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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Post-traumatic Stress Disorder, PTSD

In brief

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

Key facts

Study ID

NCT01987960

Run by

H. Lundbeck A/S

People needed

417

Starts

2013-12-01

Expected to finish

2015-10-01

Last updated by the study team

2017-03-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• Other inclusion and exclusion criteria may apply.

Where it is running

• US025 — Los Angeles, California, United States
• US024 — Riverside, California, United States
• US015 — San Diego, California, United States
• US008 — San Diego, California, United States
• US002 — Bradenton, Florida, United States
• US006 — Gainesville, Florida, United States
• US016 — Jacksonville, Florida, United States
• US020 — North Miami, Florida, United States
• US017 — Tampa, Florida, United States
• US012 — Indianapolis, Indiana, United States
• US021 — Roslindale, Massachusetts, United States
• US019 — Las Vegas, Nevada, United States
• US007 — Nashua, New Hampshire, United States
• US001 — The Bronx, New York, United States
• US009 — Cincinnati, Ohio, United States
• US005 — Dayton, Ohio, United States
• US010 — Portland, Oregon, United States
• US014 — Norristown, Pennsylvania, United States
• US011 — Memphis, Tennessee, United States
• US003 — Austin, Texas, United States
• US026 — Seattle, Washington, United States
• EE001 — Tallinn, Estonia
• FI002 — Helsinki, Finland
• FI003 — Helsinki, Finland
• US004 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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