Major Depressive Disorder and Irritability Clinical Trial
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
The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive treatment in subjects with Major Depressive Disorder with irritability
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
- 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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score | Week 6 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Spielberger State Trait Anger Expression Inventory (STAXI-2) Part 1 | Week 6 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Visual Analog Scale (VAS) | Week 6 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) score | Week 6 | No | |
| Secondary | Clinical Global Impression - Improvement Scale (CGI-I) score at Phase B Week 6 | Week 6 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Sheehan Disability Scale (SDS) 3-item mean score | Week 6 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Anger Attacks Questionnaire (AAQ) score | Week 6 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Symptoms of Depression Questionnaire (SDQ) | Week 6 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Kellner Symptom Questionnaire (KSQ) | Week 6 | No | |
| Secondary | Change from Phase B baseline to Phase B Week 6 in Barratt Impulsiveness Scale 11 item (BIS-11) Total Score | Week 6 | No |