Brief Summary
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.
Brief Title
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Post-traumatic Stress Disorder
PTSD
Eligibility 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.
* 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.
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 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.
inclusion and
* 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.
inclusion and
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT01987960
Org Class
Industry
Org Full Name
H. Lundbeck A/S
Org Study Id
14865A
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
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.
Outcome Measure
PTSD Symptoms Using CAPS-2 Total Score
Outcome Time Frame
Period 2: Baseline to Week 12 (of randomized period)
Secondary Ids
Secondary Id
2012-004982-41
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
Period 2: Baseline to Week 12 (of randomized period)
Outcome Measure
Global Clinical Impression Severity of Illness (CGI-S) Score
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Eric Hollander
Investigator Email
eholland@montefiore.org
Investigator Phone
718-920-4287