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

NCT01987960 | Terminated Phase 3 Results

• 2 other identifiers: 14865A2012-004982-41
• Study Type: interventional
• Target: 417
• Locations: 8 countries
• Sites: 56

Brief Summary

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

Conditions

Post-traumatic Stress Disorder; PTSD

Outcome Measures

Primary Outcomes (1)

• PTSD Symptoms Using CAPS-2 Total Score

  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.

  Period 2: Baseline to Week 12 (of randomized period)

Secondary Outcomes (1)

• Global Clinical Impression Severity of Illness (CGI-S) Score

  Period 2: Baseline to Week 12 (of randomized period)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER)

Drug: Placebo

Brexpiprazole

EXPERIMENTAL

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

Interventions

Placebo DRUG

Once daily, tablets, orally

Placebo

Brexpiprazole DRUG

1 to 3 mg/day, once daily dose, tablets, orally

Brexpiprazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (59)

US004

Los Angeles, California, 90024, United States

Location

US025

Los Angeles, California, 90102, United States

Location

US024

Riverside, California, 92504, United States

Location

US015

San Diego, California, 90103, United States

Location

US008

San Diego, California, 92123, United States

Location

US002

Bradenton, Florida, 34201, United States

Location

US006

Gainesville, Florida, 32607, United States

Location

US016

Jacksonville, Florida, 32256, United States

Location

US020

North Miami, Florida, 33161, United States

Location

US017

Tampa, Florida, 33609, United States

Location

US012

Indianapolis, Indiana, 46260, United States

Location

US021

Roslindale, Massachusetts, 02131, United States

Location

US019

Las Vegas, Nevada, 89102, United States

Location

US007

Nashua, New Hampshire, 03060, United States

Location

US001

The Bronx, New York, 10467, United States

Location

US009

Cincinnati, Ohio, 45219, United States

Location

US005

Dayton, Ohio, 45417, United States

Location

US010

Portland, Oregon, 97210, United States

Location

US014

Norristown, Pennsylvania, 19403, United States

Location

US011

Memphis, Tennessee, 38119, United States

Location

US003

Austin, Texas, 78731, United States

Location

US026

Seattle, Washington, 98104, United States

Location

EE001

Tallinn, Estonia

Location

FI002

Helsinki, Finland

Location

FI003

Helsinki, Finland

Location

FI001

Kuopio, Finland

Location

FI006

Oulu, Finland

Location

FI005

Tampere, Finland

Location

FI004

Turku, Finland

Location

FR002

Fort de France, France

Location

FR003

Laxou, France

Location

FR004

Nîmes, France

Location

FR005

Thuir, France

Location

FR001

Tours, France

Location

IT005

Andria, Italy

Location

IT004

Catania, Italy

Location

IT003

Lecce, Italy

Location

IT001

Pisa, Italy

Location

IT002

Siena, Italy

Location

PL003

Bialystok, Poland

Location

PL004

Gdansk, Poland

Location

PL005

Gdansk, Poland

Location

PL001

Leszno, Poland

Location

PL002

Lublin, Poland

Location

RS006

Belgrade, Serbia

Location

RS004

Niš, Serbia

Location

RS005

Novi Kneževac, Serbia

Location

ZA006

Bloemfontein, South Africa

Location

ZA002

Cape Town, South Africa

Location

ZA003

Cape Town, South Africa

Location

ZA004

Cape Town, South Africa

Location

ZA005

Cape Town, South Africa

Location

ZA008

Durban, South Africa

Location

ZA007

Port Elizabeth, South Africa

Location

ZA001

Pretoria, South Africa

Location

ZA009

Pretoria, South Africa

Location

SE001

Falun, Sweden

Location

SE002

Stockholm, Sweden

Location

SE003

Uppsala, Sweden

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

As the study was terminated limited efficacy and safety data were collected from the randomized patients. The data are descriptive and the primary and key secondary efficacy analyses were not done.

Results Point of Contact

• Title: H. Lundbeck
• Organization: A/S

LundbeckClinicalTrials@Lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 13, 2017
• Results First Posted: March 13, 2017

Record last verified: 2017-01

Locations

US (22); FI (6); SE (3); IT (5); PL (5); FR (5); ZA (9); ES (1)