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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

Study Summary

This trial will test a new combination treatment for PTSD made up of two existing drugs. It will compare the new treatment to a placebo to see if it is more effective, safe, and tolerable.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score

Secondary outcome measures

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%

Alteration in Taste

16%

Dizziness

12%

Restlessness/Akathisia

Insomnia/Sleep disturbance

Gastric Distress

Constipation

Headache

Sedation

Dissociation/Detachment

Euphoria

Nausea

Elevated alt

Light headedness

Irritability

Irregular/Early Menses

Bi-lateral hand pain

Shakiness

Increased appetite

Hot flashes

Increased salivation post dose

Panic episode

Weight gain

Lethargy

Bruxism

Twitching of left side lower lip

Unsteadiness of gait

100%

80%

60%

40%

20%

Study treatment Arm

Brexpiprazole

Placebo

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, placebo or a combination of these. 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

~4150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

246 Previous Clinical Trials

166,599 Total Patients Enrolled

Frequently Asked Questions

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

Are participants being enrolled in this research project currently?

"Indeed, the information available on clinicaltrials.gov attests that this research is presently recruiting patients. This trial was first advertised on October 17th, 2019 with the most recent update occurring on July 14th, 2022. 577 individuals are needed across a single site."

Answered by AI

Could I potentially qualify to enroll in this research study?

"The PTSD study requires that patients are aged 18-65 and will involve 577 people in total."

Answered by AI

What conditions does Brexpiprazole typically address?

"Panic disorder is most commonly treated with the prescription medication Brexpiprazole. However, this drug can also be helpful for treating PMDD, MDD, and other anxiety disorders."

Answered by AI

Are we looking for elderly participants in this research project?

"The age range for patients that meet the inclusion criteria and can be enrolled in this clinical trial is 18-65."

Answered by AI

Does Brexpiprazole have any significant side effects?

"There is some evidence from earlier trials to support the efficacy of Brexpiprazole as well as multiple rounds of data that suggest it is safe. We give it a rating of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

2019. "Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04124614.