Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447576
• Other study ID #: 331-08-212
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2011
• Last updated: October 6, 2015
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: October 2015
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• ADT
Once daily dosing during the duration of the study.
• OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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