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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 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

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 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 • NCT03149991

16%

Dizziness

16%

Alteration in Taste

12%

Restlessness/Akathisia

Headache

Dissociation/Detachment

Insomnia/Sleep disturbance

Sedation

Constipation

Gastric Distress

Elevated alt

Hot flashes

Increased appetite

Unsteadiness of gait

Lethargy

Twitching of left side lower lip

Light headedness

Panic episode

Shakiness

Irritability

Increased salivation post dose

Weight gain

Bruxism

Nausea

Bi-lateral hand pain

Euphoria

Irregular/Early Menses

100%

80%

60%

40%

20%

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