NCT00932529

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: University of Bergen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2003-02-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-07-03
• Last updated: 2010-05-25

Locations

1 site across 1 country: Norway