| 1 |
NCT01179516 |
Completed
Has Results |
Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder |
- Depressive Disorder, Major
|
- Drug: Vortioxetine
- 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 Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
- Percentage of Participants With a MADRS Response at Week 8
- Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8
- (and 3 more...)
|
469 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01179516 |
LuAA21004_317
U1111-1116-3223
SU-06032011-7846 |
|
August 2010 |
May 2012 |
June 2012 |
August 11, 2010 |
December 18, 2013 |
December 18, 2013 |
- Little Rock, Arkansas, United States
- Carson, California, United States
- Cerritos, California, United States
- (and 58 more...)
|
| 2 |
NCT02972632 |
Completed |
Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder |
- Major Depressive Disorder
|
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants who Achieve Goal Attainment Scale (GAS) Score of ≥50 at Week 12
- Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12
- Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12
- (and 5 more...)
|
123 |
All |
18 Years to 65 Years (Adult) |
NCT02972632 |
Vortioxetine-4003
U1111-1185-6902 |
|
December 22, 2016 |
February 6, 2018 |
February 6, 2018 |
November 23, 2016 |
February 13, 2018 |
|
- ATP Clinical Research, Inc.
Costa Mesa, California, United States - ProScience Research Group
Culver City, California, United States - Behavioral Research Specialists, LLC
Glendale, California, United States - (and 22 more...)
|
| 3 |
NCT01255787 |
Completed
Has Results |
Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder |
- Depressive Disorder, Major
|
- Drug: Vortioxetine
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
- Percentage of Participants With a MADRS Response at Week 8
- Percentage of Participants in MADRS Remission at Week 8
- (and 2 more...)
|
600 |
All |
20 Years to 64 Years (Adult) |
NCT01255787 |
LuAA21004/CCT-002
2010-022257-41
U1111-1117-6595
JapicCTI-101344
CTRI/2011/08/001963 |
|
November 2010 |
March 2012 |
April 2012 |
December 7, 2010 |
December 18, 2013 |
December 18, 2013 |
- Split, Croatia
- Zagreb, Croatia
- Helsinki, Finland
- (and 70 more...)
|
| 4 |
NCT01163266 |
Completed
Has Results |
Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder |
- Depressive Disorder, Major
|
- Drug: Vortioxetine
- 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 Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
- Percentage of Participants With a MADRS Response at Week 8
- Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8
- (and 3 more...)
|
462 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01163266 |
LuAA21004_316
U1111-1115-8770 |
|
July 2010 |
January 2012 |
January 2012 |
July 15, 2010 |
December 18, 2013 |
December 18, 2013 |
- Anaheim, California, United States
- Cerritos, California, United States
- Costa Mesa, California, United States
- (and 36 more...)
|
| 5 |
NCT00672958 |
Completed
Has Results |
Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Vortioxetine
- 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 6
- Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
- Percentage of Responders in HAM-D24 Total Score by Study Visit
- (and 10 more...)
|
600 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00672958 |
LuAA21004_303
U1111-1114-2328 |
|
April 2008 |
November 2008 |
November 2008 |
May 6, 2008 |
December 13, 2013 |
December 13, 2013 |
- Birmingham, Alabama, United States
- Cerritos, California, United States
- Encino, California, United States
- (and 30 more...)
|
| 6 |
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, Senior) |
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...)
|
| 7 |
NCT03108625 |
Enrolling by invitation |
Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age |
- Depressive Disorder, Major
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events (Safety)
- Change in CDRS-R total score
- Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
- (and 9 more...)
|
170 |
All |
7 Years to 17 Years (Child) |
NCT03108625 |
12712B
2015-002658-11 |
|
March 1, 2017 |
October 2020 |
October 2020 |
April 11, 2017 |
March 22, 2018 |
|
- MHAT "Targovishte" AD
Targovishte, Bulgaria - DCC Mladost-M
Varna, Bulgaria - Marienthal Center of Psychiatry and Psychology
Tallinn, Estonia - (and 26 more...)
|
| 8 |
NCT02371980 |
Recruiting |
Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Vortioxetine
- Drug: Placebo
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time from Randomization to Relapse of Major Depressive Disorder During the First 28 Weeks of the 32-Week Double-Blind Treatment Period
- Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
- Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at Each Week Assessed
- (and 2 more...)
|
228 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02371980 |
LuAA21004_402
U1111-1161-4956 |
|
February 18, 2015 |
May 1, 2019 |
May 1, 2019 |
February 26, 2015 |
February 13, 2018 |
|
- NoesisPharma
Phoenix, Arizona, United States - SW Biomedical Research, LLC
Tucson, Arizona, United States - CNS Research Science, Inc.
Cerritos, California, United States - (and 76 more...)
|
| 9 |
NCT02871297 |
Enrolling by invitation |
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age |
- Depressive Disorder, Major
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety
- Change in CDRS-R total score
- Time to first relapse (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
- (and 9 more...)
|
850 |
All |
7 Years to 18 Years (Child, Adult) |
NCT02871297 |
12712A
2008-005356-25 |
|
August 2016 |
April 2019 |
April 2019 |
August 18, 2016 |
March 22, 2018 |
|
- US1333
Tucson, Arizona, United States - US1386
Wichita, Kansas, United States - US1051
Cincinnati, Ohio, United States - (and 56 more...)
|
| 10 |
NCT01323478 |
Completed
Has Results |
Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults |
- Major Depressive Disorder
|
- Drug: Vortioxetine (Lu AA21004)
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients With Adverse Events (AEs)
- Percentage of Patients Who Withdrew Due to Intolerance to Treatment
- Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
- (and 7 more...)
|
71 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01323478 |
13267B
2010-024198-38 |
|
April 2011 |
September 2012 |
October 2012 |
March 25, 2011 |
February 11, 2014 |
February 11, 2014 |
|
| 11 |
NCT00761306 |
Completed
Has Results |
Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults |
- Major Depressive Disorder
|
- Drug: Vortioxetine (Lu AA21004)
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients With Adverse Events (AEs)
- Percentage of Patients Who Withdrew Due to Intolerance to Treatment
- Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
- (and 3 more...)
|
74 |
All |
18 Years to 65 Years (Adult) |
NCT00761306 |
11492C
2007-000905-31 |
|
June 2007 |
September 2008 |
October 2008 |
September 29, 2008 |
January 29, 2014 |
December 17, 2013 |
|
| 12 |
NCT00735709 |
Completed
Has Results |
Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Vortioxetine
- 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 Sheehan Disability Scale (SDS) Total Score at Week 8
- Clinical Global Impression Scale-Global Improvement at Week 8
- (and 23 more...)
|
560 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00735709 |
LuAA21004_305
2008-001580-11
U1111-1114-0326 |
|
August 2008 |
July 2009 |
August 2009 |
August 15, 2008 |
December 18, 2013 |
December 18, 2013 |
- Elizabeth Vale, Australia
- Southport, Australia
- Litomerice, Czech Republic
- (and 47 more...)
|
| 13 |
NCT00694304 |
Completed
Has Results |
Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults |
- Major Depressive Disorder
|
- Drug: Vortioxetine (Lu AA21004)
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients With Adverse Events (AEs)
- Percentage of Patients Who Withdrew Due to Intolerance to Treatment
- Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
- (and 7 more...)
|
535 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00694304 |
11984B
EudraCT 2007-004992-21 |
|
May 2008 |
March 2010 |
April 2010 |
June 10, 2008 |
April 1, 2014 |
April 1, 2014 |
|
| 14 |
NCT01355081 |
Completed
Has Results |
Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Vortioxetine
- 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 Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment
- Percentage of Patients With MADRS Response After 8 Weeks of Treatment
- Percentage of Patients With MADRS Remission After 8 Weeks of Treatment
- (and 3 more...)
|
366 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT01355081 |
LuAA21004/CCT-003
U1111-1120-9277
JapicCTI-111492 |
|
May 2011 |
December 2012 |
December 2012 |
May 17, 2011 |
November 11, 2014 |
November 11, 2014 |
- Inzai-shi, Chiba, Japan
- Noda-City, Chiba, Japan
- Fukuoka-city, Fukuoka, Japan
- (and 29 more...)
|
| 15 |
NCT01153009 |
Completed
Has Results |
Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder |
- Depressive Disorder, Major
|
- Drug: Vortioxetine
- Drug: Duloxetine
- 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
- Percentage of Participants With a MADRS Response at Week 8
- Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8
- (and 3 more...)
|
614 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01153009 |
LuAA21004_315
U1111-1114-8191 |
|
June 2010 |
March 2012 |
March 2012 |
June 29, 2010 |
December 18, 2013 |
December 18, 2013 |
- Beverly Hills, California, United States
- Chino, California, United States
- Garden Grove, California, United States
- (and 53 more...)
|
| 16 |
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, Senior) |
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...)
|
| 17 |
NCT02272517 |
Completed |
Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Vortioxetine 10-20 mg
- Drug: Escitalopram 10-20 mg
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in Digit Symbol Substitution Test (DSST)
- Change in Rey Auditory Verbal Learning Test (RAVLT)
- Change in Trail Making Test A (TMT-A)
- (and 11 more...)
|
101 |
All |
18 Years to 65 Years (Adult) |
NCT02272517 |
15907A
2014-000231-16 |
|
December 2014 |
March 2016 |
March 2016 |
October 23, 2014 |
February 28, 2017 |
|
- FI005
Helsinki, Finland - FI001
Kuopio, Finland - FI006
Kupio, Finland - (and 13 more...)
|
| 18 |
NCT01488071 |
Completed
Has Results |
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication |
- Major Depressive Disorder
|
- Drug: Vortioxetine (Lu AA21004)
- Drug: Agomelatine
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in MADRS Total Score at Week 8
- Change From Baseline in MADRS Total Score at Week 12
- Change From Baseline in HAM-A Total Score at Week 8
- (and 11 more...)
|
495 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01488071 |
14178A
2011-002362-21 |
REVIVE |
January 2012 |
December 2012 |
|
December 8, 2011 |
March 26, 2014 |
March 26, 2014 |
|
| 19 |
NCT02749721 |
Recruiting |
The Relationship Among Changes in Brain Network Activation in Adult Outpatients With Major Depressive Disorder |
- Major Depressive Disorder
|
|
Interventional |
Phase 4 |
- Rush University Medical Center
- Takeda Pharmaceuticals North America, Inc.
- ElMindA Ltd
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Change in Montgomery and Asberg Depression Rating Scale (MADRS)
|
50 |
All |
18 Years to 65 Years (Adult) |
NCT02749721 |
IISR-2014-100702a |
|
December 2016 |
December 2018 |
February 2019 |
April 25, 2016 |
March 30, 2018 |
|
- Rush University Medical Center
Chicago, Illinois, United States - Rush University Medical Center
Skokie, Illinois, United States
|
| 20 |
NCT01571453 |
Completed
Has Results |
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries |
- Major Depressive Disorder
|
- Drug: Vortioxetine (Lu AA21004)
- Drug: Venlafaxine extended release
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in MADRS Total Score at Week 8
- Change in CGI-S Score From Baseline to Week 8
- CGI-I Score at Week 8
- (and 4 more...)
|
437 |
All |
18 Years to 65 Years (Adult) |
NCT01571453 |
13926A |
|
May 2012 |
October 2013 |
|
April 5, 2012 |
October 13, 2014 |
October 13, 2014 |
|
| 21 |
NCT00811252 |
Completed
Has Results |
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients |
- Major Depressive Disorder
|
- Drug: Placebo
- Drug: Vortioxetine (Lu AA21004)
- Drug: Duloxetine
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
- Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
- Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
- (and 10 more...)
|
453 |
All |
65 Years and older (Adult, Senior) |
NCT00811252 |
12541A
2008-002901-38 |
|
January 2009 |
February 2010 |
March 2010 |
December 18, 2008 |
January 29, 2014 |
December 18, 2013 |
|
| 22 |
NCT02709746 |
Recruiting |
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD) |
- Depressive Disorder, Major
|
- Drug: Vortioxetine 10 mg/day
- Drug: Vortioxetine 20 mg/day
- Drug: Fluoxetine 20 mg/day
- Other: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in CDRS-R total score after treatment
- Change in CDRS-R total score during treatment
- CDRS-R response (defined as >50% reduction in the CDRS-R total score (subtracted 17 points))
- (and 11 more...)
|
750 |
All |
12 Years to 17 Years (Child) |
NCT02709746 |
12710A
2008-005354-20 |
|
May 2016 |
October 2018 |
October 2018 |
March 16, 2016 |
March 22, 2018 |
|
- US1369
Dothan, Alabama, United States - US1333
Tucson, Arizona, United States - US1310
Little Rock, Arkansas, United States - (and 118 more...)
|
| 23 |
NCT02279953 |
Completed |
Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Vortioxetine 10-20 mg
- Drug: Placebo
- Drug: SSRI
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in Digit Symbol Substitution Test (DSST): number of correct symbols
- Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition])
- Change in Trail Making Test (TMT) score: TMT-A; speed of processing
- (and 12 more...)
|
151 |
All |
18 Years to 65 Years (Adult) |
NCT02279953 |
15905A
2014-000229-19 |
|
October 2014 |
April 2016 |
April 2016 |
October 31, 2014 |
May 24, 2017 |
|
- EE001
Tallinn, Estonia - EE002
Tallinn, Estonia - FI002
Helsinki, Finland - (and 14 more...)
|
| 24 |
NCT02279966 |
Completed |
Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Vortioxetine 10 mg
- Drug: Paroxetine 20 mg
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in Digit Symbol Substitution Test (DSST): number of correct symbols
- Change in Trail Making Test (TMT) score: TMT-A; speed of processing
- Change in TMT-B; executive functioning
- (and 10 more...)
|
152 |
All |
18 Years to 65 Years (Adult) |
NCT02279966 |
15906A
2014-000230-34 |
|
October 2014 |
February 2016 |
February 2016 |
October 31, 2014 |
February 28, 2017 |
|
- EE001
Tallinn, Estonia - EE002
Tallinn, Estonia - EE004
Voru, Estonia - (and 15 more...)
|
| 25 |
NCT01422213 |
Completed
Has Results |
Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Placebo
- Drug: Vortioxetine (Lu AA21004)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores
- Change From Baseline to Week 8 in DSST (Number of Correct Symbols)
- Change From Baseline to Week 8 in RAVLT (Acquisition)
- (and 15 more...)
|
598 |
All |
18 Years to 65 Years (Adult) |
NCT01422213 |
14122A
2011-001572-19 |
FOCUS |
December 2011 |
May 2013 |
|
August 23, 2011 |
August 5, 2014 |
August 5, 2014 |
|
| 26 |
NCT02919501 |
Completed |
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder |
- Depressive Disorder, Major
|
- Drug: Vortioxetine (IV)
- Other: Placebo (IV)
- Drug: Vortioxetine (tablet)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline to Week 1 in MADRS total score
- Change from baseline to Week 2 in MADRS total score
- Change from baseline to Day 3 in MADRS total score
- (and 9 more...)
|
55 |
All |
18 Years to 65 Years (Adult) |
NCT02919501 |
16903A
2015-005081-30 |
|
September 27, 2016 |
April 27, 2017 |
April 27, 2017 |
September 29, 2016 |
July 7, 2017 |
|
- EE1019
Tallinn, Estonia - EE1020
Tallinn, Estonia - FI1040
Helsinki, Finland - (and 4 more...)
|
| 27 |
NCT02454426 |
Withdrawn |
Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease |
- Major Depressive Disorder
- Coronary Artery Disease
|
|
Interventional |
Early Phase 1 |
- Thomas Jefferson University
- Takeda
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Severity of depressive episodes measured using the Montgomery-Asberg Depression Rating Scale (MADRS)
|
0 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02454426 |
TakedaHRV |
|
April 2016 |
June 2016 |
June 2016 |
May 27, 2015 |
August 25, 2016 |
|
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
| 28 |
NCT02389816 |
Completed |
A Phase 3 Study of Lu AA21004 in Patients With Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Placebo
- Drug: Lu AA21004
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The change from baseline (i.e. the start of double-blind treatment) in the MADRS(Montgomery-Åsberg Depression Rating Scale) total score after 8 weeks of treatment.
- MADRS response (defined as a ≥50% decrease in the MADRS total score from Baseline) after 8 weeks of treatment (Last Observation Carried Forward (LOCF)).
- MADRS remission(defined as a MADRS total score ≤10) after 8 weeks of treatment (LOCF).
- (and 6 more...)
|
492 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT02389816 |
LuAA21004/CCT-004
U1111-1167-1520
JapicCTI-152831 |
|
April 10, 2015 |
March 16, 2018 |
March 16, 2018 |
March 17, 2015 |
March 30, 2018 |
|
- Nagoya, Aichi, Japan
- Noda, Chiba, Japan
- Ruzan, Chiba, Japan
- (and 44 more...)
|
| 29 |
NCT01140906 |
Completed
Has Results |
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults |
- Major Depressive Disorder
|
- Drug: Placebo
- Drug: Vortioxetine (Lu AA21004)
- Drug: Duloxetine
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.
- Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
- Change in Clinical Status Using CGI-I Score at Week 8
- (and 5 more...)
|
607 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01140906 |
13267A
2009-017523-26 |
|
May 2010 |
September 2011 |
|
June 10, 2010 |
February 11, 2014 |
February 11, 2014 |
|
| 30 |
NCT01395147 |
Completed |
Long-Term Extension Study of Lu AA21004 in Participants With Major Depressive Disorder |
- Major Depressive Disorder
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants Reporting One or More Treatment-emergent Adverse Events
- Number of Participants With Markedly Abnormal Laboratory Values
- Significant Change from Baseline in Body Weight
- (and 6 more...)
|
119 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT01395147 |
LuAA21004/OCT-001
JapicCTI-111530
U1111-1122-3910 |
|
July 2011 |
May 2013 |
May 2013 |
July 15, 2011 |
November 5, 2013 |
|
- Inzai-shi, Chiba, Japan
- Noda-City, Chiba, Japan
- Fukuoka-city, Fukuoka, Japan
- (and 29 more...)
|
| 31 |
NCT02709655 |
Recruiting |
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder (MDD) |
- Depressive Disorder, Major
|
- Drug: Vortioxetine 10 mg/day
- Drug: Vortioxetine 20 mg/day
- Drug: Fluoxetine 20mg/day
- Other: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in CDRS-R total score after treatment
- Change in CDRS-R total score during treatment
- CDRS-R response (defined as >50% reduction in the CDRS-R total score (subtracted 17 points))
- (and 10 more...)
|
750 |
All |
7 Years to 11 Years (Child) |
NCT02709655 |
12709A
2008-005353-38 |
|
May 2016 |
October 2018 |
October 2018 |
March 16, 2016 |
March 22, 2018 |
|
- US1369
Dothan, Alabama, United States - US1310
Little Rock, Arkansas, United States - US1387
Downey, California, United States - (and 119 more...)
|
| 32 |
NCT00635219 |
Completed
Has Results |
Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder |
- Major Depressive Disorder
|
- Drug: Placebo
- Drug: Vortioxetine (Lu AA21004)
- Drug: Duloxetine
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
- Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
- Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
- (and 7 more...)
|
766 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00635219 |
11984A
EudraCT 2007-001870-95 |
|
February 2008 |
April 2009 |
April 2009 |
March 13, 2008 |
February 11, 2014 |
February 11, 2014 |
|
| 33 |
NCT01152996 |
Completed
Has Results |
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study |
- Depressive Disorder, Major
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%
- Number of Participants With Serious Treatment-Emergent Adverse Events
- Treatment-Emergent Adverse Events Leading to Study Discontinuation
- (and 7 more...)
|
1075 |
All |
18 Years to 77 Years (Adult, Senior) |
NCT01152996 |
LuAA21004_314
U1111-1115-4927 |
|
September 2010 |
May 2013 |
May 2013 |
June 29, 2010 |
May 28, 2014 |
May 28, 2014 |
|
| 34 |
NCT01564862 |
Completed
Has Results |
Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder |
- Depressive Disorder, Major
|
- Drug: vortioxetine (Lu AA21004)
- Drug: Duloxetine
- Drug: Placebo
|
Interventional |
Phase 2 |
|
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 Digit Symbol Substitution Test (DSST)
- Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore
- Clinical Global Impressions-Improvement (CGI-I) Score at Week 8
- (and 12 more...)
|
602 |
All |
18 Years to 65 Years (Adult) |
NCT01564862 |
LuAA21004_202
2011-005298-22
U1111-1126-0091 |
|
April 2012 |
February 2014 |
February 2014 |
March 28, 2012 |
February 5, 2015 |
February 5, 2015 |
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Bellflower, California, United States
- (and 89 more...)
|
| 35 |
NCT01607125 |
Completed |
Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls |
|
- Drug: Vortioxetine (Lu AA21004)
- Drug: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)
- Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory
- Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing
|
96 |
All |
25 Years to 55 Years (Adult) |
NCT01607125 |
14137A
2011-001839-23 |
|
July 2012 |
September 2013 |
|
May 28, 2012 |
September 25, 2013 |
|
- GB001
Headington, United Kingdom
|
| 36 |
NCT00839423 |
Completed
Has Results |
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults |
- Major Depressive Disorder
|
- Drug: Placebo
- Drug: Vortioxetine (Lu AA21004)
- Drug: Venlafaxine XL
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
- Change From Baseline in MADRS Total Score After 1 Week of Treatment
- Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
- (and 5 more...)
|
426 |
All |
18 Years to 65 Years (Adult) |
NCT00839423 |
11492A
2006-001515-29 |
|
August 2006 |
August 2007 |
September 2007 |
February 9, 2009 |
May 13, 2014 |
December 17, 2013 |
|
| 37 |
NCT02332954 |
Completed |
Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine |
- Major Depressive Disorder
|
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- the association/correlation between changes in patient-reported cognitive symptoms and work productivity. (Perceived Deficit Questionnaire-Depression)
- Cognitive function (PDQ-D-20)
- Cognitive function (Digit Symbol Substitution Test (DSST)
- (and 7 more...)
|
226 |
All |
18 Years to 65 Years (Adult) |
NCT02332954 |
15913A |
AtWoRC |
February 2015 |
July 6, 2017 |
July 6, 2017 |
January 7, 2015 |
January 30, 2018 |
|
- CA004
Edmonton, Alberta, Canada - CA005
Kelowna, British Columbia, Canada - CA006
St. John's, Newfoundland and Labrador, Canada - (and 23 more...)
|
| 38 |
NCT00596817 |
Completed
Has Results |
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes |
- Major Depressive Disorder
|
- Drug: Placebo
- Drug: Vortioxetine (Lu AA21004)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
- Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
- Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment
- (and 6 more...)
|
639 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00596817 |
11985A
2007-001871-13 |
|
December 2007 |
September 2009 |
October 2009 |
January 17, 2008 |
March 31, 2014 |
March 31, 2014 |
|
| 39 |
NCT03053362 |
Not yet recruiting |
THINC-it Vortioxetine - Sensitivity to Change |
- Major Depressive Disorder
- Cognitive Change
|
- Drug: Vortioxetine
- Other: THINC-it Tool
|
Interventional |
Phase 2
Phase 3 |
- Brain and Cognition Discovery Foundation
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Cognition measured using the THINC-it tool
- Early changes in mood as measured by the Montgomery Åsberg Depression Rating Scale
- Early changes in cognition using Sheehan Disability Scale
- (and 2 more...)
|
150 |
All |
18 Years to 65 Years (Adult) |
NCT03053362 |
Pro00020418 |
|
March 2017 |
September 2018 |
September 2018 |
February 15, 2017 |
February 15, 2017 |
|
|
| 40 |
NCT02294305 |
Active, not recruiting |
Vortioxetine Versus Placebo in Major Depressive Disorder Comorbid With Social Anxiety Disorder |
- Social Anxiety Disorder
- Major Depressive Disorder
|
- Drug: Vortioxetine
- Drug: Placebo
|
Interventional |
Phase 4 |
- The Medical Research Network
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinical Global Impression of Improvement (CGI-I) Responder Rate
- Change in total Montgomery Asberg Depression Rating Scale (MADRS) score
- Change in total Liebowitz Social Anxiety Scale (LSAS) score
|
40 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02294305 |
TAK-S001560 |
|
December 2014 |
November 2016 |
November 2016 |
November 19, 2014 |
August 24, 2016 |
|
- The Medical Research Network, LLC
New York, New York, United States
|
| 41 |
NCT02845349 |
Withdrawn |
Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI) |
|
- Drug: Vortioxetine
- Drug: Placebo
|
Interventional |
Phase 3 |
- Johns Hopkins University
- Takeda
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction of depressive symptoms at 12 weeks as assessed by the Hamilton Depression Scale 17 items (HAMD-17)
- Reduction of depressive symptoms at 12 weeks as assessed by the Clinical Global Impression Improvement (CGI-I) scale
- Comparison of rates and severity of side-effects and adverse effects in subjects in the treatment arm versus placebo at week 1-12
- (and 2 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT02845349 |
IRB00105196 |
|
October 2016 |
October 2018 |
October 2018 |
July 27, 2016 |
September 2, 2016 |
|
|
| 42 |
NCT01364649 |
Completed
Has Results |
Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction |
|
- Drug: Vortioxetine
- Drug: Escitalopram
- 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 Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8
- Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed
- Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed
|
447 |
All |
18 Years to 55 Years (Adult) |
NCT01364649 |
LuAA21004_318
U1111-1120-3483 |
|
June 2011 |
December 2013 |
December 2013 |
June 2, 2011 |
October 9, 2014 |
October 9, 2014 |
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Anaheim, California, United States
- (and 59 more...)
|
| 43 |
NCT02234362 |
Completed
Has Results |
Vortioxetine for Menopausal Depression |
- Depression
- Menopause
- Vasomotor Disturbance
- (and 2 more...)
|
|
Interventional |
Phase 4 |
- Massachusetts General Hospital
- Takeda Pharmaceuticals North America, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)
- Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)
- Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)
- (and 11 more...)
|
47 |
Female |
40 Years to 62 Years (Adult) |
NCT02234362 |
2014P001812 |
|
June 12, 2015 |
September 29, 2016 |
September 29, 2016 |
September 9, 2014 |
June 28, 2017 |
May 2, 2017 |
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 44 |
NCT03187093 |
Recruiting |
Cognitive Dysfunction in MDD Patients |
- Major Depressive Disorder
|
- Drug: Vortioxetine
- Drug: Escitalopram
|
Interventional |
Phase 4 |
- Oleg Levada
- State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline to week 8 in DSST
- Change from baseline to week 8 in MADRS
- Change from baseline to week 8 in PDQ-5-D
- (and 8 more...)
|
150 |
All |
20 Years to 60 Years (Adult) |
NCT03187093 |
11031215 |
|
October 2016 |
July 2018 |
September 2018 |
June 14, 2017 |
June 16, 2017 |
|
- State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"
Zaporizhzhia, Ukraine
|
| 45 |
NCT02637466 |
Withdrawn |
Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers |
- Unipolar Major Depression
- Stage I, II or III Breast Cancer
|
|
Interventional |
Phase 4 |
- University of Miami
- Takeda
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
|
0 |
Female |
18 Years to 75 Years (Adult, Senior) |
NCT02637466 |
20150753 |
|
July 2016 |
July 2018 |
July 2019 |
December 22, 2015 |
September 30, 2016 |
|
|
| 46 |
NCT01491035 |
Completed
Has Results |
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder |
- Depressive Disorder
- Anxiety Disorder
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cmax of Vortioxetine
- AUC(0-24h) of Vortioxetine
- t½ of Vortioxetine
- (and 4 more...)
|
48 |
All |
7 Years to 17 Years (Child) |
NCT01491035 |
12708A
2010-020170-42 |
|
April 2012 |
December 2014 |
June 2015 |
December 13, 2011 |
March 16, 2017 |
January 15, 2016 |
- US003
Washington, District of Columbia, United States - US004
Wichita, Kansas, United States - US002
Cincinnatti, Ohio, United States - (and 4 more...)
|
| 47 |
NCT02969876 |
Recruiting |
Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine |
- Depressive Disorder
- Major Depression
- Depression
- Depression, Unipolar
|
|
Interventional |
Phase 4 |
- Massachusetts General Hospital
- Takeda
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Mnemonic Similarity Task
- Brain Derived Neurotrophic Factors Levels in the Blood
- Quick Inventory of Depressive Symptomatology
- (and 2 more...)
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT02969876 |
2016P001243 |
VOR-IISR |
November 2016 |
November 2017 |
November 2017 |
November 21, 2016 |
November 21, 2016 |
|
- the Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 48 |
NCT03485274 |
Not yet recruiting
New |
Substance Misuse To Psychiatric Disorders for Cannabis |
- Cannabis Use Disorder
- Depressive State
- Anxiety State
- (and 3 more...)
|
- Drug: Vortioxetine
- Other: Treatment as Usual
|
Interventional |
Phase 2
Phase 3 |
- The University of Hong Kong
- Queen Mary Hospital, Hong Kong
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- change in severity of Cannabis Use Disorder (CUD)
- prevalence of Cannabis induced mood disorder
- Change in Hamilton anxiety (HAM-A) rating scale
- (and 2 more...)
|
70 |
All |
16 Years to 30 Years (Child, Adult) |
NCT03485274 |
SToP-C |
|
May 1, 2018 |
May 31, 2019 |
August 1, 2019 |
April 2, 2018 |
April 3, 2018 |
|
|
| 49 |
NCT02883660 |
Completed |
Genecept Assay and Adverse Effects of Antidepressants |
- Depression
- Adverse Effects
|
|
Observational |
|
- Thomas Jefferson University
|
Other |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
- Poor metabolizers have more side effects
- Homozygenous for short allele of SLC6A4 will result in more side effects
|
74 |
All |
18 Years and older (Adult, Senior) |
NCT02883660 |
13P.25 |
|
February 2013 |
July 1, 2017 |
February 1, 2018 |
August 30, 2016 |
March 16, 2018 |
|
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
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