Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability
- Conditions
- Major Depressive Disorder and Irritability
- Interventions
- Registration Number
- NCT02212613
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
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Have received a single, trial-approved SSRI or SNRI at an adequate dose for ≥ 6 weeks prior to screening
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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.)
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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
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Are right-handed (defined according to the Edinburgh Handedness Inventory) and have normal hearing and normal/corrected-to-normal vision
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Are willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period
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Eligibility confirmed through a telephone SAFER interview with the subject and an independent expert centralized rater
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- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brexpiprazole Brexpiprazole Brexpiprazole - Up to 2 mg/day, once daily dose, tablets, orally
- Primary Outcome Measures
Name Time Method 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 Week 6
- Secondary Outcome Measures
Name Time Method Clinical Global Impression - Improvement Scale (CGI-I) score at Phase B Week 6 Week 6 MADRS response rate, where response is defined as ≥ 50% reduction in respective total scores from Phase B baseline to Phase B Week 6 Week 6 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 Week 6 Change from Phase B baseline to Phase B Week 6 in Anger Attacks Questionnaire (AAQ) score Week 6 Change from Phase B baseline to Phase B Week 6 in Kellner Symptom Questionnaire (KSQ) Week 6 Change from Phase B baseline to Phase B Week 6 in Spielberger State Trait Anger Expression Inventory (STAXI-2) Part 1 Week 6 Change from Phase B baseline to Phase B Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) score Week 6 Change from Phase B baseline to Phase B Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score Week 6 Change from Phase B baseline to Phase B Week 6 in Visual Analog Scale (VAS) Week 6 Change from Phase B baseline to Phase B Week 6 in Sheehan Disability Scale (SDS) 3-item mean score Week 6 Change from Phase B baseline to Phase B Week 6 in Symptoms of Depression Questionnaire (SDQ) Week 6 Change from Phase B baseline to Phase B Week 6 in Barratt Impulsiveness Scale 11 item (BIS-11) Total Score Week 6
Trial Locations
- Locations (1)
Emory University
🇺🇸Atlanta, Georgia, United States