Clinical trial NCT02212613: Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability
Official title: Protocol 331-13-004: An Exploratory, Multicenter, Single-blind, fMRI Study of Fixed-dose Brexpiprazole (OPC 34712) (2 mg/Day Tablets) as an Adjunctive Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Major Depressive Disorder and Irritability
Keywords: Major Depressive Disorder
Mental Disorders, nonpsychotic episode, antipsychotic
Mood Disorder, psychotic disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2014-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive treatment in subjects with Major Depressive Disorder with irritability


Eligibility criteria: * Inclusion Criteria:

  * Are 18 to 55 years of age, inclusive, at the time of informed consent with a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR™) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation
  * Have received a single, trial-approved SSRI or SNRI at an adequate dose for ≥ 6 weeks prior to screening
  * Have a treatment history of inadequate ADT response to at least one ADT (but not \> 3) for the current episode. The current major depressive episode must be ≥ 6 weeks in duration. (An inadequate ADT response is defined as \< 50% reduction in depressive symptom severity, as measured by subject self-report on the MGH-ATRQ.)
  * To be eligible for this trial

    * Have a MADRS Total Score of 20 or more at screening and the Phase A baseline, and have a MADRS Total Score of 18 or more at the Phase B baseline
    * Have no more than 20% improvement in MADRS Total Score at Phase B baseline compared to Phase A baseline
    * Have a score of 6 or more on the KSQ based on the Well being and Reversal Distress Anger-hostility subscales at screening, Phase A baseline, and Phase B baseline
    * Have anger attacks as documented by the AAQ at screening, Phase A baseline, and Phase B baseline
  * Are right-handed (defined according to the Edinburgh Handedness Inventory) and have normal hearing and normal/corrected-to-normal vision
  * Are willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period
  * Eligibility confirmed through a telephone SAFER interview with the subject and an independent expert centralized rater
* Exclusion Criteria:

  * Have a current need for involuntary commitment or have been hospitalized within 4 weeks of screening for the current major depressive episode
  * Have a current DSM-IV-TR Axis I diagnosis of any of the following: delirium, dementia, amnestic, or other cognitive disorders; schizophrenia, schizoaffective disorder, or other psychotic disorders; bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified; eating disorders (including anorexia nervosa or bulimia); obsessive compulsive disorder; panic disorder; or post-traumatic stress disorder
  * Have any of the following current Axis II DSM-IV-TR diagnoses: borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental retardation
  * Experiencing hallucinations, delusions, or any psychotic symptomatology in the current major depressive episode

Primary outcomes:
measure: Change from Phase B baseline to Phase B Week 6 in functional magnetic resonance imaging (fMRI) BOLD activation score in the ventromedial prefrontal cortex and amygdala, scanned by fMRI during performance of the Emotion-induction Task
timeFrame: Week 6
Secondary outcomes:
measure: Change from Phase B baseline to Phase B Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Week 6
measure: Change from Phase B baseline to Phase B Week 6 in Spielberger State Trait Anger Expression Inventory (STAXI-2) Part 1
timeFrame: Week 6
measure: Change from Phase B baseline to Phase B Week 6 in Visual Analog Scale (VAS)
timeFrame: Week 6
measure: Change from Phase B baseline to Phase B Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) score
timeFrame: Week 6
measure: Clinical Global Impression - Improvement Scale (CGI-I) score at Phase B Week 6
timeFrame: Week 6
measure: MADRS response rate, where response is defined as ≥ 50% reduction in respective total scores from Phase B baseline to Phase B Week 6
timeFrame: Week 6
measure: MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Phase B baseline to Phase B Week 6
timeFrame: Week 6
measure: Change from Phase B baseline to Phase B Week 6 in Sheehan Disability Scale (SDS) 3-item mean score
timeFrame: Week 6
measure: Change from Phase B baseline to Phase B Week 6 in Anger Attacks Questionnaire (AAQ) score
timeFrame: Week 6
measure: Change from Phase B baseline to Phase B Week 6 in Symptoms of Depression Questionnaire (SDQ)
timeFrame: Week 6
measure: Change from Phase B baseline to Phase B Week 6 in Kellner Symptom Questionnaire (KSQ)
timeFrame: Week 6
measure: Change from Phase B baseline to Phase B Week 6 in Barratt Impulsiveness Scale 11 item (BIS-11) Total Score
timeFrame: Week 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
name: Junichi Hashimoto, PhD
role: STUDY_DIRECTOR
References: