Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia

Study Overview
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Brief Summary
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This study is designed to compare the efficacy and drug tolerability of two strategies for the treatment of schizophrenia. The two strategies consist of utilizing, on the one hand, a conventional antipsychotic like haloperidol or flupentixol and, on the other hand, a newer antipsychotic compound like olanzapine, quetiapine or aripiprazole in patients with schizophrenia.

Detailed Description
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There is agreement in the psychiatry community that the so-called atypical antipsychotics should be considered first choice in the treatment of schizophrenic disorders. However, the general superiority of these newer antipsychotic drugs over the older conventional drugs could not be clearly demonstrated in recent controlled clinical trials. The discrepancy between every day's clinical perception and the results of clinical trials raises the question whether the studies performed so far employed the adequate methodological approach to represent the daily practice situation which is characterized by a wide variety of duration and type of the schizophrenic disorder, concomitant diseases, and medications. Moreover, some studies might not have been focused adequately on patient-relevant outcome variables. The present study project is designed to answer these open questions. The innovative character of the study design is that different neuroleptic strategies will be compared rather than single antipsychotic drugs, using an enhanced biometric design, that provides a choice of treatment with respect to the individual patient though the trial as such is randomised controlled and double blind; that clinically relevant endpoints such as quality of life will be the primary variables, and inclusion and exclusion criteria lead to a study population representing clinical every day practice as near as possible. Another innovatory procedure is that serum levels of the study drugs will be recorded twice during the study. The authors hope that their design might yield transfer effects for other clinical trials facing similar problems.

Official Title
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Clinical Effectiveness Of The Newer Antipsychotic Compounds Olanzapine, Quetiapine And Aripiprazole In Comparison With Low Dose Conventional Antipsychotics (Haloperidol And Flupentixol) In Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Flupentixol
* Drug: Quetiapine
* Drug: Aripiprazole
* Drug: Haloperidol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia age 18-65 years necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects written informed consent Exclusion Criteria (amongst others): Known or suspected hypersensitivity to olanzapine, quetiapine, aripiprazole, flupentixol or haloperidol Acute suicidal tendency Einwilligungsvorbehalt (BGB) or Unterbringung (PsychKG) Epilepsy Organic psychosis Parkinson Disease Dementia History of malignant neuroleptic syndrome QTc interval ≥ 0.5s / history of congenital QTc prolongation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atypical antipsychotics<br>Olanzapine, Quetiapine, or Aripiprazole | Drug: Olanzapine<br>* Olanzapine 10, 15, or 20 mg / day<br>Drug: Quetiapine<br>* Quetiapine 400, 600, or 800 mg / day<br>Drug: Aripiprazole<br>* Aripiprazole 10, 15, or 20 mg / day<br>|
| Active Comparator: typical antipsychotics<br>Haloperidol or Flupentixol | Drug: Flupentixol<br>* Flupentixol 6, 9, or 12 mg / day<br>Drug: Haloperidol<br>* Haloperidol 3, 4.5, or 6 mg / day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contentment with treatment: Patient (SF-36) |  | 24 weeks | 
| Contentment with treatment: Psychiatrist (CGI) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subscores of SF-36 |  | 24 weeks | 
| Subjective wellbeing under neuroleptic treatment scale (SWN-K) |  | 24 weeks | 
| Positive and Negative Syndrome Scale (PANSS) |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, atypical antipsychotic drugs, conventional antipsychotic drugs, olanzapine, quetiapine, aripiprazole, haloperidol, flupentixol