Clinical trial NCT01164059: Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
atypical antipsychotic drugs
conventional antipsychotic drugs
olanzapine
quetiapine
aripiprazole
haloperidol
flupentixol
Lead sponsor: University of Bremen
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2010-07-16
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 (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

Primary outcomes:
measure: Contentment with treatment: Patient (SF-36)
timeFrame: 24 weeks
measure: Contentment with treatment: Psychiatrist (CGI)
timeFrame: 24 weeks
Secondary outcomes:
measure: Subscores of SF-36
timeFrame: 24 weeks
measure: Subjective wellbeing under neuroleptic treatment scale (SWN-K)
timeFrame: 24 weeks
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Angermünde
country: Germany
facility: Krankenhaus Angermünde
city: Bad Zwischenahn
country: Germany
facility: Karl-Jaspers-Klinik
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Bochum
country: Germany
facility: LWL-Universitätsklinik Bochum der Ruhr-Universität
city: Bremen
country: Germany
facility: Klinikum Bremen-Ost gGmbH
city: Düsseldorf
country: Germany
facility: Rheinische Kliniken Düsseldorf der Heinrich-Heine-Universität
city: Eisenhüttenstadt
country: Germany
facility: Städtisches Krankenhaus Eisenhüttenstadt GmbH
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Liebenburg
country: Germany
facility: Privat-Nerven-Klinik Dr. med. Kurt Fontheim
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinik Neubrandenburg
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken
city: Potsdam
country: Germany
facility: Ernst von Bergmann Klinikum
city: Rüdersdorf
country: Germany
facility: Immanuel Klinik Rüdersdorf
city: Taufkirchen
country: Germany
facility: Klinik Taufkirchen
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.