Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia (GiSAS)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||GiSAS Trial: Aripiprazole, Olanzapine, and Haloperidol in the Long Term Treatment of Schizophrenia.|
- 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. [ Time Frame: 12 months ]
- 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. [ Time Frame: 12 months ]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
- Global functioning and symptomatology (GAF) [ Time Frame: 12 months. ]
- Time to discontinuation due to efficacy [ Time Frame: 12 months. ]
- Time to discontinuation due to side effects [ Time Frame: 12 months ]
- Worsening of metabolic profile [ Time Frame: 12 months ]Defined as the onset of at least one metabolic syndrome criterion; onset of serum lipids abnormalities (dyslipidemia)
- Neuroleptic side effects' self-rating (LUNSERS) [ Time Frame: 12 months ]
|Study Start Date:||July 2007|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Patients allocated to aripiprazole will be prescribed daily oral dose of drug, based on individual response and side-effects. Suggested starting dose will be 10 mg/day and dose range will be 10-30 mg/day.
Other Name: ATC code: N05AX12
Patients allocated to olanzapine will be prescribed daily oral dose of drug, based on individual patients' response and side-effect burden. Suggested starting dose will be 5 mg/day and dose range will be 10-20 mg/day.
Other Name: ATC code: N05AH03
Patients allocated to haloperidol FGA arm will be prescribed daily oral dose of drug, based on individual patients' response and side-effect burden.
Suggested starting dose will be 1-3 mg/day and dose range 3-10 mg/day (chlorpromazine equivalents: suggested starting dose 50-100 mg/day; dose range 150-300 mg/day).
Other Name: ATC code: N05AD01
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052389
|Department of Mental Health|
|Genoa, Liguria, Italy, 16125|
|Principal Investigator:||Angelo Barbato, M.D.||'Mario Negri' Institute for Pharmacological Research|
|Study Director:||Alberto Parabiaghi, M.D.||'Mario Negri' Institute for Pharmacological Research|
|Study Chair:||Barbara D'Avanzo, Phil.D.||'Mario Negri' Institute for Pharmacological Research|
|Study Chair:||Mauro Tettamanti, Biol.D.||'Mario Negri' Institute for Pharmacological Research|