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

Psychotic Disorders Clinical Trial

— BPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932529
• Other study ID #: NSD-ID10591
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2009
• Last updated: May 24, 2010
• Start date: February 2003
• Est. completion date: January 2010

Study information

• Verified date: December 2003
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
• Quetiapine
Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.
• Risperidone
Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.
• Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion

Locations

Country	Name	City	State
Norway	Haukeland University Hospital, Division of Psychiatry	Bergen	Sandviken

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of PANSS total score		Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.	No
Secondary	Tolerability		Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge	Yes
Secondary	Time until initial drug discontinuation		Up to 24 months follow-up	Yes