Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT01987960|
Recruitment Status : Terminated (The study was terminated due to challenges with patient eligibility; the decision to terminate was not based on any safety concerns)
First Posted : November 20, 2013
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic Stress Disorder PTSD||Drug: Placebo Drug: Brexpiprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||417 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Placebo Comparator: Placebo
Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)
Once daily, tablets, orally
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.
1 to 3 mg/day, once daily dose, tablets, orally
- PTSD Symptoms Using CAPS-2 Total Score [ Time Frame: 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.
- Global Clinical Impression Severity of Illness (CGI-S) Score [ Time Frame: 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).
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): NCT01987960
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|