Schizophrenia Clinical Trial
— GiSASOfficial title:
GiSAS Trial: Aripiprazole, Olanzapine, and Haloperidol in the Long Term Treatment of Schizophrenia.
The GiSAS study is a multi-centre randomized clinical trial that will involve about 80
italian community psychiatric services in Italy and will recruit 800 patients affected by
schizophrenia.
In a sample of schizophrenic outpatients, it is hypothesized that there are significant
differences in the overall tolerability and effectiveness of aripiprazole, olanzapine and
haloperidol at 12 months.
It is a pragmatic trial. Thus, participants are selected to represent a broad range of
"real-world" patients, all treatment medications are non-blinded and after randomization,
the assigned drugs will be prescribed according to usual care practice.
The measure for effectiveness is retention of patients on the assigned treatment. The
measure for tolerability is the onset of metabolic syndrome.
Status | Completed |
Enrollment | 300 |
Est. completion date | June 2013 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - men and women, 18 years of age and over, who meet DSM-IV criteria for schizophrenia, based upon the Mini International Neuropsychiatric Interview; - patients entering the study must, according to their own judgment in consultation with their physician, have a condition appropriate for (a) starting treatment with an oral antipsychotic medication or (b) changing antipsychotic treatment. Exclusion Criteria: - diagnosis of metabolic syndrome, defined as the fulfilling of at least 3 of the diagnostic criteria for the metabolic syndrome derived from Adult Treatment Protocol III (ATP III); - diagnosis of diabetes mellitus type II; - presence of an organic condition clearly contraindicating treatment with one of the studied drugs, e.g., pregnancy or breast-feeding; - one of the studied treatments is positively known to be ineffective or not tolerable and consequently contraindicated; - the patient has never been exposed to antipsychotic drugs; - according to clinician's opinion, it is unlikely that the patient can be followed for the whole duration of the study (1 year). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Department of Mental Health | Genoa | Liguria |
Lead Sponsor | Collaborator |
---|---|
Mario Negri Institute for Pharmacological Research | Bristol-Myers Squibb |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The measure for tolerability is the onset of metabolic syndrome as defined by meeting at least 3 of the following criteria: (1) abdominal obesity, (2) high triglycerides, (3) high HDL, (4) high blood pressure and (5) hyperglycaemia. | 12 months | Yes | |
Secondary | The primary measure for effectiveness is retention of patients on the assigned treatment at 12 months. Switching to another antipsychotic, adding a second antipsychotic or stopping antipsychotic treatment will be considered as drug discontinuation. | The trial takes account of two main outcomes, one for tolerability and one for effectiveness. Together, in fact, they must provide the most clinically relevant and convincing evidence directly related to the primary objective of the trial. The proportion of subjects who developed MS at one year was compared between the study groups and was adopted as primary endpoint. However, as the study design and conduction were focused on the one-year retention of the allocated monotherapy, the study power was estimated for this secondary endpoint too | 12 months | No |
Secondary | Global functioning and symptomatology (GAF) | 12 months. | No | |
Secondary | Time to discontinuation due to efficacy | 12 months. | No | |
Secondary | Time to discontinuation due to side effects | 12 months | No | |
Secondary | Worsening of metabolic profile | Defined as the onset of at least one metabolic syndrome criterion; onset of serum lipids abnormalities (dyslipidemia) | 12 months | No |
Secondary | Neuroleptic side effects' self-rating (LUNSERS) | 12 months | No |
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