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Sponsored by: |
University of Bergen |
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Information provided by: | University of Bergen |
ClinicalTrials.gov Identifier: | NCT00932529 |
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 | Intervention | Phase |
---|---|---|
Psychotic Disorders |
Drug: Olanzapine Drug: Quetiapine Drug: Risperidone Drug: Ziprasidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Use, Effects and Side-Effects of Second-Generation Antipsychotics in a Naturalistic Setting. |
Enrollment: | 226 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Olanzapine: Active Comparator |
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: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
|
Quetiapine: Active Comparator |
Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once 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
|
Risperidone: Active Comparator |
Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
|
Ziprasidone: Active Comparator |
Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Bergen ( Hugo A. Jørgensen ) |
Study ID Numbers: | NSD-ID10591 |
Study First Received: | July 2, 2009 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00932529 History of Changes |
Health Authority: | Norway: Norwegian Social Science Data Services |
Antipsychotic drugs Treatment effectiveness Randomized controlled trial |
Neurotransmitter Agents Tranquilizing Agents Olanzapine Risperidone Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin |
Schizophrenia Quetiapine Dopamine Mental Disorders Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents Ziprasidone Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Serotonin Antagonists Mental Disorders Therapeutic Uses Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Tranquilizing Agents Gastrointestinal Agents |
Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Quetiapine Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Ziprasidone Central Nervous System Agents |