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

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Olanzapine; Drug: Flupentixol; Drug: Haloperidol; Drug: Quetiapine; Drug: Aripiprazole

• Registration Number: NCT01164059
• Lead Sponsor: University of Bremen

Brief Summary

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

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

1. that different neuroleptic strategies will be compared rather than single antipsychotic drugs, using

2. 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;

3. that clinically relevant endpoints such as quality of life will be the primary variables, and

4. 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2013-08
• Study Completion: 2014-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atypical antipsychotics	Olanzapine	Olanzapine, Quetiapine, or Aripiprazole
typical antipsychotics	Flupentixol	Haloperidol or Flupentixol
typical antipsychotics	Haloperidol	Haloperidol or Flupentixol
atypical antipsychotics	Quetiapine	Olanzapine, Quetiapine, or Aripiprazole
atypical antipsychotics	Aripiprazole	Olanzapine, Quetiapine, or Aripiprazole

Primary Outcome Measures

Name	Time	Method
Contentment with treatment: Psychiatrist (CGI)	24 weeks
Contentment with treatment: Patient (SF-36)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Subscores of SF-36	24 weeks
Subjective wellbeing under neuroleptic treatment scale (SWN-K)	24 weeks
Positive and Negative Syndrome Scale (PANSS)	24 weeks

Trial Locations

Locations (18)

Klinikum Bremen-Ost gGmbH; 🇩🇪 Bremen, Germany

Rheinische Kliniken Düsseldorf der Heinrich-Heine-Universität; 🇩🇪 Düsseldorf, Germany

Privat-Nerven-Klinik Dr. med. Kurt Fontheim; 🇩🇪 Liebenburg, Germany

Ruppiner Kliniken; 🇩🇪 Neuruppin, Germany

Krankenhaus Angermünde; 🇩🇪 Angermünde, Germany

Karl-Jaspers-Klinik; 🇩🇪 Bad Zwischenahn, Germany

Städtisches Krankenhaus Eisenhüttenstadt GmbH; 🇩🇪 Eisenhüttenstadt, Germany

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Immanuel Klinik Rüdersdorf; 🇩🇪 Rüdersdorf, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Vivantes Klinikum Neukölln; 🇩🇪 Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Ernst von Bergmann Klinikum; 🇩🇪 Potsdam, Germany

Klinik Taufkirchen; 🇩🇪 Taufkirchen, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

LWL-Universitätsklinik Bochum der Ruhr-Universität; 🇩🇪 Bochum, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Dietrich-Bonhoeffer-Klinik Neubrandenburg; 🇩🇪 Neubrandenburg, Germany