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

Schizophrenia Clinical Trial

— NeSSy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164059
• Other study ID #: NeSSy_200901
• Secondary ID: 2009-010966-47
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2010
• Last updated: June 19, 2015
• Start date: February 2010
• Est. completion date: March 2014

Study information

• Verified date: June 2015
• Source: University of Bremen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Olanzapine
Olanzapine 10, 15, or 20 mg / day
• Flupentixol
Flupentixol 6, 9, or 12 mg / day
• Quetiapine
Quetiapine 400, 600, or 800 mg / day
• Aripiprazole
Aripiprazole 10, 15, or 20 mg / day
• Haloperidol
Haloperidol 3, 4.5, or 6 mg / day

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen
Germany	Krankenhaus Angermünde	Angermünde
Germany	Karl-Jaspers-Klinik	Bad Zwischenahn
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	LWL-Universitätsklinik Bochum der Ruhr-Universität	Bochum
Germany	Klinikum Bremen-Ost gGmbH	Bremen
Germany	Rheinische Kliniken Düsseldorf der Heinrich-Heine-Universität	Düsseldorf
Germany	Städtisches Krankenhaus Eisenhüttenstadt GmbH	Eisenhüttenstadt
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Privat-Nerven-Klinik Dr. med. Kurt Fontheim	Liebenburg
Germany	Dietrich-Bonhoeffer-Klinik Neubrandenburg	Neubrandenburg
Germany	Ruppiner Kliniken	Neuruppin
Germany	Ernst von Bergmann Klinikum	Potsdam
Germany	Immanuel Klinik Rüdersdorf	Rüdersdorf
Germany	Klinik Taufkirchen	Taufkirchen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bremen	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contentment with treatment: Patient (SF-36)		24 weeks	No
Primary	Contentment with treatment: Psychiatrist (CGI)		24 weeks	No
Secondary	Subscores of SF-36		24 weeks	No
Secondary	Subjective wellbeing under neuroleptic treatment scale (SWN-K)		24 weeks	No
Secondary	Positive and Negative Syndrome Scale (PANSS)		24 weeks	No