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

NCT ID: NCT01164059

Last Updated: 2015-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-03-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

atypical antipsychotics

Olanzapine, Quetiapine, or Aripiprazole

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Olanzapine 10, 15, or 20 mg / day

Quetiapine

Intervention Type: DRUG

Quetiapine 400, 600, or 800 mg / day

Aripiprazole

Intervention Type: DRUG

Aripiprazole 10, 15, or 20 mg / day

typical antipsychotics

Haloperidol or Flupentixol

Group Type: ACTIVE_COMPARATOR

Flupentixol

Intervention Type: DRUG

Flupentixol 6, 9, or 12 mg / day

Haloperidol

Intervention Type: DRUG

Haloperidol 3, 4.5, or 6 mg / day

Interventions

Olanzapine

Olanzapine 10, 15, or 20 mg / day

Intervention Type: DRUG

Flupentixol

Flupentixol 6, 9, or 12 mg / day

Intervention Type: DRUG

Quetiapine

Quetiapine 400, 600, or 800 mg / day

Intervention Type: DRUG

Aripiprazole

Aripiprazole 10, 15, or 20 mg / day

Intervention Type: DRUG

Haloperidol

Haloperidol 3, 4.5, or 6 mg / day

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

University of Bremen

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Eckart Rüther

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Hanover, , 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

Countries

Germany

References

Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.

Reference Type: DERIVED

PMID: 38958149 (View on PubMed)

Veselinovic T, Scharpenberg M, Heinze M, Cordes J, Muhlbauer B, Juckel G, Habel U, Ruther E, Timm J, Grunder G; NeSSy Study Group. Disparate effects of first and second generation antipsychotics on cognition in schizophrenia - Findings from the randomized NeSSy trial. Eur Neuropsychopharmacol. 2019 Jun;29(6):720-739. doi: 10.1016/j.euroneuro.2019.03.014. Epub 2019 Apr 10.

Reference Type: DERIVED

PMID: 30981585 (View on PubMed)

Grunder G, Heinze M, Cordes J, Muhlbauer B, Juckel G, Schulz C, Ruther E, Timm J; NeSSy Study Group. Effects of first-generation antipsychotics versus second-generation antipsychotics on quality of life in schizophrenia: a double-blind, randomised study. Lancet Psychiatry. 2016 Aug;3(8):717-729. doi: 10.1016/S2215-0366(16)00085-7. Epub 2016 Jun 2.

Reference Type: DERIVED

PMID: 27265548 (View on PubMed)

Schulz C, Timm J, Cordes J, Grunder G, Muhlbauer B, Ruther E, Heinze M. Patient-oriented randomisation: A new trial design applied in the Neuroleptic Strategy Study. Clin Trials. 2016 Jun;13(3):251-9. doi: 10.1177/1740774516639910. Epub 2016 Mar 25.

Reference Type: DERIVED

PMID: 27016729 (View on PubMed)

Other Identifiers

2009-010966-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NeSSy_200901

Identifier Type: -

Identifier Source: org_study_id