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
Lilly
150 participants
Jan 1, 2002
Interventional
Conditions
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
Inclusion Criteria2
- Showing psychotic symptoms at admission (having a score of 4 or more on PANSS positive scale items 1, 3, 5, or 6) and being naive of antipsychotic, antidepressant or mood stabilizer treatment.
- Signing a consent document
Exclusion Criteria1
- Presence of a major medical or neurological disease, mental retardation, suspicion of substance use directly contributing to the emergence of symptoms (not merely a comorbid condition) and previous treatment with psychotropic drugs.
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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 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)
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ACTRN12610000954022