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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01164059
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : June 22, 2015
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Prof. Dr. Eckart Rüther, 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Olanzapine Drug: Flupentixol Drug: Quetiapine Drug: Aripiprazole Drug: Haloperidol Phase 4

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  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : February 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Contentment with treatment: Patient (SF-36) [ Time Frame: 24 weeks ]
  2. Contentment with treatment: Psychiatrist (CGI) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Subscores of SF-36 [ Time Frame: 24 weeks ]
  2. Subjective wellbeing under neuroleptic treatment scale (SWN-K) [ Time Frame: 24 weeks ]
  3. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01164059

Universitätsklinikum Aachen
Aachen, Germany
Krankenhaus Angermünde
Angermünde, Germany
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, Germany
Sponsors and Collaborators
University of Bremen
German Federal Ministry of Education and Research

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Dr. Eckart Rüther, Principal Investigator, University of Bremen Identifier: NCT01164059     History of Changes
Other Study ID Numbers: NeSSy_200901
2009-010966-47 ( EudraCT Number )
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Keywords provided by Prof. Dr. Eckart Rüther, University of Bremen:
atypical antipsychotic drugs
conventional antipsychotic drugs

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Quetiapine Fumarate
Haloperidol decanoate
Flupenthixol decanoate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents