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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 whether a combination of two drugs is effective in treating PTSD.

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

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: SertralineExperimental Treatment1 Intervention
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: 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: Fixed 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

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
166,458 Total Patients Enrolled

Frequently Asked Questions

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

What are the main indications for Brexpiprazole?

"Brexpiprazole is often used to treat panic attacks, but it can also be useful in treating other conditions like premenstrual dysphoric disorder, major depressive disorder (mdd), and anxiety disorders."

Answered by AI

Could you tell me if this research is still recruiting test subjects?

"The listing on clinicaltrials.gov says that this study is still looking for 585 participants and is currently being conducted at 1 site. The trial was first posted on October 30th, 2019 and the last edit was made on November 14th, 2020."

Answered by AI

Could you please elaborate on the risks associated with taking Brexpiprazole?

"There is some evidence from previous trials to support the efficacy of Brexpiprazole, as well as data indicating that it is a safe medication. Our team at Power has given it a score of 3."

Answered by AI

How many people are being asked to take part in this experiment?

"According to the listing on clinicaltrials.gov, this research project is still open to new participants. The trial was first announced on October 30th, 2019 and received its last update November 14th, 2022. There is space for 585 individuals at the single location where the study is taking place."

Answered by AI

Will this experiment be able to test individuals who are over 30 years old?

"This trial requires that participants be aged 18-65, which is different from the 53 other studies targeting those under 18 and the 352 trials for patients 65 and over."

Answered by AI

Am I eligible to participate in this research?

"In order to be eligible for this trial, potential participants must be aged 18-65 and have moral injury. In addition, patients must have been displaying symptoms meeting the DSM-5 criteria for PTSD for a minimum of six months and receive a diagnosis of PTSD from the Mini International Neuropsychiatric Interview (MINI)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
2019. "Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04174170.
~109 spots leftby Apr 2025
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