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NCT Number: NCT00932529

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haukeland University Hospital, Division of Psychiatry

Bergen, Sandviken, N-5035, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

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

Other names: Zyprexa

Quetiapine

Drug

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

Other names: Seroquel

Risperidone

Drug

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

Other names: Risperdal

Ziprasidone

Drug

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

Other names: Zeldox, Geodon

Primary outcomes

  1. Reduction of PANSS total score

    Time frame: Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.

Secondary outcomes

  1. Tolerability

    Time frame: Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge

  2. Time until initial drug discontinuation

    Time frame: Up to 24 months follow-up

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

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

Acronym: BPP

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Jul 3, 2009
Registry last updated
May 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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