Brexpiprazole as an additional treatment to paroxetine or sertraline in adult patients suffering from post-traumatic stress disorder (PTSD)

Conditions: Post-traumatic stress disorder (PTSD)
MedDRA version: 16.1Level: PTClassification code 10036316Term: Post-traumatic stress disorderSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2012-004982-41-IT

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 790

Inclusion Criteria

• The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
• The patient has a pre-defined Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score at Screening and Baseline Visits.
• The reported duration of the PTSD is at least 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 790
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• The index traumatic event that led to development of PTSD took place more than 15 years before screening.
• The patient has a severe personality disorder that in the investigator's opinion may
interfere with the conduct of the study.
• The patient is at significant suicidal risk.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of brexpiprazole up to 3 mg/day as adjunctive treatment to paroxetine or sertraline on PTSD symptoms;Secondary Objective: - To evaluate the efficacy of brexpiprazole up to 3 mg/day on global clinical impression<br>- To evaluate the efficacy of brexpiprazole up to 3 mg/day on sleep quality<br>- To evaluate the efficacy of brexpiprazole up to 3 mg/day on depressive and anxiety symptoms<br>- To evaluate the efficacy of brexpiprazole up to 3 mg/day on functioning<br>- To evaluate the efficacy of brexpiprazole up to 3 mg/day on health-related quality of life<br>- To evaluate the safety and tolerability of up to 3 mg/day brexpiprazole<br>;Primary end point(s): Change from randomisation in PTSD symptoms using CAPS-2 total score;Timepoint(s) of evaluation of this end point: Baseline and Week 28

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change from randomisation in global clinical impression using CGI-S score<br>- Change from randomisation in functioning using SDS score<br>- Safety - number of adverse events<br>- Tolerability - number of withdrawals<br>;Timepoint(s) of evaluation of this end point: - Change from randomisation in global clinical impression using CGI-S score -Time Frame: Baseline and Week 28 <br>- Change from randomisation in functioning using SDS score -Time Frame:Baseline and Week 28 <br>- Safety - number of adverse events-Time Frame:Up to 28 weeks and a 30-day telephone contact or clinic visit<br>- Tolerability - number of withdrawals - Time Frame:Up to 28 weeks<br>Up to 28 weeks and a 30-day telephone contact or<br>clinic visit