Status:
COMPLETED
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disord...
Eligibility Criteria
Inclusion
- Main
- The patient has schizophrenia, diagnosed according to DSM-IV-TR®.
- The patient has a CGI-S score from mildly ill to markedly ill at the Screening and Baseline Visit(s).
- The patient is in need of a change in the current antipsychotic treatment and in the judgement of the investigator the patient would benefit from an extended treatment with a once-monthly formulation.
- The patient agrees to protocol-defined use of effective contraception.
- Main
Exclusion
- The patient has any current psychiatric disorder or Axis I disorder (DSM-IV® criteria) other than schizophrenia established as the primary diagnosis.
- The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the Screening and Baseline Visits.
- The patient in the investigator's judgment has shown significant intolerance and/or lack of efficacy to oral aripiprazole, paliperidone or risperidone.
- The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
- The patient has a history of neuroleptic malignant syndrome.
- The patient has or has had significant medical condition that would expose him or her to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the study including, but not limited to neurological, hepatic, renal, metabolic, haematological, immunological, gastrointestinal, pulmonary, or cardiovascular disorders.
- The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
- The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT01795547
Start Date
February 1 2013
End Date
September 1 2014
Last Update
March 17 2017
Active Locations (2)
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1
US002
Los Angeles, California, United States, 90660
2
US006
San Diego, California, United States, 92102