Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
- Conditions
- Post-traumatic Stress DisorderPTSD
- Interventions
- Drug: PlaceboDrug: 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 417
- 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.
- 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)
PL002
🇵🇱Lublin, Poland
FI004
🇫🇮Turku, Finland
FI002
🇫🇮Helsinki, Finland
IT002
🇮🇹Siena, Italy
US003
🇺🇸Austin, Texas, United States
FI003
🇫🇮Helsinki, Finland
FI005
🇫🇮Tampere, Finland
FR001
🇫🇷Tours Cedex 9, France
PL005
🇵🇱Gdansk, Poland
PL003
🇵🇱Bialystok, Poland
PL001
🇵🇱Leszno, Poland
US016
🇺🇸Jacksonville, Florida, United States
US014
🇺🇸Norristown, Pennsylvania, United States
RS005
🇷🇸Novi Knezevac, Serbia
ZA003
🇿🇦Cape Town, South Africa
RS004
🇷🇸Nis, Serbia
ZA006
🇿🇦Bloemfontein, South Africa
US021
🇺🇸Roslindale, Massachusetts, United States
SE002
🇸🇪Stockholm, Sweden
ZA007
🇿🇦Port Elizabeth, South Africa
FI001
🇫🇮Kuopio, Finland
FI006
🇫🇮Oulu, Finland
FR003
🇫🇷Laxou, France
US011
🇺🇸Memphis, Tennessee, United States
EE001
🇪🇪Tallinn, Estonia
IT005
🇮🇹Andria, Italy
IT003
🇮🇹Lecce, Italy
IT001
🇮🇹Pisa, Italy
SE003
🇸🇪Uppsala, Sweden
FR002
🇫🇷Fort de France, France
FR005
🇫🇷Thuir Cedex, France
ZA004
🇿🇦Cape Town, South Africa
US017
🇺🇸Tampa, Florida, United States
US001
🇺🇸Bronx, New York, United States
US005
🇺🇸Dayton, Ohio, United States
IT004
🇮🇹Catania, Italy
US007
🇺🇸Nashua, New Hampshire, United States
US020
🇺🇸North Miami, Florida, United States
FR004
🇫🇷Nimes Cedex 9, France
RS006
🇷🇸Belgrade, Serbia
ZA002
🇿🇦Cape Town, South Africa
ZA001
🇿🇦Pretoria, South Africa
ZA005
🇿🇦Cape Town, South Africa
ZA008
🇿🇦Durban, South Africa
SE001
🇸🇪Falun, Sweden
ZA009
🇿🇦Pretoria, South Africa
PL004
🇵🇱Gdansk, Poland
US004
🇺🇸Los Angeles, California, United States
US002
🇺🇸Bradenton, Florida, United States
US006
🇺🇸Gainesville, Florida, 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
US012
🇺🇸Indianapolis, Indiana, United States
US019
🇺🇸Las Vegas, Nevada, United States
US009
🇺🇸Cincinnati, Ohio, United States
US010
🇺🇸Portland, Oregon, United States
US026
🇺🇸Seattle, Washington, United States