Brexpiprazole in Patients With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

To determine the safety and efficacy of brexpiprazole during long-term treatment.

Key facts

Study ID

NCT01810783

Run by

H. Lundbeck A/S

People needed

210

Starts

2013-07-01

Expected to finish

2015-12-01

Last updated by the study team

2017-03-27

Who can join

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

You may qualify if…

• The patient has completed the lead-in study 14644A.
• The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
• The patient agrees to protocol-defined use of effective contraception.

You may not qualify if…

• The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A.
• The patient has a clinically significant unstable illness diagnosed during Study 14644A.
• The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
• The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
• Other inclusion and exclusion criteria may apply.

Where it is running

• US010 — Anaheim, California, United States
• US020 — Cerritos, California, United States
• US009 — Escondido, California, United States
• US022 — Garden Grove, California, United States
• US018 — Long Beach, California, United States
• US011 — San Diego, California, United States
• US021 — Washington D.C., District of Columbia, United States
• US004 — Kissimmee, Florida, United States
• US015 — North Miami, Florida, United States
• US019 — Lake Charles, Louisiana, United States
• US016 — St Louis, Missouri, United States
• US002 — Cedarhurst, New York, United States
• US005 — Charleston, South Carolina, United States
• US003 — Austin, Texas, United States
• US012 — Austin, Texas, United States
• US001 — Dallas, Texas, United States
• US013 — Dallas, Texas, United States
• EE002 — Pärnu, Estonia
• EE001 — Tallinn, Estonia
• PL002 — Choroszcz, Poland
• PL005 — Choroszcz, Poland
• PL004 — Gdansk, Poland
• RO004 — Brasov, Romania
• RO007 — Bucharest, Romania
• RO011 — Bucharest, Romania

Full record on ClinicalTrials.gov

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