Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Status: | Completed |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 4/21/2016 |
Start Date: | February 2013 |
End Date: | September 2014 |
A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
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 Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care
setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.
patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical
Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care
setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.
Main Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
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