Brexpiprazole in patients with schizophrenia

Conditions: Schizophrenia
MedDRA version: 17.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2012-002705-21-PL

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

• 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

Exclusion Criteria

• 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
Main Objective: -Long-term safety and tolerability of brexpiprazole;Secondary Objective: - Effect of brexpiprazole in patients with schizophrenia on psychotic symptoms<br>- Effect of brexpiprazole in patients with schizophrenia on global clinical impression<br>- Effect of brexpiprazole in patients with schizophrenia on response rate<br>- Effect of brexpiprazole in patients with schizophrenia on personal and social performance<br>;Primary end point(s): -Safety and tolerability<br>-Risk of suicidality;Timepoint(s) of evaluation of this end point: -Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP).<br>-Up to 52 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Change from baseline in psychotic symptoms (Positive and Negative Syndrome Scale (PANSS) total score)<br>-Change from baseline in psychotic symptoms (PANSS Positive Subscale score)<br>-Change from baseline in psychotic symptoms (PANSS Negative Subscale score)<br>-Change from baseline in psychotic symptoms (PANSS Excited Component score)<br>-Change from baseline in psychotic symptoms (PANSS Marder score)<br>-Change from baseline in clinical global impression<br>-Improvement of clinical global impression<br>-Response rate<br>-Change from baseline in personal and social performance<br>;Timepoint(s) of evaluation of this end point: -Baseline and Week 52<br>-Baseline and Week 52<br>-Baseline and Week 52<br>-Baseline and Week 52<br>-Baseline and Week 52<br>-Baseline and Week 52<br>-Week 52<br>-Baseline and Week 52<br>-Baseline and Week 52