Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

Phase 3

Terminated

• Conditions: Post-traumatic Stress Disorder; PTSD
• Interventions: Drug: Placebo; Drug: Brexpiprazole

• Registration Number: NCT01987960
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Study Start: 2013-12
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-10-28
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-23
• Last Update Submitted: 2017-01-23
• Results First Posted: 2017-03-13
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 417

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 Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score ≥70 at Screening and Baseline Visits.
• The reported duration of the PTSD is at least 3 months.

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.

Other inclusion and exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)
Brexpiprazole	Brexpiprazole	Brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day.

Primary Outcome Measures

Name	Time	Method
PTSD Symptoms Using CAPS-2 Total Score	Period 2: Baseline to Week 12 (of randomized period)	Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.

Secondary Outcome Measures

Name	Time	Method
Global Clinical Impression Severity of Illness (CGI-S) Score	Period 2: Baseline to Week 12 (of randomized period)	Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).

Trial Locations

Locations (59)

US004; 🇺🇸 Los Angeles, California, United States

US025; 🇺🇸 Los Angeles, California, United States

US024; 🇺🇸 Riverside, California, United States

US015; 🇺🇸 San Diego, California, United States

US008; 🇺🇸 San Diego, California, United States

US002; 🇺🇸 Bradenton, Florida, United States

US006; 🇺🇸 Gainesville, Florida, United States

US016; 🇺🇸 Jacksonville, Florida, United States

US020; 🇺🇸 North Miami, Florida, United States

US017; 🇺🇸 Tampa, Florida, United States

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