Major Depressive Disorder Clinical Trial
Official title:
A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
Status | Completed |
Enrollment | 1036 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or female subjects between 18 and 65 years of age, with a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) which is equal to or greater than 8 weeks in duration. - Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit). - Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four adequate antidepressant treatments. Exclusion Criteria: - Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug. - Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration. - Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress disorder. - Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pacific Clinical Research Medical Group | Arcadia | California |
United States | Pharmasite Research | Baltimore | Maryland |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Brooklyn Medical Institute | Brooklyn | New York |
United States | Northbrooke Research Center | Brown Deer | Wisconsin |
United States | Psychiatric Alliance of the Blue Ridge | Charlottesville | Virginia |
United States | Center for Emotional Fitness | Cherry Hill | New Jersey |
United States | Carolina Clinical Research Services | Columbia | South Carolina |
United States | FutureSearch Trials of Dallas | Dallas | Texas |
United States | Midwest Clinical Research Center | Dayton | Ohio |
United States | Gulfcoast Clinical Research Center | Fort Myers | Florida |
United States | Clinical Insights | Glen Burnie | Maryland |
United States | Neuroscience, Inc. | Herndon | Virginia |
United States | Bayou City Research, Ltd. | Houston | Texas |
United States | Goldpoint Clinical Research, LLC | Indianapolis | Indiana |
United States | Clinical Neuroscience Solutions | Jacksonville | Florida |
United States | Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada |
United States | Florida Clinical Research Center | Maitland | Florida |
United States | Dean Foundation | Middleton | Wisconsin |
United States | Radiant Research | Murray | Utah |
United States | Medical & Behavioral Health Research | New York | New York |
United States | The Medical Research Network, LLC | New York | New York |
United States | Clinical Neurosciences Solutions | Orlando | Florida |
United States | Oregon Center for Clinical Investigations, Inc. | Portland | Oregon |
United States | Finger Lakes Clinical Research | Rochester | New York |
United States | Rochester Center for Behavioral Medicine | Rochester Hills | Michigan |
United States | Oregon Center for Clinical Investigations | Salem | Oregon |
United States | Artemis Institute for Clinical Research | San Diego | California |
United States | Summit Research Network | Seattle | Washington |
United States | California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California |
United States | Carman Research | Smyrna | Georgia |
United States | Stedman Clinical Trials | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical Development & Commercialization, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants With Adverse Events (AEs). | An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug. | After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit | Yes |
Secondary | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score. | The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing. | Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF]) | No |
Secondary | Mean Clinical Global Impression - Improvement (CGI-I) Scale Score. | The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline. | Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF) | No |
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