Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia (NeSSy)

June 19, 2015 updated by: Prof. Dr. Eckart Rüther, University of Bremen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bremen

Collaborators

German Federal Ministry of Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

June 22, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeSSy_200901
  • 2009-010966-47 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Olanzapine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe