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

NCT00932529 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2010-05-25

No results posted yet for this study

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.

Conditions

  • Psychotic Disorders

Interventions

DRUG

Olanzapine

Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion

DRUG

Quetiapine

Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.

DRUG

Risperidone

Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.

DRUG

Ziprasidone

Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion

Sponsors & Collaborators

  • University of Bergen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00932529 on ClinicalTrials.gov