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Status:

COMPLETED

Brexpiprazole in Patients With Acute Schizophrenia

Lead Sponsor:

H. Lundbeck A/S

Collaborating Sponsors:

Otsuka Pharmaceutical Co., Ltd.

Conditions:

Schizophrenia

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2014

Estimated Enrollment :

468 Patients enrolled

Trial Details

Trial ID

NCT01810380

Start Date

March 1 2013

End Date

December 1 2014

Last Update

March 16 2017

Active Locations (1)

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1

US009

Escondido, California, United States, 92025