Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| 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
|
Sponsor:
H. Lundbeck A/S
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Post-Traumatic Stress Disorder
Drug Information available for:
Brexpiprazole
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: Placebo
Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)
|
Drug: Placebo
Once daily, tablets, orally |
|
Experimental: 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.
|
Drug: Brexpiprazole
1 to 3 mg/day, once daily dose, tablets, orally |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 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.
Information from the National Library of Medicine
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
Locations
Show 59 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT01987960 |
| Other Study ID Numbers: |
14865A 2012-004982-41 ( EudraCT Number ) |
| First Posted: | November 20, 2013 Key Record Dates |
| Results First Posted: | March 13, 2017 |
| Last Update Posted: | March 13, 2017 |
| Last Verified: | January 2017 |
Additional relevant MeSH terms:
|
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Brexpiprazole Serotonin Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Dopamine Agonists Dopamine Agents |