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

Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose study of brexpiprazole as adjunctive treatment to paroxetine or sertraline in adult patients suffering from post-traumatic stress disorder (PTSD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004982-41-EE

Enrollment

790

Registered

2013-10-11

Start date

2013-11-11

Completion date

Unknown

Last updated

2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder (PTSD) MedDRA version: 18.0 Level: PT Classification code 10036316 Term: Post-traumatic stress disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: Brexpiprazole Product Code: Lu AF41156, OPC-34712 Pharmaceutical Form: Tablet INN or Proposed INN: BREXPIPRAZOLE CAS Number: 913611-97-9 Current Sponsor code: Lu-AF41156 Other descriptiv

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: • The index traumatic event that led to development of PTSD took place more than15 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.

Design outcomes

Primary

Measure	Time frame
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 - To evaluate the efficacy of brexpiprazole up to 3 mg/day on sleep quality - To evaluate the efficacy of brexpiprazole up to 3 mg/day on depressive and anxiety symptoms - To evaluate the efficacy of brexpiprazole up to 3 mg/day on functioning - To evaluate the efficacy of brexpiprazole up to 3 mg/day on health-related quality of life - To evaluate the safety and tolerability of up to 3 mg/day brexpiprazole ;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	—

Measure

Time frame

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 - To evaluate the efficacy of brexpiprazole up to 3 mg/day on sleep quality - To evaluate the efficacy of brexpiprazole up to 3 mg/day on depressive and anxiety symptoms - To evaluate the efficacy of brexpiprazole up to 3 mg/day on functioning - To evaluate the efficacy of brexpiprazole up to 3 mg/day on health-related quality of life - To evaluate the safety and tolerability of up to 3 mg/day brexpiprazole ;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

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Secondary

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

Measure

Time frame

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

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Countries

Argentina, Denmark, Estonia, Finland, France, Italy, Mexico, Poland, Serbia, South Africa, Sweden, United States

Contacts

Public ContactLundbeckClinicalTrials@lundbeck.com

H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026