Clinical trial NCT01987960: Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Post-traumatic Stress Disorder
PTSD
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-11-20
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: PTSD Symptoms Using CAPS-2 Total Score
timeFrame: Period 2: Baseline to Week 12 (of randomized period)
Secondary outcomes:
measure: Global Clinical Impression Severity of Illness (CGI-S) Score
timeFrame: Period 2: Baseline to Week 12 (of randomized period)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: US004
state: California
city: Los Angeles
country: United States
facility: US025
state: California
city: Riverside
country: United States
facility: US024
state: California
city: San Diego
country: United States
facility: US015
state: California
city: San Diego
country: United States
facility: US008
state: California
city: Bradenton
country: United States
facility: US002
state: Florida
city: Gainesville
country: United States
facility: US006
state: Florida
city: Jacksonville
country: United States
facility: US016
state: Florida
city: North Miami
country: United States
facility: US020
state: Florida
city: Tampa
country: United States
facility: US017
state: Florida
city: Indianapolis
country: United States
facility: US012
state: Indiana
city: Roslindale
country: United States
facility: US021
state: Massachusetts
city: Las Vegas
country: United States
facility: US019
state: Nevada
city: Nashua
country: United States
facility: US007
state: New Hampshire
city: Bronx
country: United States
facility: US001
state: New York
city: Cincinnati
country: United States
facility: US009
state: Ohio
city: Dayton
country: United States
facility: US005
state: Ohio
city: Portland
country: United States
facility: US010
state: Oregon
city: Norristown
country: United States
facility: US014
state: Pennsylvania
city: Memphis
country: United States
facility: US011
state: Tennessee
city: Austin
country: United States
facility: US003
state: Texas
city: Seattle
country: United States
facility: US026
state: Washington
city: Tallinn
country: Estonia
facility: EE001
city: Helsinki
country: Finland
facility: FI002
city: Helsinki
country: Finland
facility: FI003
city: Kuopio
country: Finland
facility: FI001
city: Oulu
country: Finland
facility: FI006
city: Tampere
country: Finland
facility: FI005
city: Turku
country: Finland
facility: FI004
city: Fort de France
country: France
facility: FR002
city: Laxou
country: France
facility: FR003
city: Nimes Cedex 9
country: France
facility: FR004
city: Thuir Cedex
country: France
facility: FR005
city: Tours Cedex 9
country: France
facility: FR001
city: Andria
country: Italy
facility: IT005
city: Catania
country: Italy
facility: IT004
city: Lecce
country: Italy
facility: IT003
city: Pisa
country: Italy
facility: IT001
city: Siena
country: Italy
facility: IT002
city: Bialystok
country: Poland
facility: PL003
city: Gdansk
country: Poland
facility: PL004
city: Gdansk
country: Poland
facility: PL005
city: Leszno
country: Poland
facility: PL001
city: Lublin
country: Poland
facility: PL002
city: Belgrade
country: Serbia
facility: RS006
city: Nis
country: Serbia
facility: RS004
city: Novi Knezevac
country: Serbia
facility: RS005
city: Bloemfontein
country: South Africa
facility: ZA006
city: Cape Town
country: South Africa
facility: ZA002
city: Cape Town
country: South Africa
facility: ZA003
city: Cape Town
country: South Africa
facility: ZA004
city: Cape Town
country: South Africa
facility: ZA005
city: Durban
country: South Africa
facility: ZA008
city: Port Elizabeth
country: South Africa
facility: ZA007
city: Pretoria
country: South Africa
facility: ZA001
city: Pretoria
country: South Africa
facility: ZA009
city: Falun
country: Sweden
facility: SE001
city: Stockholm
country: Sweden
facility: SE002
city: Uppsala
country: Sweden
facility: SE003
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: