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Selective Serotonin Reuptake Inhibitor
Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
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 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 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 • 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
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
265 Previous Clinical Trials
168,648 Total Patients Enrolled