GiSAS trial aripiprazole, olanzapine and haloperidol in the long term treatment of schizophrenia. - GiSAS trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000278-22-IT

Enrollment

800

Registered

2007-04-03

Start date

2007-03-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia MedDRA version: 6.1 Level: SOC Classification code 10037175

Interventions

Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 years of age or over; 2. DSM-IV diagnosis of schizophrenia MINI ; 3. Patients must have a condition appropriate for changing the oral antipsychotic treatment or starting a new one. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Diagnosis of metabolic syndrome; 2. diagnosis of diabetes mellitus type II; 3. at least one of the studied treatments is clearly controindicated; 4. the patient has never been exposed to antipsychotic drugs.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the onset of metabolic syndrome over a 12-months period in patients with schizophrenia treated with aripiprazole, olanzapine and haloperidol.;Secondary Objective: To evaluate effectiveness and tolerability of aripiprazole, olanzapine and haloperidol in patients with schizophrenia over a 12-month period.;Primary end point(s): 1. Onset of metabolic syndrome; 2. discontinuation of treatment for any reason.	—

Measure

Time frame

Main Objective: To evaluate the onset of metabolic syndrome over a 12-months period in patients with schizophrenia treated with aripiprazole, olanzapine and haloperidol.;Secondary Objective: To evaluate effectiveness and tolerability of aripiprazole, olanzapine and haloperidol in patients with schizophrenia over a 12-month period.;Primary end point(s): 1. Onset of metabolic syndrome; 2. discontinuation of treatment for any reason.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026