Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia (GiSAS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Mario Negri Institute for Pharmacological Research.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborator:
Bristol-Myers Squibb
Information provided by:
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT01052389
First received: January 18, 2010
Last updated: January 19, 2010
Last verified: January 2010
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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 Endpoint Classification: Safety/Efficacy Study 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:
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 ] [ Designated as safety issue: Yes ]
- The 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Global functioning (GAF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Time to discontinuation due to side effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Worsening of metabolic profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Neuroleptic side effects' self-rating (LUNSERS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 800 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aripiprazole
Aripiprazole
|
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.
|
| Experimental: Olanzapine |
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.
|
| Experimental: Haloperidol |
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). |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052389
Contacts
| Contact: Alberto Parabiaghi, M.D. | +39 02 39014431 | parabiaghi@marionegri.it |
| Contact: Barbara D'Avanzo, Phil.D. | +39 02 39014520 | barbara@marionegri.it |
Locations
| Italy | |
| Department of Mental Health | Recruiting |
| Genoa, Liguria, Italy, 16125 | |
| Contact: Marco Vaggi, MD +39 010 6449260 marco.vaggi@asl3.liguria.it | |
| Principal Investigator: Luigi Ferrannini, M.D. | |
| Principal Investigator: Maurizio Marcenaro, M.D. | |
| Sub-Investigator: Marco Vaggi | |
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:
No publications provided by Mario Negri Institute for Pharmacological Research
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Angelo Barbato, Mario Negri Institute for Pharmacological Research, Italy |
| ClinicalTrials.gov Identifier: | NCT01052389 History of Changes |
| Other Study ID Numbers: | GiSAS 001, 2007-000278-22 |
| Study First Received: | January 18, 2010 |
| Last Updated: | January 19, 2010 |
| Health Authority: | Italy: The Italian Medicines Agency European Union: European Medicines Agency |
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 and Disorders with Psychotic Features Mental Disorders Haloperidol Olanzapine Haloperidol decanoate Aripiprazole Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
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 Serotonin Agents |
ClinicalTrials.gov processed this record on May 19, 2013