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Trial record 17 of 68 for:    Brexpiprazole

Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability

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ClinicalTrials.gov Identifier: NCT02212613
Recruitment Status : Withdrawn (Low enrollment)
First Posted : August 8, 2014
Last Update Posted : July 7, 2016
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder and Irritability Drug: Brexpiprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexpiprazole
Brexpiprazole - Up to 2 mg/day, once daily dose, tablets, orally
Drug: Brexpiprazole
Treatment (6 weeks) Up to 2 mg/day, once daily dose, tablets, orally
Other Name: OPC-34712




Primary Outcome Measures :
  1. 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 [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Change from Phase B baseline to Phase B Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Week 6 ]
  2. Change from Phase B baseline to Phase B Week 6 in Spielberger State Trait Anger Expression Inventory (STAXI-2) Part 1 [ Time Frame: Week 6 ]
  3. Change from Phase B baseline to Phase B Week 6 in Visual Analog Scale (VAS) [ Time Frame: Week 6 ]
  4. Change from Phase B baseline to Phase B Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) score [ Time Frame: Week 6 ]
  5. Clinical Global Impression - Improvement Scale (CGI-I) score at Phase B Week 6 [ Time Frame: Week 6 ]
  6. MADRS response rate, where response is defined as ≥ 50% reduction in respective total scores from Phase B baseline to Phase B Week 6 [ Time Frame: Week 6 ]
  7. 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 [ Time Frame: Week 6 ]
  8. Change from Phase B baseline to Phase B Week 6 in Sheehan Disability Scale (SDS) 3-item mean score [ Time Frame: Week 6 ]
  9. Change from Phase B baseline to Phase B Week 6 in Anger Attacks Questionnaire (AAQ) score [ Time Frame: Week 6 ]
  10. Change from Phase B baseline to Phase B Week 6 in Symptoms of Depression Questionnaire (SDQ) [ Time Frame: Week 6 ]
  11. Change from Phase B baseline to Phase B Week 6 in Kellner Symptom Questionnaire (KSQ) [ Time Frame: Week 6 ]
  12. Change from Phase B baseline to Phase B Week 6 in Barratt Impulsiveness Scale 11 item (BIS-11) Total Score [ Time Frame: Week 6 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212613


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Junichi Hashimoto, PhD Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02212613     History of Changes
Other Study ID Numbers: 331-13-004
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Major Depressive Disorder
Mental Disorders, nonpsychotic episode, antipsychotic
Mood Disorder, psychotic disorder
Additional relevant MeSH terms:
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Brexpiprazole
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents