Brexpiprazole as an Additional Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

PTSD Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01987960
• Other study ID #: 14865A
• Secondary ID: 2012-004982-41
• Status: Terminated
• Phase: Phase 3
• First received: November 13, 2013
• Last updated: November 6, 2015
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of MedicineUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine or sertraline on PTSD symptoms.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 417
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 pre-defined Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Placebo
Once daily, tablets, orally
• Brexpiprazole
Up to 3 mg/day, once daily dose, tablets, orally

Locations

Country	Name	City	State
Estonia	EE001	Tallinn
Finland	FI002	Helsinki
Finland	FI003	Helsinki
Finland	FI001	Kuopio
Finland	FI006	Oulu
Finland	FI005	Tampere
Finland	FI004	Turku
France	FR002	Fort de France
France	FR003	Laxou
France	FR004	Nimes Cedex 9
France	FR005	Thuir Cedex
France	FR001	Tours Cedex 9
Italy	IT005	Andria
Italy	IT004	Catania
Italy	IT003	Lecce
Italy	IT001	Pisa
Italy	IT002	Siena
Poland	PL003	Bialystok
Poland	PL004	Gdansk
Poland	PL005	Gdansk
Poland	PL001	Leszno
Poland	PL002	Lublin
Serbia	RS006	Belgrade
Serbia	RS004	Nis
Serbia	RS005	Novi Knezevac
South Africa	ZA006	Bloemfontein
South Africa	ZA002	Cape Town
South Africa	ZA003	Cape Town
South Africa	ZA004	Cape Town
South Africa	ZA005	Cape Town
South Africa	ZA008	Durban
South Africa	ZA007	Port Elizabeth
South Africa	ZA001	Pretoria
South Africa	ZA009	Pretoria
Sweden	SE001	Falun
Sweden	SE002	Stockholm
Sweden	SE003	Uppsala
United States	US003	Austin	Texas
United States	US002	Bradenton	Florida
United States	US001	Bronx	New York
United States	US009	Cincinnati	Ohio
United States	US005	Dayton	Ohio
United States	US006	Gainesville	Florida
United States	US012	Indianapolis	Indiana
United States	US016	Jacksonville	Florida
United States	US019	Las Vegas	Nevada
United States	US004	Los Angeles	California
United States	US025	Los Angeles	California
United States	US011	Memphis	Tennessee
United States	US007	Nashua	New Hampshire
United States	US014	Norristown	Pennsylvania
United States	US020	North Miami	Florida
United States	US010	Portland	Oregon
United States	US024	Riverside	California
United States	US021	Roslindale	Massachusetts
United States	US008	San Diego	California
United States	US015	San Diego	California
United States	US026	Seattle	Washington
United States	US017	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Otsuka Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Estonia,  Finland,  France,  Italy,  Poland,  Serbia,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from randomisation in PTSD symptoms using CAPS-2 total score	Clinician-Administered PTSD Scale Part 2 (CAPS-2)	Baseline and Week 28	No
Secondary	Change from randomisation in global clinical impression using CGI-S score	Clinical Global Impression - Severity of Illness (CGI-S)	Baseline and Week 28	No
Secondary	Change from randomisation in functioning using SDS score	Sheehan Disability Scale (SDS)	Baseline and Week 28	No
Secondary	Safety	Number of adverse events	Up to 28 weeks and a 30-day telephone contact or clinic visit	Yes
Secondary	Tolerability	Number of withdrawals	Up to 28 weeks	Yes