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CompletedPhase 4ACTRN12610000954022

An open randomised clinical trial involving Haloperidol, Olanzapine, Quetiapine, Risperidone, and Ziprasidone in first episode never-treated psychosis

Antipsychotic discontinuation in first-episode never-treated psychosis: an open randomised clinical trial involving Haloperidol, Olanzapine, Quetiapine, Risperidone, and Ziprasidone

Sponsor

Lilly

Enrollment

150 participants

Start Date

Jan 1, 2002

Study Type

Interventional

Conditions

Antipsychotic discontinuation in first episode psychosis

Summary

The goal of this study was to perform a pragmatic, open, randomized clinical trial comparing the 12-month effectiveness (measured by time to discontinuation) of several second-generation antipsychotic drugs, with that of low doses of haloperidol in never-treated FEP. Method: 150 patients were randomized to open-label antipsychotic treatment with haloperidol, olanzapine, risperidone, quetiapine, and ziprasidone. Retention of patients on treatment was considered a measure for effectiveness (primary outcome measure). Secondary outcomes included symptom change by antipsychotic as measured by the Positive and Negative Syndrome Scale (PANSS).

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares five different antipsychotic medications in people experiencing their first episode of psychosis who have never been treated before. Participants must be 18 or older and showing significant psychotic symptoms. People with major medical or neurological conditions, intellectual disability, or substance-induced symptoms are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients were randomized to open-label antipsychotic treatment with the following dose ranges: olanzapine 7.5-40 mg/day, risperidone 1.5-7.0 mg/day, quetiapine 100–1500 mg/day, and ziprasidone 40–240

Patients were randomized to open-label antipsychotic treatment with the following dose ranges: olanzapine 7.5-40 mg/day, risperidone 1.5-7.0 mg/day, quetiapine 100–1500 mg/day, and ziprasidone 40–240 mg/day. Study medication was administered orally with the doses prescribed at the treating psychiatrist's discretion. Participants randomized to each second generation antipsychotic received the assigned antipsychotic for 12 months on a daily basis.

Locations(1)

Barcelona, Spain

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ACTRN12610000954022