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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000954022

Enrollment

150

Registered

2010-11-08

Start date

2002-01-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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).

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results