Brexpiprazole in Patients With Acute Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | March 2013 |
| End Date: | December 2014 |
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia
To determine the efficacy and safety of brexpiprazole for the treatment of adults
experiencing an acute episode of schizophrenia.
experiencing an acute episode of schizophrenia.
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.
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.
Other inclusion and exclusion criteria may apply.
We found this trial at
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