Trials Sponsors Conditions Drugs Pricing

Conditions

Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders

Keywords

OPC-34712brexpiprazoleMajor Depressive DisorderAdjunctive Treatment

Outcome Measures

Primary Outcomes (1)

Adverse Events (AEs) - All Participants
To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.
From screening to week 52/early termination

Secondary Outcomes (4)

Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
From screening to week 52/early termination
Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
From screening to week 52/early termination

Study Arms (6)

OPC-34712 (Brexpiprazole) and Escitalopram

EXPERIMENTAL

OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day

Drug: OPC-34712Drug: Escitalopram

OPC-34712 and Fluoxetine

EXPERIMENTAL

OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day

Drug: OPC-34712Drug: Fluoxetine

OPC-34712 and Paroxetine CR

EXPERIMENTAL

Interventions

OPC-34712Drug

Tablet

OPC-34712 (Brexpiprazole) and EscitalopramOPC-34712 and DuloxetineOPC-34712 and FluoxetineOPC-34712 and Paroxetine CROPC-34712 and SertralineOPC-34712 and Venlafaxine XR

EscitalopramDrug

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and Female outpatients 18-65 years of age
Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:

Sponsors & Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.
Industrylead

Study Sites (142)

Research Site

Birmingham, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Beverly Hills, California, United States

Research Site

Costa Mesa, California, United States

Research Site

Glendale, California, United States

Research Site

Irvine, California, United States

Related Publications (2)

Newcomer JW, Meehan SR, Chen D, Brubaker M, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies. J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786.
PMID: 37656180DERIVED
Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.
PMID: 31577867DERIVED

MeSH Terms

Conditions

Depressive DisorderDepressionDepressive Disorder, MajorMood DisordersMental Disorders

Interventions

EscitalopramFluoxetineParoxetineSertralineDuloxetine HydrochlorideVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Results Point of Contact

Title: Global Clinical Development
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

2,944 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 26, 2011

Study Start

October 2011

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (6)

OPC-34712 (Brexpiprazole) and Escitalopram

OPC-34712 and Fluoxetine

OPC-34712 and Paroxetine CR

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (142)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

OPC-34712 and Sertraline

OPC-34712 and Duloxetine

OPC-34712 and Venlafaxine XR

You may not qualify if:

Data Sharing

Source record

Documents

Locations