Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose (RESOLVE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01421134
Recruitment Status : Completed
First Posted : August 22, 2011
Results First Posted : October 9, 2015
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief Summary:
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder With Mixed Features Drug: Lurasidone Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features
Study Start Date : September 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lurasidone

Arm Intervention/treatment
Experimental: Lurasidone
Lurasidone 20, 40 or 60 mg
Drug: Lurasidone
20, 40, 60 mg, flexible dose, once daily PM 6 weeks
Other Name: Latuda

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores [ Time Frame: Baseline to Week 6 ]
    The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.


Secondary Outcome Measures :
  1. Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score [ Time Frame: Baseline to Week 6 ]
    The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.

  2. Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score [ Time Frame: Baseline to Week 6 ]
    The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.

  3. Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to Week 6 ]
    The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).

  4. Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score [ Time Frame: Baseline to Week 6 ]
    The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.

  5. Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF). [ Time Frame: Baseline to Week 6 ]
  6. Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF) [ Time Frame: Baseline to Week 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
  • Subject is 18 to 75 years of age, inclusive.
  • Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).
  • Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):

    • Elevated, expansive mood
    • Inflated self-esteem or grandiosity
    • More talkative than usual or pressure to keep talking
    • Flight of ideas or subjective experience that thoughts are racing
    • Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
    • Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
    • Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)

Exclusion Criteria:

  • Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
  • Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
  • Subject has attempted suicide within the past 3 months.
  • Subject has a lifetime history of any bipolar I manic or mixed manic episode.
  • Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421134


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States, 35226
United States, California
Synergy Clinical Research Center
Escondido, California, United States, 92025
Collaborative Neuroscience Network Inc.
Garden Grove, California, United States, 92845
Stanford -VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Clinical Innovations Inc.
Riverside, California, United States, 92506
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
United States, Florida
Florida Clinical Research Center, LLC
Sarasota, Florida, United States, 34201
United States, Massachusetts
Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, United States, 02114
United States, Missouri
St. Charles Psychiatric Associates/Midwest Research Group
St. Charles, Missouri, United States, 63301
United States, New York
Social Psychiatric Research Inst. (SPRI) Clinical Trials
Brooklyn, New York, United States, 11235
Village Clinical Research Inc.
New York, New York, United States, 10003
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Behavioral Medical Research of Staten Island
Staten Island, New York, United States, 10305
United States, North Carolina
Psychiatry and Behavioral Sciences, Duke
Durham, North Carolina, United States, 27705
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Pennsylvania
CRI Worldwide - Kirkbride
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States, 75231
Dept. of Psychiatry, UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8849
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
Russian Federation
Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov"
Saratov, Russian Federation, 410028
State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia,
Saratov, Russian Federation, 410060
Saint Nicholas Psychiatric Hospital.
St. Petersburg, Russian Federation, 190121
City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit)
St. Petersburg, Russian Federation, 191119
Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva"
St. Petersburg, Russian Federation, 193167
Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka"
Stavropol, Russian Federation, 355000
Serbia
Institute of Mental Health
Belgrade, Serbia, 11000
Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje"
Belgrade, Serbia, 11000
Health Centre Cacak Department of Psychiatry
Cacak, Serbia, 32000
Clinical Center Nis, Psychiatric Clinic
Gornja Toponica, Serbia, 18201
Clinical Center Kragujevac, Psychiatric Clinic
Kragujevac, Serbia, 34000
Clinic for Mental Health, Clinical Center Nis
Nis, Serbia, 18000
Special Hospital for Psychiatric Diseases "Sveti Vracevi"
Vojvodina, Serbia, 23330
Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
Vrsac, Serbia, 26300
General Hospital "Djordje Joanovic" Psychiatric Dept.
Zrenjanin, Serbia, 23000
Ukraine
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, Ukraine, 49005
State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry
Kharkiv, Ukraine, 61068
Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2
Kyiv, Ukraine, 08631
"Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults
Lugansk, Ukraine, 91045
Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20
Lviv, Ukraine, 79021
Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
Odesa, Ukraine, 65014
Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept. of Psychiatry and Narcology, Vinnytsya Regional Psychoneurological Hospital n.a. O.I. Yushchenko, Dept. no. 14, Dept. no 15
Vinnytsya, Ukraine, 21018
United Kingdom
MAC Clinical Research Limited
Cannock, United Kingdom, WS11 0BN
MAC Clinical Research Limited
Manchester, United Kingdom, M32 0UT
Sponsors and Collaborators
Sunovion
Investigators
Layout table for investigator information
Study Director: Medical Director, MD Sunovion

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01421134     History of Changes
Other Study ID Numbers: D1050304
First Posted: August 22, 2011    Key Record Dates
Results First Posted: October 9, 2015
Last Update Posted: July 15, 2016
Last Verified: July 2016
Keywords provided by Sunovion:
depression
Lurasidone
Latuda
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents