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Brexpiprazole for Depression

Phase 3
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 21, 23, 25, 29, 33, 37, 41, 45, and 46
Awards & highlights

Study Summary

This trial will study whether the addition of brexpiprazole to antidepressant therapy is safe and effective for treating major depressive disorder.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 21, 23, 25, 29, 33, 37, 41, 45, and 46
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 21, 23, 25, 29, 33, 37, 41, 45, and 46 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase C: Time-to-Relapse by Any Criteria as Defined in Blinded Addendum
Secondary outcome measures
Phase C: Change From Baseline for Randomization Phase in CGI-S Score at Week 46
Phase C: Change From Baseline for Randomization Phase in Each of the SDS Individual Item Scores at Week 46
Phase C: Change From Baseline for Randomization Phase in MADRS Total Score at Week 46
+4 more

Side effects data

From 2019 Phase 4 trial • 51 Patients • NCT03149991
16%
Alteration in Taste
16%
Dizziness
12%
Restlessness/Akathisia
8%
Insomnia/Sleep disturbance
8%
Gastric Distress
8%
Constipation
8%
Headache
8%
Sedation
8%
Dissociation/Detachment
4%
Euphoria
4%
Nausea
4%
Elevated alt
4%
Light headedness
4%
Irritability
4%
Irregular/Early Menses
4%
Bi-lateral hand pain
4%
Shakiness
4%
Increased appetite
4%
Hot flashes
4%
Increased salivation post dose
4%
Panic episode
4%
Weight gain
4%
Lethargy
4%
Bruxism
4%
Twitching of left side lower lip
4%
Unsteadiness of gait
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase C: Placebo + ADTExperimental Treatment1 Intervention
Eligible participants completing Phase B received brexpiprazole-matching placebo along with protocol-specified ADT, orally, for up to 26 weeks during Phase C.
Group II: Phase C: Brexpiprazole + ADTExperimental Treatment2 Interventions
Eligible participants completing Phase B received brexpiprazole 2 or 3 mg/day (dose of brexpiprazole that they were receiving at Week 20 of the Stabilization Phase) along with protocol-specified ADT, orally, for up to 26 weeks during Phase C.
Group III: Phase B: Brexpiprazole + ADTExperimental Treatment2 Interventions
Eligible participants completing Phase A were enrolled in Phase B to receive brexpiprazole 2 or 3 mg/day along with protocol-specified ADT, orally, for 12 weeks.
Group IV: Phase A: Brexpiprazole + ADTExperimental Treatment2 Interventions
Participants received brexpiprazole 2 or 3 milligrams per day (mg/day) along with protocol-specified antidepressant therapy (ADT), orally, for 6 to 8 weeks during Phase A. Participants were initially titrated to a target dose of brexpiprazole 2 mg over a 2 to 4-week period. Thereafter, participants who had not met response criteria as defined in the blinded addendum, did not have potentially dose-related adverse events (AEs), and had not achieved the maximum dose of medication had their dose increased up to 3 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antidepressant therapy
2018
Completed Phase 3
~1150
Brexpiprazole
FDA approved

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
245 Previous Clinical Trials
165,846 Total Patients Enrolled
28 Trials studying Depression
39,070 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder
2018. "A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03538691.
~170 spots leftby Apr 2025
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