Brexpiprazole in patients with acute schizophrenia

• Conditions: Schizophrenia; MedDRA version: 15.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-002252-17-SK
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-04
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and
confirmed by the Mini International Neuropsychiatric Interview (MINI).
•
The patient has an acute exacerbation of psychotic symptoms and marked
deterioration of usual function.
•
The patient is willing to be hospitalised from the Screening Visit through
Week 6.
•
The patient will benefit from hospitalisation or continued hospitalisation for
treatment of a current acute relapse of schizophrenia at study entry.
•
The patient has a history of relapse and/or exacerbation of symptoms when
not receiving antipsychotic treatment, excluding the current episode.
•
• 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 455
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other
than schizophrenia established as primary diagnosis.
•
The patient suffers from a current Axis II diagnosis (DSM-IV-TR™
criteria).
•
The patient suffers from mental retardation, organic mental disorders, or
mental disorders due to a general medical condition (DSM-IV-TR™
criteria).
•
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 clinically significant tardive dyskinesia or severe akathisia
at enrolment.
•
• The patient has a history of neuroleptic malignant syndrome.
The patient has any relevant medical history or current presence of systemic
disease.
•
The patient has, at the Screening Visit an abnormal ECG or other abnormal
ECG tests that are, in the investigator's opinion, clinically significant.
•
The patient has a history of cancer, other than basal cell or Stage 1
squamous cell carcinoma of the skin, that has not been in remission for >5
years prior to the first dose of brexpiprazole.
•
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: -Efficacy of brexpiprazole versus placebo on the treatment of acute schizophrenia;Secondary Objective: - Efficacy of brexpiprazole versus placebo on global clinical impression<br>- Efficacy of brexpiprazole versus placebo on psychotic symptoms<br>- Efficacy of brexpiprazole versus placebo on response rate<br>- Efficacy of brexpiprazole versus placebo on personal and social performance<br>;Primary end point(s): Change from baseline in efficacy using PANSS;Timepoint(s) of evaluation of this end point: Baseline and Week 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Change from baseline in clinical global impression<br>-Improvement of clinical global impression<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 Factor scores)<br>-Response rate<br>-Change from baseline in personal and social performance<br>-Safety and tolerability<br>-Risk of suicidality;Timepoint(s) of evaluation of this end point: -Baseline and Week 6<br>-Week 6<br>-Baseline and Week 6<br>-Baseline and Week 6<br>-Baseline and Week 6<br>-Baseline and Week 6<br>-Baseline and Week 6<br>-Baseline and Week 6<br>-Up to 6 weeks and a safety follow-up by telephone contact<br>or clinic visit after 30 days after the last dose of<br>investigational medicinal product (IMP) for patients who do<br>not enter the follow-up study 14644B<br>-Up to 6 weeks