Major Depressive Disorder With Mixed Features Clinical Trial
— RESOLVE 1Official 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
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.
| Status | Completed |
| Enrollment | 211 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 | State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia, | Saratov | |
| Russian Federation | City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit) | St. Petersburg | |
| Russian Federation | Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva" | St. Petersburg | |
| Russian Federation | Saint Nicholas Psychiatric Hospital. | St. Petersburg | |
| Russian Federation | Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka" | Stavropol | |
| Serbia | Institute of Mental Health | Belgrade | |
| Serbia | Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje" | Belgrade | |
| Serbia | Health Centre Cacak Department of Psychiatry | Cacak | |
| Serbia | Clinical Center Nis, Psychiatric Clinic | Gornja Toponica | |
| Serbia | Clinical Center Kragujevac, Psychiatric Clinic | Kragujevac | |
| Serbia | Clinic for Mental Health, Clinical Center Nis | Nis | |
| Serbia | Special Hospital for Psychiatric Diseases "Sveti Vracevi" | Vojvodina | |
| Serbia | Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic" | Vrsac | |
| Serbia | General Hospital "Djordje Joanovic" Psychiatric Dept. | Zrenjanin | |
| Ukraine | Dnipropetrovsk Regional Clinical Hospital named Mechnikov | Dnipropetrovsk | |
| Ukraine | State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry | Kharkiv | |
| Ukraine | Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2 | Kyiv | |
| Ukraine | "Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults | Lugansk | |
| Ukraine | Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20 | Lviv | |
| Ukraine | Odesa Regional Psychoneurological Dispensary, Outpatient Dept. | Odesa | |
| Ukraine | 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 | |
| United Kingdom | MAC Clinical Research Limited | Cannock | |
| United Kingdom | MAC Clinical Research Limited | Manchester | |
| United States | Birmingham Psychiatry Pharmaceutical Studies, Inc. | Birmingham | Alabama |
| United States | Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders | Boston | Massachusetts |
| United States | Social Psychiatric Research Inst. (SPRI) Clinical Trials | Brooklyn | New York |
| United States | Dept. of Psychiatry, UT Southwestern Medical Center | Dallas | Texas |
| United States | FutureSearch Trials of Dallas, LP | Dallas | Texas |
| United States | Midwest Clinical Research Center | Dayton | Ohio |
| United States | Psychiatry and Behavioral Sciences, Duke | Durham | North Carolina |
| United States | Synergy Clinical Research Center | Escondido | California |
| United States | Collaborative Neuroscience Network Inc. | Garden Grove | California |
| United States | Village Clinical Research Inc. | New York | New York |
| United States | Stanford -VA Palo Alto Health Care System | Palo Alto | California |
| United States | CRI Worldwide - Kirkbride | Philadelphia | Pennsylvania |
| United States | Clinical Innovations Inc. | Riverside | California |
| United States | Finger Lakes Clinical Research | Rochester | New York |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | Florida Clinical Research Center, LLC | Sarasota | Florida |
| United States | St. Charles Psychiatric Associates/Midwest Research Group | St. Charles | Missouri |
| United States | Behavioral Medical Research of Staten Island | Staten Island | New York |
| United States | Grayline Clinical Drug Trials | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Sunovion |
United States, Russian Federation, Serbia, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores | 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. | Baseline to Week 6 | No |
| Secondary | Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score | 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. | Baseline to Week 6 | No |
| Secondary | Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score | 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. | Baseline to Week 6 | No |
| Secondary | Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score | 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). | Baseline to Week 6 | No |
| Secondary | Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score | 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. | Baseline to Week 6 | No |
| Secondary | 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). | Baseline to Week 6 | No | |
| Secondary | Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of = 12 at Week 6 (LOCF) | Baseline to Week 6 | No |