Clinical trial NCT02196506: Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Keywords: OPC-34712
brexpiprazole
Major Depressive Disorder
Adjunctive Treatment
Anxious Distress
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2014-07-22
Enrollment: 837
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress

Detailed description: The introduction of atypical antipsychotics has created a renewed interest in adjunctive therapy for MDD, particularly for treatment-resistant MDD. Several atypical antipsychotics have been shown to enhance the response to ADT. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label ADT in depressed subjects with and without anxious distress.

Eligibility criteria: Inclusion Criteria:

* Male and Female subjects between 18-65 years of age, with diagnosis of major depressive disorder with or without anxious distress
* Current depressive episode must be at least 8 weeks in duration

Exclusion Criteria:

* Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome
* Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
* Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder

Primary outcomes:
measure: Change in the Montgomery-Asberg Depression
timeFrame: From baseline (end of Phase A [Week 8]) to week 14
Secondary outcomes:
measure: Change in the Sheehan Disability Scale (SDS) From Baseline to End of Treatment
timeFrame: From baseline (end of Phase A [Week 8]) to week 14
measure: Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulation With <25% Improvement From Baseline of Phase A to End of Phase A in MADRS Total Score
timeFrame: From baseline (end of Phase A [Week 8]) to week 14
measure: Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulations With Anxious Distress as Specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
timeFrame: From baseline (end of Phase A [Week 8]) to week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Beverly Hills
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hialeah
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Rochester Hills
country: United States
state: Michigan
city: Cherry Hill
country: United States
state: New Jersey
city: Jamaica
country: United States
state: New York
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Edmond
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Lincoln
country: United States
state: Rhode Island
city: Columbia
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Wichita Falls
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Woodstock
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Achim
country: Germany
city: Berlin
country: Germany
city: Dusseldorf
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Oranienburg
country: Germany
city: Stralsund
country: Germany
city: Wurzburg
country: Germany
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Gdansk
country: Poland
city: Lubin
country: Poland
city: Sosnowiec
country: Poland
city: Warszawa
country: Poland
city: Bratislava
country: Slovakia
city: Kosice-Barca
country: Slovakia
city: Liptovsky Mikulas
country: Slovakia
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Claudette Brewer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.
citation: Hobart M, Skuban A, Zhang P, Augustine C, Brewer C, Hefting N, Sanchez R, McQuade RD. A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Fixed-Dose Brexpiprazole 2 mg/d as Adjunctive Treatment of Adults With Major Depressive Disorder. J Clin Psychiatry. 2018 May 22;79(4):17m12058. doi: 10.4088/JCP.17m12058.