Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia
NeSSy
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
2 other identifiers
interventional
149
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started Feb 2010
Typical duration for phase_4 schizophrenia
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 6, 2010
CompletedFirst Posted
Study publicly available on registry
July 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedJune 22, 2015
June 1, 2015
3.5 years
July 6, 2010
June 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Contentment with treatment: Patient (SF-36)
24 weeks
Contentment with treatment: Psychiatrist (CGI)
24 weeks
Secondary Outcomes (3)
Subscores of SF-36
24 weeks
Subjective wellbeing under neuroleptic treatment scale (SWN-K)
24 weeks
Positive and Negative Syndrome Scale (PANSS)
24 weeks
Study Arms (2)
atypical antipsychotics
EXPERIMENTALOlanzapine, Quetiapine, or Aripiprazole
typical antipsychotics
ACTIVE COMPARATORHaloperidol or Flupentixol
Interventions
Eligibility Criteria
You may qualify if:
- Schizophrenia
- age 18-65 years
- necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
Related Publications (4)
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.
PMID: 38958149DERIVEDVeselinovic 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.
PMID: 30981585DERIVEDGrunder 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.
PMID: 27265548DERIVEDSchulz 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.
PMID: 27016729DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 6, 2010
First Posted
July 16, 2010
Study Start
February 1, 2010
Primary Completion
August 1, 2013
Study Completion
March 1, 2014
Last Updated
June 22, 2015
Record last verified: 2015-06