Major Depressive Disorder and IrritabilityPhase 3NCT02212613
Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability
A Phase 3 study testing Brexpiprazole in people with Major Depressive Disorder and Irritability, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder and Irritability
- What is being tested?
- Brexpiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Brexpiprazole
- Keywords
- Major Depressive Disorder, Mental Disorders, nonpsychotic episode, antipsychotic, Mood Disorder, psychotic disorder
- Medical subject headings
- Depressive Disorder, Major, Mental Disorders, Affective Disorders, Psychotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexpiprazoleDrug
Also called OPC-34712
Treatment (6 weeks) Up to 2 mg/day, once daily dose, tablets, orally
| Study group | Role | What they receive |
|---|---|---|
| Brexpiprazole | Experimental | Brexpiprazole - Up to 2 mg/day, once daily dose, tablets, orally Receives: Drug: Brexpiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 6
Secondary outcomes (12)
Change from Phase B baseline to Phase B Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Measured: Week 6
Change from Phase B baseline to Phase B Week 6 in Spielberger State Trait Anger Expression Inventory (STAXI-2) Part 1
Measured: Week 6
Change from Phase B baseline to Phase B Week 6 in Visual Analog Scale (VAS)
Measured: Week 6
Change from Phase B baseline to Phase B Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) score
Measured: Week 6
Clinical Global Impression - Improvement Scale (CGI-I) score at Phase B Week 6
Measured: 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
Measured: 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
Measured: Week 6
Change from Phase B baseline to Phase B Week 6 in Sheehan Disability Scale (SDS) 3-item mean score
Measured: Week 6
Change from Phase B baseline to Phase B Week 6 in Anger Attacks Questionnaire (AAQ) score
Measured: Week 6
Change from Phase B baseline to Phase B Week 6 in Symptoms of Depression Questionnaire (SDQ)
Measured: Week 6
Change from Phase B baseline to Phase B Week 6 in Kellner Symptom Questionnaire (KSQ)
Measured: Week 6
Change from Phase B baseline to Phase B Week 6 in Barratt Impulsiveness Scale 11 item (BIS-11) Total Score
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder and IrritabilityStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Junichi Hashimoto, PhD, Study director, Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212613
- Sponsor's protocol ID
- 331-13-004
- Status last verified
- Jul 2016
- First submitted
- 23 Jul 2014
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02212613
- Acronym / sponsor ID
- 331-13-004
- Keywords
- Major Depressive Disorder, Mental Disorders, nonpsychotic episode, antipsychotic, Mood Disorder, psychotic disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive treatment in subjects with Major Depressive Disorder with irritability
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brexpiprazole | Experimental | Drug: BrexpiprazoleBrexpiprazole - Up to 2 mg/day, once daily dose, tablets, orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexpiprazoleAlso: OPC-34712Treatment (6 weeks) Up to 2 mg/day, once daily dose, tablets, orally | Drug | Brexpiprazole |
Primary outcome
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
12 secondary outcomes
Change from Phase B baseline to Phase B Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Week 6
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
Change from Phase B baseline to Phase B Week 6 in Visual Analog Scale (VAS)
Time frame: Week 6
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
Clinical Global Impression - Improvement Scale (CGI-I) score at Phase B Week 6
Time frame: 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
Time frame: 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
Time frame: Week 6
Change from Phase B baseline to Phase B Week 6 in Sheehan Disability Scale (SDS) 3-item mean score
Time frame: Week 6
Change from Phase B baseline to Phase B Week 6 in Anger Attacks Questionnaire (AAQ) score
Time frame: Week 6
Change from Phase B baseline to Phase B Week 6 in Symptoms of Depression Questionnaire (SDQ)
Time frame: Week 6
Change from Phase B baseline to Phase B Week 6 in Kellner Symptom Questionnaire (KSQ)
Time frame: Week 6
Change from Phase B baseline to Phase B Week 6 in Barratt Impulsiveness Scale 11 item (BIS-11) Total Score
Time frame: Week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junichi Hashimoto, PhD study director
Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brexpiprazole in people with Major Depressive Disorder and Irritability, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.