Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting

Phase 4

Completed

• Conditions: Psychotic Disorders
• Interventions: Drug: Olanzapine; Drug: Quetiapine; Drug: Risperidone; Drug: Ziprasidone

• Registration Number: NCT00932529
• Lead Sponsor: University of Bergen

Brief Summary

Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Status Verified: 2003-12
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-05-24
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• Psychosis
• Must be able to use oral antipsychotic drugs

Exclusion Criteria

• Mania
• Unable to cooperate with the assessments
• Unable to understand Norwegian language
• Candidates for electroconvulsive therapy
• Use of Clozapine at admittance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine	Quetiapine	-
Olanzapine	Olanzapine	-
Olanzapine	Ziprasidone	-
Quetiapine	Risperidone	-
Quetiapine	Olanzapine	-
Quetiapine	Ziprasidone	-
Risperidone	Olanzapine	-
Risperidone	Ziprasidone	-
Ziprasidone	Ziprasidone	-
Ziprasidone	Olanzapine	-

Primary Outcome Measures

Name	Time	Method
Reduction of PANSS total score	Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.

Secondary Outcome Measures

Name	Time	Method
Tolerability	Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge
Time until initial drug discontinuation	Up to 24 months follow-up

Trial Locations

Locations (1)

Haukeland University Hospital, Division of Psychiatry; 🇳🇴 Bergen, Sandviken, Norway