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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00932529
Acronym
BPP
Enrollment
226
Registered
2009-07-03
Start date
2003-02-28
Completion date
2010-01-31
Last updated
2010-05-25

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

Conditions

Psychotic Disorders

Keywords

Antipsychotic drugs, Treatment effectiveness, Randomized controlled trial

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.

Interventions

DRUGOlanzapine

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

DRUGQuetiapine

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

DRUGRisperidone

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

DRUGZiprasidone

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

Sponsors

University of Bergen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction of PANSS total scoreAdmission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.

Secondary

MeasureTime frame
TolerabilityDischarge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge
Time until initial drug discontinuationUp to 24 months follow-up

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026