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

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ClinicalTrials.gov Identifier: NCT00932529
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : May 25, 2010
Sponsor:
Information provided by:
University of Bergen

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Drug: Olanzapine Drug: Quetiapine Drug: Risperidone Drug: Ziprasidone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting.
Study Start Date : February 2003
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Olanzapine Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa

Drug: Quetiapine
Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.
Other Name: Seroquel

Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon

Active Comparator: Quetiapine Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa

Drug: Risperidone
Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.
Other Name: Risperdal

Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon

Active Comparator: Risperidone Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa

Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon

Active Comparator: Ziprasidone Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa

Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon




Primary Outcome Measures :
  1. Reduction of PANSS total score [ Time Frame: Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance. ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932529


Locations
Norway
Haukeland University Hospital, Division of Psychiatry
Bergen, Sandviken, Norway, N-5035
Sponsors and Collaborators
University of Bergen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hugo A. Jørgensen, University of Bergen
ClinicalTrials.gov Identifier: NCT00932529     History of Changes
Other Study ID Numbers: NSD-ID10591
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: May 25, 2010
Last Verified: December 2003

Keywords provided by University of Bergen:
Antipsychotic drugs
Treatment effectiveness
Randomized controlled trial

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Risperidone
Ziprasidone
Antipsychotic Agents
Olanzapine
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators