Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04124614 |
Recruitment Status :
Completed
First Posted : October 11, 2019
Last Update Posted : September 1, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post Traumatic Stress Disorder | Drug: Brexpiprazole Drug: Sertraline Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 450 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder |
Actual Study Start Date : | October 17, 2019 |
Actual Primary Completion Date : | July 19, 2023 |
Actual Study Completion Date : | August 8, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Brexpiprazole + Sertraline
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.
|
Drug: Brexpiprazole
Up to 3 mg pill
Other Name: Rexulti Drug: Sertraline Up to 150 mg pill
Other Name: Zoloft |
Experimental: Sertraline
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.
|
Drug: Sertraline
Up to 150 mg pill
Other Name: Zoloft Other: Placebo Pill |
Placebo
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.
|
Other: Placebo
Pill |
- Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score [ Time Frame: Up to 12 weeks ]CAPS-5 is a structured interview designed to assess PTSD diagnostic statusand symptoms severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The interview consists of 30 items, with a higher score indicating a worse outcome.
- Change in Clinical Global Impression - Severity (CGI-S) score [ Time Frame: Up to 12 weeks ]An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome. Change from baseline to assess efficacy
- Change in Brief Inventory or Psychosocial Functions (B-IPF) score [ Time Frame: Up to 12 weeks ]Patient-reported questionnaire consisting of 7 questions, each scored from 0 to 6, which measure PTSD-specific psychosocial function, with a higher score representing a worse outcome.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
- Subjects who have PTSD, diagnosed according to DSM-5, and confirmed by the Mini International Neuropsychiatric Interview (MINI).
- Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.
Exclusion Criteria:
- The index traumatic event that led to the develop of PTSD took place > 9 years before screening.
- The index traumatic event occurred before age 16.
- Subjects who have experienced a traumatic event within 3 months of screening.
- Subjects who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124614
United States, California | |
For additional information regarding sites, contact 844-687-8522 | |
San Diego, California, United States, 92103 |
Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT04124614 |
Other Study ID Numbers: |
331-201-00071 |
First Posted: | October 11, 2019 Key Record Dates |
Last Update Posted: | September 1, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data. |
Access Criteria: | Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com |
URL: | https://clinical-trials.otsuka.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
PTSD |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Sertraline Brexpiprazole Antidepressive Agents Psychotropic Drugs Selective Serotonin Reuptake Inhibitors |
Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Dopamine Agonists Dopamine Agents |