Brexpiprazole in patients with schizophrenia
- Conditions
- SchizophreniaMedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-002705-21-CZ
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 137
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method