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Selective Serotonin Reuptake Inhibitor

Brexpiprazole for Post-Traumatic Stress Disorder

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 up to 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial will test a new treatment combining two medications, brexpiprazole and sertraline, for adults with PTSD. Brexpiprazole helps balance brain chemicals, while sertraline improves mood. The goal is to see if this combination is safe, effective, and well-tolerated.

Eligible Conditions
  • Post Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score
Secondary study objectives
Change in Brief Inventory or Psychosocial Functions (B-IPF) score
Change in Clinical Global Impression - Severity (CGI-S) score

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: SertralineExperimental Treatment2 Interventions
3 pills: Dose up to 150 mg/ day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
Group II: PlaceboExperimental Treatment1 Intervention
3 pills: Brexpiprazole-matched placebo tablets and Sertraline-matched placebo tablets may be administered. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
Group III: Brexpiprazole + SertralineExperimental Treatment2 Interventions
3 pills: Dose of up to 3 mg /day may be administered of brexpiprazole, dose up to 150 mg/day may be administered of sertraline. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sertraline
2002
Completed Phase 4
~5470
Brexpiprazole
2013
Completed Phase 4
~4040

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
264 Previous Clinical Trials
169,629 Total Patients Enrolled
~75 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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