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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Bremen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Prof. Dr. Eckart Rüther, University of Bremen
ClinicalTrials.gov Identifier:
NCT01164059
First received: July 6, 2010
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Olanzapine
Drug: Flupentixol
Drug: Quetiapine
Drug: Aripiprazole
Drug: Haloperidol
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Bremen:

Primary Outcome Measures:
  • Contentment with treatment: Patient (SF-36) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Contentment with treatment: Psychiatrist (CGI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subscores of SF-36 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Subjective wellbeing under neuroleptic treatment scale (SWN-K) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 630
Study Start Date: February 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164059

Contacts
Contact: Eckart Rüther, M.D. +49 89 51605556 eruether@msn.com
Contact: Gerhard Gründer, M.D. +49 241 80 ext 89821 ggruender@ukaachen.de

Locations
Germany
Universitätsklinikum Aachen Recruiting
Aachen, Germany
Contact: Gerhard Gründer, M.D.    +49 241 80 ext 89821    ggruender@ukaachen.de   
Krankenhaus Angermünde Recruiting
Angermünde, Germany
Karl-Jaspers-Klinik Recruiting
Bad Zwischenahn, Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany
Vivantes Klinikum Neukölln Recruiting
Berlin, Germany
LWL-Universitätsklinik Bochum der Ruhr-Universität Recruiting
Bochum, Germany
Klinikum Bremen-Ost gGmbH Active, not recruiting
Bremen, Germany
Rheinische Kliniken Düsseldorf der Heinrich-Heine-Universität Recruiting
Düsseldorf, Germany
Städtisches Krankenhaus Eisenhüttenstadt GmbH Recruiting
Eisenhüttenstadt, Germany
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Privat-Nerven-Klinik Dr. med. Kurt Fontheim Terminated
Liebenburg, Germany
Ruppiner Kliniken Recruiting
Neuruppin, Germany
Ernst von Bergmann Klinikum Recruiting
Potsdam, Germany
Immanuel Klinik Rüdersdorf Recruiting
Rüdersdorf, Germany
Klinik Taufkirchen Recruiting
Taufkirchen, Germany
Sponsors and Collaborators
University of Bremen
German Federal Ministry of Education and Research
  More Information

No publications provided

Responsible Party: Prof. Dr. Eckart Rüther, Principal Investigator, University of Bremen
ClinicalTrials.gov Identifier: NCT01164059     History of Changes
Other Study ID Numbers: NeSSy_200901, 2009-010966-47
Study First Received: July 6, 2010
Last Updated: April 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Bremen:
Schizophrenia
atypical antipsychotic drugs
conventional antipsychotic drugs
olanzapine
quetiapine
aripiprazole
haloperidol
flupentixol

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Flupenthixol
Haloperidol
Haloperidol decanoate
Antipsychotic Agents
Quetiapine
Olanzapine
Aripiprazole
Flupenthixol decanoate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Dyskinesia Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 31, 2014