Major Depressive Disorder and Irritability
Conditions
Keywords
Major Depressive Disorder, Mental Disorders, nonpsychotic episode, antipsychotic, Mood Disorder, psychotic disorder
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
Interventions
DRUGBrexpiprazole
Treatment (6 weeks) Up to 2 mg/day, once daily dose, tablets, orally
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Visual Analog Scale (VAS) | 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 |
| 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 |
| 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 Sheehan Disability Scale (SDS) 3-item mean score | 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 Symptoms of Depression Questionnaire (SDQ) | 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 Barratt Impulsiveness Scale 11 item (BIS-11) Total Score | 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 |
Countries
United States
Outcome results
None listed