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Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia (GiSAS)
This study has been completed.
Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT01052389
First received: January 18, 2010
Last updated: April 9, 2014
Last verified: April 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: Aripiprazole Drug: Olanzapine Drug: Haloperidol | Phase 4 |
| Study Type: | Interventional |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Haloperidol
Haloperidol decanoate
Aripiprazole
Olanzapine
Olanzapine pamoate
U.S. FDA Resources
Further study details as provided by Mario Negri Institute for Pharmacological Research:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 300 |
| Study Start Date: | July 2007 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aripiprazole
Aripiprazole (N05AX12)
|
Drug: Aripiprazole
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
|
|
Experimental: Olanzapine
Olanzapine (N05AH03)
|
Drug: Olanzapine
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
|
|
Experimental: Haloperidol
Haloperidol (N05AD01)
|
Drug: Haloperidol
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01052389
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052389
Locations
| Italy | |
| Department of Mental Health | |
| Genoa, Liguria, Italy, 16125 | |
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Bristol-Myers Squibb
Investigators
| 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 |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mario Negri Institute for Pharmacological Research |
| ClinicalTrials.gov Identifier: | NCT01052389 History of Changes |
| Other Study ID Numbers: |
GiSAS 001 2007-000278-22 ( EudraCT Number ) |
| Study First Received: | January 18, 2010 |
| Last Updated: | April 9, 2014 |
Keywords provided by Mario Negri Institute for Pharmacological Research:
|
Schizophrenia Pragmatic RCT Aripiprazole Olanzapine |
Haloperidol Metabolic syndrome Drug discontinuation |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Haloperidol Olanzapine Haloperidol decanoate Aripiprazole Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Serotonin Agents |
ClinicalTrials.gov processed this record on June 23, 2017