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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Quetiapine
* Drug: Risperidone
* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Olanzapine<br> | Drug: Olanzapine<br>* Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion<br>* Other names: Zyprexa;Drug: Quetiapine<br>* Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.<br>* Other names: Seroquel;Drug: Ziprasidone<br>* Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion<br>* Other names: Zeldox, Geodon;|
| Active Comparator: Quetiapine<br> | Drug: Olanzapine<br>* Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion<br>* Other names: Zyprexa;Drug: Risperidone<br>* Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.<br>* Other names: Risperdal;Drug: Ziprasidone<br>* Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion<br>* Other names: Zeldox, Geodon;|
| Active Comparator: Risperidone<br> | Drug: Olanzapine<br>* Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion<br>* Other names: Zeldox, Geodon;|
| Active Comparator: Ziprasidone<br> | Drug: Olanzapine<br>* Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion<br>* Other names: Zeldox, Geodon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of PANSS total score |  | Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge | 
| Time until initial drug discontinuation |  | Up to 24 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antipsychotic drugs, Treatment effectiveness, Randomized controlled trial