Your session is about to expire
← Back to Search
Selective Serotonin Reuptake Inhibitor
Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With 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 is testing a combination of two medications, brexpiprazole and sertraline, in adults with PTSD. The goal is to see if this combination is safe and effective for people who may not respond well to standard treatments. Brexpiprazole helps balance brain chemicals, and sertraline boosts serotonin levels to improve mood. Brexpiprazole has shown potential benefits when combined with antidepressants.
Eligible Conditions
- Post Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
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 of Psychosocial Functions (B-IPF) score
Change in Clinical Global Impression - Severity (CGI-S) score
Side effects data
From 2019 Phase 4 trial • 51 Patients • NCT0314999116%
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%
Hot flashes
4%
Unsteadiness of gait
4%
Lethargy
4%
Increased appetite
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
Placebo Group
Group I: SertralineExperimental Treatment2 Interventions
3 pills: Fixed 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: Brexpiprazole + SertralineExperimental Treatment2 Interventions
3 pills: Fixed dose of up to 3 milligrams (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.
Group III: PlaceboPlacebo Group1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexpiprazole
2013
Completed Phase 4
~4040
Sertraline
2002
Completed Phase 4
~5470
Find a Location
Who is running the clinical trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
168,507 Total Patients Enrolled