nursing Homes |
|
- Behavioral: Pleasant Events-Based Behavioral Intervention
|
Interventional
|
Not Applicable |
- University of Louisville
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
|
25 |
All |
60 Years and older (Adult, Older Adult) |
NCT00056485 |
R21MH063073 |
|
April 2002 |
August 2006 |
August 2006 |
March 17, 2003 |
April 13, 2017 |
|
- University of Louisville
Louisville, Kentucky, United States
|
|
| 4 |
NCT00536406 |
Completed |
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents |
|
- Behavioral: BE-ACTIV
- Behavioral: Treatment as usual (TAU)
|
Interventional
|
Not Applicable |
- University of Louisville
- National Institute of Mental Health (NIMH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
- Functioning as assessed by the Dartmouth COOP Scales for Social Functioning
- Staff attention
- (and 4 more...)
|
20 |
All |
Child, Adult, Older Adult |
NCT00536406 |
R01MH074865
DATR A4-GPS |
BE-ACTIV |
August 2007 |
July 2013 |
November 2013 |
September 27, 2007 |
April 13, 2017 |
|
- University of Louisville
Louisville, Kentucky, United States
|
|
| 5 |
NCT00404365 |
Completed |
Depression Screening in Patients With Lung Cancer |
|
- Other: counseling intervention
- Other: screening questionnaire administration
- Other: study of socioeconomic and demographic variables
- Procedure: psychosocial assessment and care
|
Interventional
|
Not Applicable |
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
- Lucille P. Markey Cancer Center at University of Kentucky
- Vanderbilt University
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
|
- Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment
- Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale
- Overall patient experience as measured by Patient Experience Questionnaire
- Psychological and demographic subsets of patients
|
241 |
All |
18 Years and older (Adult, Older Adult) |
NCT00404365 |
Mskcc 06-038
R01CA115349
P30CA008748
MSKCC-06038 |
|
April 2006 |
April 2012 |
April 2012 |
November 28, 2006 |
May 1, 2013 |
|
- Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States - Memorial Sloan-Kettering Cancer Center
New York, New York, United States
|
|
| 6 |
NCT00127374 |
Withdrawn |
Mood and Behavior Changes Among Overweight Adolescent Females |
|
- Behavioral: Dietary and physical activity modifications
|
Observational
|
|
|
Other |
|
- Decreased body mass index; increased physical activity
- Improved self-esteem; improved depression scale score; decreased risk-taking behavior
|
0 |
Female |
10 Years to 14 Years (Child) |
NCT00127374 |
04-0541-F3R |
|
January 2005 |
September 2006 |
September 2006 |
August 5, 2005 |
November 8, 2016 |
|
- University of Kentucky
Lexington, Kentucky, United States
|
|
| 7 |
NCT00518258 |
Completed |
Neuroimaging Studies of Depression in Parkinson's Disease |
|
|
Observational
|
|
- Lee Blonder
- National Institute of Mental Health (NIMH)
- National Institute of Neurological Disorders and Stroke (NINDS)
- University of Kentucky
|
Other / NIH |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
120 |
All |
40 Years to 85 Years (Adult, Older Adult) |
NCT00518258 |
R01-MH78228-2 |
|
July 2006 |
December 2011 |
December 2011 |
August 20, 2007 |
May 17, 2013 |
|
- University of Kentucky
Lexington, Kentucky, United States
|
|
| 8 |
NCT01884246 |
Completed |
Improving Heart Health in Appalachia |
- Obesity
- Hypertension
- Hyperlipidemia
- Depression
|
- Behavioral: Self-care CVD risk reduction
- Other: Referral to primary care provider for CVD risk management
|
Interventional
|
Not Applicable |
- Debra Moser
- University of Kentucky Center for Excellence in Rural Health-Hazard
- University of Kentucky
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- cardiovascular risk factor selected by patient
- all CVD risk factors of each patient
|
330 |
All |
21 Years and older (Adult, Older Adult) |
NCT01884246 |
PCORI 3048110484 |
HeartHealth |
August 1, 2013 |
December 31, 2016 |
December 31, 2016 |
June 21, 2013 |
March 10, 2017 |
|
- University of Kentucky
Lexington, Kentucky, United States
|
|
| 9 |
NCT02431806 |
Recruiting |
Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Placebo
- Drug: Levomilnacipran ER
- Drug: Fluoxetine
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Children's Depression Rating Scale-Revised (CDRS-R) total score
- Change in Clinical Global Impression-Severity (CGI-S) scale
|
660 |
All |
12 Years to 17 Years (Child) |
NCT02431806 |
LVM-MD-11 |
|
June 23, 2015 |
December 20, 2019 |
December 20, 2019 |
May 1, 2015 |
January 24, 2019 |
|
- Harmonex, Inc
Dothan, Alabama, United States - Noesis Pharma
Phoenix, Arizona, United States - University of Arizona Department of Psychiatry
Tucson, Arizona, United States - (and 88 more...)
|
|
| 10 |
NCT01436175 |
Terminated
Has Results |
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study |
- Major Depressive Disorder
|
- Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Columbia-Suicide Severity Rating Scale (C-SSRS)
- Change From Baseline in Systolic Blood Pressure at Week 52
- Change From Baseline in Diastolic Blood Pressure at Week 52
- (and 19 more...)
|
1570 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01436175 |
SPD489-329
2011-003019-47 |
|
February 2012 |
February 2014 |
February 2014 |
September 19, 2011 |
February 23, 2015 |
February 23, 2015 |
- Birmingham Research Group
Birmingham, Alabama, United States - ResearchOne, Inc.
Scottsdale, Arizona, United States - Arkansas Psychiatric Clinical Research Trials, P.A.
Little Rock, Arkansas, United States - (and 209 more...)
|
|
| 11 |
NCT01967394 |
Completed |
Social Media, Teen Moms and PPD |
|
- Other: Use of internet based social marketing intervention
- Other: No use of social media
|
Interventional
|
Not Applicable |
- University of Louisville
- National Institute of Nursing Research (NINR)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Outcomes Assessor)
|
- Effectiveness of Social Marketing Intervention
- Number of teens seeking depression treatment
|
287 |
Female |
13 Years to 21 Years (Child, Adult) |
NCT01967394 |
1R15NR013563-01A1
R15NR013563 |
|
June 2013 |
December 2015 |
December 2015 |
October 22, 2013 |
December 29, 2015 |
|
- Three Rivers
Carrollton, Kentucky, United States - Hands Program of Kenton County (Young Families of Children, Inc)
Covington, Kentucky, United States - Lincoln Trail Health Department
Elizabethtown, Kentucky, United States - (and 5 more...)
|
|
| 12 |
NCT02141399 |
Completed
Has Results |
A Long-Term Safety Study of ALKS 5461 |
- Major Depressive Disorder
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Adverse Events (AEs)
|
1485 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02141399 |
ALK5461-208 |
|
May 2014 |
November 20, 2017 |
November 20, 2017 |
May 19, 2014 |
December 14, 2018 |
December 14, 2018 |
- Alkermes Investigational Site
Birmingham, Alabama, United States - Alkermes Investigational Site
Birmingham, Alabama, United States - Alkermes Investigational Site
Tucson, Arizona, United States - (and 155 more...)
|
|
| 13 |
NCT03665038 |
Recruiting |
A Study to Assess the Safety and Efficacy of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression |
|
- Drug: Brexanolone
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Evaluate the effects of brexanolone on depressive symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D) when administered to adolescent female subjects diagnosed with PPD.
- Assess the effects of brexanolone on the Clinical Global Impression (CGI)-Improvement score.
- Evaluate the safety and tolerability of brexanolone based on adverse events and serious adverse events.
- (and 8 more...)
|
80 |
Female |
15 Years to 17 Years (Child) |
NCT03665038 |
547-PPD-304 |
|
May 17, 2018 |
June 2020 |
September 2020 |
September 11, 2018 |
October 31, 2018 |
|
- Sage Investigational Site
Chandler, Arizona, United States - Sage Investigational Site
Rogers, Arkansas, United States - Sage Investigational Site
Pensacola, Florida, United States - (and 9 more...)
|
|
| 14 |
NCT02942004 |
Completed |
A Study to Evaluate SAGE-547 in Patients With Severe Postpartum Depression |
- Severe Postpartum Depression
|
- Drug: SAGE-547
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Effect of SAGE-547 on depressive symptoms in subjects with severe postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score
- Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters
- Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score
|
138 |
Female |
18 Years to 45 Years (Adult) |
NCT02942004 |
547-PPD-202 B |
|
July 2016 |
September 24, 2017 |
October 19, 2017 |
October 21, 2016 |
September 10, 2018 |
|
- Sage Investigational Site
Chandler, Arizona, United States - Sage Investigational Site
Little Rock, Arkansas, United States - Sage Investigational Site
Little Rock, Arkansas, United States - (and 46 more...)
|
|
| 15 |
NCT02942017 |
Completed |
A Study to Evaluate SAGE-547 in Patients With Moderate Postpartum Depression |
- Moderate Postpartum Depression
|
- Drug: SAGE-547
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Effect of SAGE-547 on depressive symptoms in subjects with moderate postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score
- Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters
- Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score
|
108 |
Female |
18 Years to 45 Years (Adult) |
NCT02942017 |
547-PPD-202 C |
|
July 2016 |
September 17, 2017 |
October 11, 2017 |
October 21, 2016 |
September 10, 2018 |
|
- Sage Investigational Site
Chandler, Arizona, United States - Sage Investigational Site
Little Rock, Arkansas, United States - Sage Investigational Site
Little Rock, Arkansas, United States - (and 46 more...)
|
|
| 16 |
NCT01275742 |
Completed |
Helping Others Toward Positive Emotions in People With Heart Failure |
|
- Behavioral: Brief Cognitive Therapy Intervention
|
Interventional
|
Not Applicable |
- Rebecca L. Dekker, PhD, RN, APRN
- National Institute of Nursing Research (NINR)
- University of Kentucky
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cardiac event-free survival
- Depressive symptoms
- Health-related quality of life
- (and 3 more...)
|
180 |
All |
21 Years and older (Adult, Older Adult) |
NCT01275742 |
5P20NR010679-04
5P20NR010679 |
HOPE-HF |
January 2011 |
August 2016 |
August 2016 |
January 12, 2011 |
August 11, 2017 |
|
- University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
|
|
| 17 |
NCT00788944 |
Completed |
Determine The Percentage Of Depressed Outpatients Who Do Not Effectively Metabolize Extended-release Venlafaxine HCl |
|
|
Interventional
|
Phase 4 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- 0-desmethyl venlafaxine/venlafaxine ratio (levels of the drug in the blood)
- Determine the percentage of patients treated with extended-release venlafaxine HCl who are genotypic Poor Metabolizers.
|
971 |
All |
18 Years and older (Adult, Older Adult) |
NCT00788944 |
0600B1-4433
B2411001 |
|
October 2008 |
July 2009 |
July 2009 |
November 11, 2008 |
January 7, 2011 |
|
- Pfizer Investigational Site
Birmingham, Alabama, United States - Pfizer Investigational Site
Tuscon, Arizona, United States - Pfizer Investigational Site
Little Rock, Arkansas, United States - (and 50 more...)
|
|
| 18 |
NCT02473289 |
Completed |
An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder |
- Depressive Disorder, Major
|
- Drug: Sirukumab 50 mg
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 12
- Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Week 12
- (and 6 more...)
|
193 |
All |
21 Years to 64 Years (Adult) |
NCT02473289 |
CR107171
CNTO136MDD2001
2014-005206-37 |
|
July 23, 2015 |
May 22, 2018 |
May 22, 2018 |
June 16, 2015 |
September 21, 2018 |
|
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Bellflower, California, United States
- (and 43 more...)
|
|
| 19 |
NCT01114477 |
Completed |
NeuroStar TMS Therapy System: Utilization and Outcomes |
- Major Depressive Disorder
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)
- Total score for the Clinical Global Impressions-Severity (CGI-S)
- Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)
- (and 3 more...)
|
307 |
All |
Child, Adult, Older Adult |
NCT01114477 |
19-50001-000 |
|
March 2010 |
September 2012 |
September 2012 |
May 3, 2010 |
November 13, 2015 |
|
- Lee Ann Kelley, M.D., PC
Phoenix, Arizona, United States - Bay Psychiatric Associates
Berkeley, California, United States - TMS Center of Beverly Hills
Beverly Hills, California, United States - (and 41 more...)
|
|
| 20 |
NCT01273376 |
Completed |
Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder |
- Major Depressive Disorder
|
|
Interventional
|
Phase 2 |
- Rexahn Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7
|
314 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01273376 |
2010MDD01 |
MDD |
December 2010 |
September 2011 |
October 2011 |
January 10, 2011 |
November 19, 2013 |
|
- Rexahn Investigative Site
Cerritos, California, United States - Rexahn Investigative Site
Escondido, California, United States - Rexahn Investigative Site
Los Angeles, California, United States - (and 41 more...)
|
|
| 21 |
NCT02158546 |
Completed |
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study |
- Major Depressive Disorder
|
- Drug: ALKS 5461
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score
- Response during randomized treatment
- Remission during randomized treatment
- Safety and tolerability will be assessed by number and percentage of subjects with adverse events (AEs)
|
447 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02158546 |
ALK5461-206 |
|
May 2014 |
December 2015 |
December 2015 |
June 9, 2014 |
March 2, 2016 |
|
- Alkermes Investigational Site
Little Rock, Arkansas, United States - Alkermes Investigational Site
Bellflower, California, United States - Alkermes Investigational Site
Beverly Hills, California, United States - (and 55 more...)
|
|
| 22 |
NCT02158533 |
Completed |
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study |
- Major Depressive Disorder
|
- Drug: High Dose ALKS 5461
- Drug: Low Dose ALKS 5461
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score
- Response during randomized treatment
- Remission during randomized treatment
- Safety and tolerability will be assessed by incidence of adverse events (AEs)
|
385 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02158533 |
ALK5461-205 |
|
May 2014 |
December 2015 |
December 2015 |
June 9, 2014 |
March 2, 2016 |
|
- Alkermes Investigational Site
Birmingham, Alabama, United States - Alkermes Investigational Site
Tucson, Arizona, United States - Alkermes Investigational Site
Carson, California, United States - (and 46 more...)
|
|
| 23 |
NCT00278941 |
Completed |
Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Quetiapine Fumarate Sustained Release
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)
- Evaluate quetiapine SR compared to placebo on health related quality of life.
|
3000 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00278941 |
D1448C00005
Amethyst |
AMETHYST |
December 2005 |
|
August 2007 |
January 19, 2006 |
March 25, 2009 |
|
- Research Site
Birmingham, Alabama, United States - Research Site
Tuscaloosa, Alabama, United States - Research Site
Mesa, Arizona, United States - (and 165 more...)
|
|
| 24 |
NCT00672620 |
Completed
Has Results |
Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Vortioxetine
- Drug: Duloxetine
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8
- Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
- Percentage of Responders in HAM-D 24 Total Score by Study Visit
- (and 9 more...)
|
611 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00672620 |
LuAA21004_304
U1111-1114-3497 |
|
April 2008 |
November 2008 |
December 2008 |
May 6, 2008 |
December 18, 2013 |
December 18, 2013 |
- Beverly Hills, California, United States
- Irvine,, California, United States
- Santa Ana, California, United States
- (and 35 more...)
|
|
| 25 |
NCT00326144 |
Completed |
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders |
- Major Depressive Disorder
|
- Drug: Quetiapine fumarate
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score
- To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo
- To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo
|
310 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00326144 |
D1448C00003
OPAL |
OPAL |
April 2006 |
|
May 2007 |
May 16, 2006 |
March 25, 2009 |
|
- Research Site
Phoenix, Arizona, United States - Research Site
Little Rock, Arkansas, United States - Research Site
Anaheim, California, United States - (and 31 more...)
|
|
| 26 |
NCT00707980 |
Completed
Has Results |
Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder |
- Major Depressive Disorder
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Physical Examination Findings
- Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
- Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
- (and 9 more...)
|
836 |
All |
18 Years to 76 Years (Adult, Older Adult) |
NCT00707980 |
LuAA21004_301
2008-001581-91
U1111-1113-9564 |
|
June 2008 |
July 2010 |
August 2010 |
July 2, 2008 |
December 13, 2013 |
December 13, 2013 |
- Beverly Hills, California, United States
- Irvine, California, United States
- Santa Ana, California, United States
- (and 89 more...)
|
|
| 27 |
NCT01153347 |
Completed
Has Results |
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder |
- Major Depressive Disorder
- Depression
|
- Drug: TC-5214
- Drug: Placebo
|
Interventional
|
Phase 3 |
- AstraZeneca
- Targacept Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.
- Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)
- Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)
- (and 20 more...)
|
2409 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01153347 |
D4130C00004 |
|
June 2010 |
January 2012 |
January 2012 |
June 30, 2010 |
April 11, 2014 |
November 20, 2012 |
- Research Site
Birmingham, Alabama, United States - Research Site
Tucson, Arizona, United States - Research Site
Conway, Arkansas, United States - (and 96 more...)
|
|
| 28 |
NCT01157078 |
Completed
Has Results |
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD) |
- Major Depressive Disorder
- Depression
|
- Drug: TC-5214
- Drug: Placebo
|
Interventional
|
Phase 3 |
- AstraZeneca
- Targacept Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.
- Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)
- Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)
- (and 19 more...)
|
319 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01157078 |
D4130C00002 |
|
June 2010 |
November 2011 |
November 2011 |
July 5, 2010 |
April 11, 2014 |
November 20, 2012 |
- Research Site
Tuscaloosa, Alabama, United States - Research Site
Tucson, Arizona, United States - Research Site
Little Rock, Arkansas, United States - (and 48 more...)
|
|
| 29 |
NCT00057213 |
Completed |
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder |
- Depressive Disorder, Major
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment
- Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy, fatigue and pain;incidence of adverse events over course of study;
|
367 |
All |
18 Years to 64 Years (Adult) |
NCT00057213 |
OHB20002 |
|
March 2003 |
April 2007 |
April 2007 |
March 28, 2003 |
April 16, 2015 |
|
- GSK Investigational Site
Peoria, Arizona, United States - GSK Investigational Site
Scottsdale, Arizona, United States - GSK Investigational Site
Garden Grove, California, United States - (and 18 more...)
|
|
| 30 |
NCT01435759 |
Completed
Has Results |
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
- Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
- Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
- (and 2 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)
- Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
- Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
- Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16
|
1197 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01435759 |
SPD489-209
2011-003615-28 |
|
May 31, 2011 |
January 17, 2014 |
January 17, 2014 |
September 19, 2011 |
January 8, 2019 |
February 19, 2015 |
- Arkansas Psychiatric Clinic Clinical Research Trials
Little Rock, Arkansas, United States - South Coast Clinical Trials
Anaheim, California, United States - Catalina Research Institute, LLC
Chino, California, United States - (and 79 more...)
|
|
| 31 |
NCT01436149 |
Completed
Has Results |
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: SPD489 (Lisdexamfetamine dimesylate )
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks
- Percentage of Participants Achieving a 25% Response on the MADRS
- (and 9 more...)
|
1262 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01436149 |
SPD489-322
2011-003018-17 |
|
October 27, 2011 |
December 23, 2013 |
December 23, 2013 |
September 19, 2011 |
January 4, 2019 |
November 19, 2014 |
- Birmingham Research Group
Birmingham, Alabama, United States - AV Institue, Inc.
Carson, California, United States - University of California, Irvine Child Development Center
Irvine, California, United States - (and 82 more...)
|
|
| 32 |
NCT01070329 |
Completed
Has Results |
A Study in Depression and Associated Painful Physical Symptoms |
- Major Depressive Disorder
|
- Drug: Duloxetine
- Drug: Placebo
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
- Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
- Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8
- (and 7 more...)
|
527 |
All |
18 Years and older (Adult, Older Adult) |
NCT01070329 |
13630
F1J-US-HMGU |
|
March 2010 |
March 2011 |
March 2011 |
February 18, 2010 |
February 13, 2012 |
February 13, 2012 |
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sherman Oaks, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cromwell, Connecticut, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Lauderdale, Florida, United States - (and 31 more...)
|
|
| 33 |
NCT03039192 |
Completed |
A Study of the Efficacy and Safety of Intranasal Esketamine in the Rapid Reduction of Symptoms of Major Depressive Disorder, in Adult at Imminent Risk for Suicide |
- Depressive Disorder, Major
|
- Drug: Esketamine
- Other: Placebo
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in MADRS Total Score at 24 Hours Post First Dose
- Change From Baseline in CGI-SS-R at 24 Hours Post First Dose
|
226 |
All |
18 Years to 64 Years (Adult) |
NCT03039192 |
CR108284
2016-003990-17
54135419SUI3001 |
Aspire I |
June 9, 2017 |
December 18, 2018 |
December 18, 2018 |
February 1, 2017 |
February 11, 2019 |
|
- UAB Department of Psychiatry and Behavioral Neurobiology
Birmingham, Alabama, United States - Metropolitan Neuro Behavioral Institute
Chandler, Arizona, United States - Collaborative NeuroScience Network
Garden Grove, California, United States - (and 53 more...)
|
|
| 34 |
NCT01842542 |
Completed |
Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset |
|
- Device: NeuroStar Transcranial Magnetic Stimulation (TMS)
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset
- Determine the safety of NeuroStar TMS Therapy.
|
25 |
Female |
18 Years to 50 Years (Adult) |
NCT01842542 |
44-03014-000 |
|
December 2013 |
July 2015 |
August 2015 |
April 29, 2013 |
October 27, 2015 |
|
- Hartford Hospital Institute of Living
Hartford, Connecticut, United States - UF Health Adult Psychiatry - Springhill
Gainesville, Florida, United States - Harmonex Neuroscience and Research of Pensacola
Pensacola, Florida, United States - (and 5 more...)
|
|
| 35 |
NCT00095745 |
Completed |
A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Antidepressant + Aripiprazole
|
Interventional
|
Phase 3 |
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Otsuka America Pharmaceutical
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
1002 |
All |
18 Years and older (Adult, Older Adult) |
NCT00095745 |
CN138-164 |
|
September 2004 |
November 2007 |
November 2007 |
November 9, 2004 |
November 8, 2013 |
|
- Local Institution
Mesa, Arizona, United States - Local Institution
Peoria, Arizona, United States - Local Institution
Beverly Hills, California, United States - (and 55 more...)
|
|
| 36 |
NCT00095134 |
Completed |
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy |
- Major Depressive Disorder
|
|
Interventional
|
Phase 3 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Janssen, LP
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Difference in therapeutic effect of risperidone and placebo as measured by change in depression rating scale (HAM-D) at end of week 4 of the double-blind phase.
- Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).
|
630 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00095134 |
CR004726 |
|
October 2004 |
|
November 2005 |
November 1, 2004 |
December 6, 2011 |
|
- Innovative Clinical Trials, LLC
Birmingham, Alabama, United States - Greystone Medical Research
Birmingham, Alabama, United States - Scottsdale Family Health
Scottsdale, Arizona, United States - (and 67 more...)
|
|
| 37 |
NCT00531947 |
Completed
Has Results |
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression |
- Major Depressive Disorder
|
- Drug: Selegiline Transdermal System
- Drug: Placebo
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
- CGI-S - Week 12 (mITT w/LOCF Population)
- CGI-C - Week 12 (mITT w/LOCF Population)
- (and 16 more...)
|
308 |
All |
12 Years to 17 Years (Child) |
NCT00531947 |
S9303-P0605 |
|
July 2007 |
October 2010 |
October 2010 |
September 19, 2007 |
January 15, 2014 |
June 26, 2013 |
- Dr. Nelson Handal
Dothan, Alabama, United States - Dr. Mohammed Bari
National City, California, United States - Dr. Michael McManus
SanDiego, California, United States - (and 17 more...)
|
|
| 38 |
NCT00518986 |
Completed
Has Results |
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression |
- Sleep Disorders
- Obstructive Sleep Apnea
- Major Depressive Disorder
- Dysthymic Disorder
|
- Drug: armodafinil
- Drug: placebo
|
Interventional
|
Phase 4 |
- Cephalon
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)
- Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)
- Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)
- (and 57 more...)
|
249 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00518986 |
C10953/4024/ES/US |
|
October 2007 |
March 2009 |
March 2009 |
August 21, 2007 |
July 19, 2013 |
March 29, 2011 |
- Jasper Summit Research, LLC
Jasper, Alabama, United States - Pulmonary Associates, P.A.
Phoenix, Arizona, United States - Psypharma Clinical Research
Phoenix, Arizona, United States - (and 59 more...)
|
|
| 39 |
NCT01152554 |
Completed
Has Results |
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder |
- Major Depressive Disorder
- MDD
- Depression
|
- Drug: TC-5214
- Drug: Placebo
|
Interventional
|
Phase 3 |
- AstraZeneca
- Targacept Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Frequency of Patients Experiencing at Least One Adverse Event (AE)
- Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
- Frequency of Patients Experiencing Serious Adverse Events (SAEs)
- (and 6 more...)
|
813 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01152554 |
D4130C00007 |
|
June 2010 |
February 2012 |
February 2012 |
June 29, 2010 |
April 11, 2014 |
October 29, 2012 |
- Research Site
Birmingham, Alabama, United States - Research Site
Tuscaloosa, Alabama, United States - Research Site
Tucson, Arizona, United States - (and 91 more...)
|
|
| 40 |
NCT00285766 |
Completed |
Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression |
|
- Drug: Selegiline Transdermal System
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
300 |
All |
65 Years and older (Older Adult) |
NCT00285766 |
S9303-P0204 |
|
August 2002 |
|
July 2005 |
February 2, 2006 |
April 22, 2008 |
|
- Mohammed Bari, M.D.
Chula Vista, California, United States - Charles Meredith, M.D.
San Diego, California, United States - Daniel Zimbroff, M.D.
Upland, California, United States - (and 12 more...)
|
|
| 41 |
NCT00245973 |
Completed |
Study Evaluating Bifeprunox in Bipolar Depression |
|
|
Interventional
|
Phase 3 |
- Wyeth is now a wholly owned subsidiary of Pfizer
- Solvay Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Secondary measurement scales will be used:
- Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
- Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
- (and 4 more...)
|
380 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00245973 |
3168A2-307 |
|
June 2005 |
|
October 2007 |
October 28, 2005 |
December 5, 2007 |
|
- Birmingham, Alabama, United States
- Beverly Hills, California, United States
- National City, California, United States
- (and 37 more...)
|
|
| 42 |
NCT02978326 |
Completed |
A Study to Evaluate SAGE-217 in Subjects With Severe Postpartum Depression |
|
- Drug: SAGE-217
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Effect of SAGE-217 on depressive symptoms in subjects with severe postpartum depression compared to placebo as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score
- Safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, and electrocardiogram (ECG) parameters
- Safety and tolerability of SAGE-217 compared to placebo as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
|
153 |
Female |
18 Years to 45 Years (Adult) |
NCT02978326 |
217-PPD-201 |
|
December 2016 |
November 15, 2018 |
December 11, 2018 |
November 30, 2016 |
January 14, 2019 |
|
- Sage Investigational Site
Chandler, Arizona, United States - Sage Investigational Site
Little Rock, Arkansas, United States - Sage Investigational Site
Corona, California, United States - (and 35 more...)
|
|
| 43 |
NCT01072630 |
Completed
Has Results |
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder |
|
- Drug: Armodafinil
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Cephalon
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
- Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
- Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
- (and 20 more...)
|
492 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01072630 |
C10953/3072
2009-016634-27 |
|
March 2010 |
November 2012 |
November 2012 |
February 22, 2010 |
April 27, 2016 |
January 26, 2015 |
- Birmingham Psychiatry Pharmaceutical Studies, Inc
Birmingham, Alabama, United States - South Coast Medical Associates/SC Clinical Trials, Inc.
Anaheim, California, United States - Comprehensive NeuroScience
Cerritos, California, United States - (and 89 more...)
|
|
| 44 |
NCT00958568 |
Completed
Has Results |
A Study in Relapse Prevention of Treatment-Resistant Depression |
- Treatment Resistant Depression
|
- Drug: Olanzapine and Fluoxetine combination (OFC)
- Drug: Fluoxetine
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to Relapse by Any Criteria
- Percentage of Participants Who Relapse by Any Criteria
- Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score
- (and 35 more...)
|
892 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00958568 |
12115
H6P-MC-HDAY
CTRI/2009/091/000654 |
|
August 2009 |
March 2012 |
March 2012 |
August 13, 2009 |
April 1, 2014 |
April 1, 2014 |
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pasadena, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sherman Oaks, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wildomar, California, United States - (and 63 more...)
|
|
| 45 |
NCT01360632 |
Completed
Has Results |
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial) |
- Depressive Disorder
- Depression
- Depressive Disorder, Major
- (and 2 more...)
|
- Drug: OPC-34712 + ADT
- Drug: Placebo + ADT
|
Interventional
|
Phase 3 |
- Otsuka Pharmaceutical Development & Commercialization, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set
- Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol
- Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set
- (and 21 more...)
|
1539 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01360632 |
331-10-227 |
Polaris |
June 2011 |
August 2013 |
September 2013 |
May 25, 2011 |
January 1, 2016 |
January 1, 2016 |
- Research Site
Birmingham, Alabama, United States - Research Site
Costa Mesa, California, United States - Research Site
Glendale, California, United States - (and 68 more...)
|
|
| 46 |
NCT02586688 |
Active, not recruiting |
Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents |
- Major Depressive Disorder
|
- Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
- Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
- Device: Open Label Active NeuroStar® TMS
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value.
|
100 |
All |
12 Years to 21 Years (Child, Adult) |
NCT02586688 |
44-02219-000 |
|
October 2015 |
January 2018 |
December 2018 |
October 26, 2015 |
February 2, 2018 |
|
- Dothan Behavioral Medicine
Dothan, Alabama, United States - UCLA
Los Angeles, California, United States - Stanford University
Palo Alto, California, United States - (and 10 more...)
|
|
| 47 |
NCT01492348 |
Completed |
Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial |
- Posttraumatic Stress Disorder (PTSD)
- Depression
|
- Behavioral: STEPS UP
- Behavioral: OUC
|
Interventional
|
Not Applicable |
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- United States Department of Defense
- RAND
- (and 3 more...)
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Posttraumatic Diagnostic Scale (PDS)
- Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)
- Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)
- (and 4 more...)
|
666 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01492348 |
W81XWH-09-2-0077 |
STEPS UP |
January 2012 |
October 2014 |
February 2016 |
December 14, 2011 |
March 14, 2017 |
|
- Evans Army Community Hospital
Ft. Carson, Colorado, United States - Winn Army Community Hospital
Fort Stewart, Georgia, United States - Blanchfield Army Community Hospital
Fort Campbell, Kentucky, United States - (and 3 more...)
|
|
| 48 |
NCT00134459 |
Completed |
Study Evaluating Bifeprunox in Bipolar Depression |
|
- Drug: Bifeprunox
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Wyeth is now a wholly owned subsidiary of Pfizer
- Solvay Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- The objective of this study is to investigate if 8 weeks of treatment with flexible doses of bifeprunox (20 to 40 mg/day) is superior to treatment with placebo in depressed outpatients with bipolar disorder.
- Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint
|
434 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00134459 |
3168A2-304
B3101016 |
|
June 2005 |
May 2006 |
May 2006 |
August 24, 2005 |
February 15, 2013 |
|
- Birmingham, Alabama, United States
- Beverly Hills, California, United States
- National City, California, United States
- (and 37 more...)
|
|
| 49 |
NCT01432236 |
Completed
Has Results |
A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression |
|
- Drug: Pregabalin
- Drug: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean NRS Pain Score at End of Period.
- Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.
- FIQ Score at End of Period.
- (and 11 more...)
|
197 |
All |
18 Years and older (Adult, Older Adult) |
NCT01432236 |
A0081275
2011-002480-19 |
|
October 2011 |
July 2013 |
July 2013 |
September 12, 2011 |
October 22, 2014 |
October 22, 2014 |
- Genova Clinical Research
Tucson, Arizona, United States - SDS Clinical Trials
Orange, California, United States - Research Across America
Santa Ana, California, United States - (and 34 more...)
|
|
| 50 |
NCT00086190 |
Completed
Has Results |
Study of Antidepressants in Parkinson's Disease |
- Parkinson Disease
- Depression
|
- Drug: paroxetine
- Drug: venlafaxine
- Other: placebo
|
Interventional
|
Phase 3 |
- University of Rochester
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Hamilton Depression Rating Scale (HAM-D) Scores
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)
- Change in Beck Depression Inventory II (BDI-II)
- (and 14 more...)
|
115 |
All |
30 Years and older (Adult, Older Adult) |
NCT00086190 |
R01NS046487 |
SAD-PD |
June 2005 |
November 2009 |
November 2009 |
June 29, 2004 |
January 4, 2013 |
January 4, 2013 |
- University of California San Francisco
San Francisco, California, United States - University of Florida
Gainesville, Florida, United States - University of Miami
Miami, Florida, United States - (and 15 more...)
|
|
| 51 |
NCT01467700 |
Terminated
Has Results |
Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder |
|
- Drug: Ramelteon SL
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6
- Change From Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) Short Form Total Score at Week 6
- Percentage of Participants With MADRS Response at Week 6, With Response Defined as a ≥ 50% Decrease in the MADRS Total Score From Baseline
- (and 6 more...)
|
490 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01467700 |
TAK-375SL_201
U1111-1122-7380 |
|
December 2011 |
March 2015 |
March 2015 |
November 9, 2011 |
May 16, 2016 |
May 16, 2016 |
- Birmingham, Alabama, United States
- Dothan, Alabama, United States
- Muscle Shoals, Alabama, United States
- (and 158 more...)
|
|
| 52 |
NCT02538146 |
Terminated |
Effect of Acetyl-L-carnitine on Chronic Pancreatitis |
|
- Dietary Supplement: acetyl-L-carnitine 1000mg 2X per day for 3 months
|
Interventional
|
Early Phase 1 |
- Karin High
- University of Kentucky
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Pain score
- Well Being
- Generalized anxiety disorder 7-item (GAD-7) Scoring
- (and 2 more...)
|
3 |
All |
20 Years to 90 Years (Adult, Older Adult) |
NCT02538146 |
UKentucky |
|
August 2015 |
October 2016 |
October 2016 |
September 2, 2015 |
March 10, 2017 |
|
- University of Kentucky Center for Clinical and Translational Science
Lexington, Kentucky, United States
|
|
| 53 |
NCT01286233 |
Unknown † |
Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32 |
- Breast Cancer
- Depression
- Fatigue
- Sleep Disorders
|
- Drug: Metformin
- Drug: Placebo
|
Observational
|
|
- NSABP Foundation Inc
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Questionnaire scores from patient reported outcome battery regarding fatigue, stress, sleep, depression, and general quality of life
- Questionnaire scores from patient reported comorbid conditions and behavioral risks
- Biological correlates of fatigue (medical and demographic characteristics of pts.)
- (and 2 more...)
|
394 |
Female |
18 Years to 74 Years (Adult, Older Adult) |
NCT01286233 |
NSABP MA.32.F
NSABP-NCIC-CTG-MA.32.F |
|
July 2011 |
September 2016 |
September 2016 |
January 31, 2011 |
September 9, 2015 |
|
- Kaiser Permanente Medical Center - Anaheim/Orange County
Anaheim, California, United States - Kaiser Permanente - Deer Valley
Antioch, California, United States - Kaiser Permanente Medical Center - Baldwin Park
Baldwin Park, California, United States - (and 253 more...)
|
|
| 54 |
NCT00005850 |
Completed |
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer |
- Anxiety Disorder
- Depression
- Fatigue
- Lung Cancer
|
- Drug: cisplatin
- Drug: fluoxetine
- Drug: gemcitabine hydrochloride
|
Interventional
|
Phase 2 |
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in the MHI-17 global psychological distress subscale
- Overall survival
- Failure-free survival
|
21 |
All |
Child, Adult, Older Adult |
NCT00005850 |
CALGB-119802
U10CA031946
CLB-119802
CDR0000067871 |
|
August 2001 |
September 2003 |
September 2003 |
January 27, 2003 |
July 4, 2016 |
|
- Northeast Alabama Regional Medical Center
Anniston, Alabama, United States - Veterans Affairs Medical Center - San Diego
San Diego, California, United States - Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States - (and 40 more...)
|
|
| 55 |
NCT00046449 |
Completed |
Prevention of Seasonal Affective Disorder |
- Seasonal Affective Disorder (SAD)
|
- Drug: Investigational Seasonal Affective Disorder (SAD) Drug
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
|
All |
18 Years and older (Adult, Older Adult) |
NCT00046449 |
398149 |
|
September 2002 |
June 2003 |
June 2003 |
October 2, 2002 |
June 4, 2015 |
|
- Study Site
Homer, Alaska, United States - Study Site
New Haven, Connecticut, United States - Study Site
Newark, Delaware, United States - (and 51 more...)
|
|
| 56 |
NCT01914393 |
Completed |
Pediatric Open-Label Extension Study |
- Schizophrenia
- Autism
- Bipolar Depression
|
- Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs)
- Change in Laboratory tests
- Change in Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS)
- (and 21 more...)
|
702 |
All |
6 Years to 17 Years (Child) |
NCT01914393 |
D1050302
2013-001694-24 |
|
September 30, 2013 |
October 17, 2018 |
October 17, 2018 |
August 2, 2013 |
December 7, 2018 |
|
- Harmonex Neuroscience Research
Dothan, Alabama, United States - Diligent Clinical Trials, Inc
Downey, California, United States - University of California San Francisco Medical Center
San Francisco, California, United States - (and 85 more...)
|
|
| 57 |
NCT00128934 |
Completed |
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder |
- Menstruation Disturbances
- Premenstrual Syndrome
|
- Drug: levonorgestrel/ethinyl estradiol
|
Interventional
|
Phase 3 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
- Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
|
744 |
Female |
18 Years to 49 Years (Adult) |
NCT00128934 |
0858A4-316 |
|
August 2005 |
|
December 2007 |
August 10, 2005 |
December 27, 2007 |
|
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Jonesboro, Arkansas, United States
- (and 80 more...)
|
|
| 58 |
NCT00081380 |
Completed |
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder |
|
- Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic)
- Drug: lithium (mood stabilizer)
- Drug: divalproex (mood stabilizer)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
- Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event.
|
710 |
All |
18 Years and older (Adult, Older Adult) |
NCT00081380 |
D1447C00127 |
|
March 2004 |
|
September 2006 |
April 19, 2004 |
December 22, 2008 |
|
- Research Site
Birmingham, Alabama, United States - Research Site
Scottsdale, Arizona, United States - Research Site
Little Rock, Arkansas, United States - (and 91 more...)
|
|
| 59 |
NCT02655354 |
Recruiting |
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity |
- Posttraumatic Stress Disorder
- Depression
- Alcohol-Related Disorders
- (and 8 more...)
|
- Behavioral: Motivational Interviewing
- Behavioral: Cognitive Behavioral Therapy Elements
- Behavioral: Care Management
- (and 11 more...)
|
Interventional
|
Not Applicable |
- University of Washington
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from Baseline PTSD Checklist Civilian Over the Course of a Year
- Change from Baseline Patient Health Questionnaire 9 item Depression Scale Over the Course of a Year
- Change from Baseline Alcohol Use Disorders Identification Over the Course of a Year
- (and 7 more...)
|
960 |
All |
18 Years and older (Adult, Older Adult) |
NCT02655354 |
UH3MH106338-02 |
TSOS6 |
October 2015 |
September 2018 |
June 2019 |
January 14, 2016 |
May 20, 2016 |
|
- Honor Health
Scottsdale, Arizona, United States - Cedars Sinai
Beverly Hills, California, United States - U.C. Davis
Sacramento, California, United States - (and 21 more...)
|
|
| 60 |
NCT00163566 |
Unknown † |
Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80 |
- Hypogonadism,
- Late Onset Hypogonadism,
- Low Testosterone
|
- Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gel
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Body Composition
- Change in sexual libido, and overall function and mood
- Normalization of serum androgen levels
|
128 |
Male |
55 Years to 80 Years (Adult, Older Adult) |
NCT00163566 |
03-DHT-01 |
|
October 2004 |
October 2006 |
December 2012 |
September 14, 2005 |
July 12, 2012 |
|
- Radiant Research - Phoenix
Phoenix, Arizona, United States - Harbor UCLA Medical Reserach and Education Institute
Torrance, California, United States - Malcom Randall VA Medical Center
Gainesville, Florida, United States - (and 13 more...)
|
|
| 61 |
NCT00444301 |
Completed |
Pain Assessment, Incidence & Nature in Heart Failure |
|
|
Observational
|
|
- PC-HEART
- Mayday Fund
- National Institute on Aging (NIA)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
349 |
All |
18 Years and older (Adult, Older Adult) |
NCT00444301 |
06-117PCER |
PAIN-HF |
June 2006 |
December 2007 |
December 2007 |
March 7, 2007 |
June 11, 2008 |
|
- San Diego Hospice & Palliative Care
San Diego, California, United States - Washington DC VAMC Heart Failure Clinic
Washington, District of Columbia, United States - Hospice of Palm Beach County
Palm Beach, Florida, United States - (and 11 more...)
|
|
Create an RSS feed from your search for:
Download the search results for: