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SchizophreniaPhase 4NeSSyNCT01164059

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

A Phase 4 study testing Olanzapine, Flupentixol and Quetiapine in people with Schizophrenia, run by University of Bremen at 18 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Olanzapine, Flupentixol and Quetiapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
18 sitesGermany
Study dates
Feb 2010to Mar 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Schizophrenia
  • age 18-65 years
  • necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects
  • written informed consent

Who cannot join

  • Known or suspected hypersensitivity to olanzapine, quetiapine, aripiprazole, flupentixol or haloperidol
  • Acute suicidal tendency
  • "Einwilligungsvorbehalt (BGB)" or "Unterbringung (PsychKG)"
  • Epilepsy
  • Organic psychosis
  • Parkinson Disease
Show all 9Show fewer
  • Dementia
  • History of malignant neuroleptic syndrome
  • QTc interval ≥ 0.5s / history of congenital QTc prolongation

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Germany18 sites

  • Universitätsklinikum Aachen

    Aachen

  • Krankenhaus Angermünde

    Angermünde

  • Karl-Jaspers-Klinik

    Bad Zwischenahn

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Vivantes Klinikum Neukölln

    Berlin

  • LWL-Universitätsklinik Bochum der Ruhr-Universität

    Bochum

  • Klinikum Bremen-Ost gGmbH

    Bremen

  • Rheinische Kliniken Düsseldorf der Heinrich-Heine-Universität

    Düsseldorf

  • Städtisches Krankenhaus Eisenhüttenstadt GmbH

    Eisenhüttenstadt

  • Universitätsmedizin Göttingen

    Göttingen

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Privat-Nerven-Klinik Dr. med. Kurt Fontheim

    Liebenburg

  • Dietrich-Bonhoeffer-Klinik Neubrandenburg

    Neubrandenburg

  • Ruppiner Kliniken

    Neuruppin

  • Ernst von Bergmann Klinikum

    Potsdam

  • Immanuel Klinik Rüdersdorf

    Rüdersdorf

  • Klinik Taufkirchen

    Taufkirchen

Other trials in Germany

About this study

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

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.

Read the 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
Being tested
Olanzapine, Flupentixol, Quetiapine, Aripiprazole, Haloperidol
Keywords
Schizophrenia, atypical antipsychotic drugs, conventional antipsychotic drugs, olanzapine, quetiapine, aripiprazole, haloperidol, flupentixol
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlanzapineDrug

    Olanzapine 10, 15, or 20 mg / day

  • FlupentixolDrug

    Flupentixol 6, 9, or 12 mg / day

  • QuetiapineDrug

    Quetiapine 400, 600, or 800 mg / day

  • AripiprazoleDrug

    Aripiprazole 10, 15, or 20 mg / day

  • HaloperidolDrug

    Haloperidol 3, 4.5, or 6 mg / day

Study groups in NCT01164059
Study groupRoleWhat they receive
atypical antipsychoticsExperimentalOlanzapine, Quetiapine, or Aripiprazole
Receives: Drug: Olanzapine; Drug: Quetiapine; Drug: Aripiprazole
typical antipsychoticsActive comparatorHaloperidol or Flupentixol
Receives: Drug: Flupentixol; Drug: Haloperidol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contentment with treatment: Patient (SF-36)

    Measured: 24 weeks

  2. Contentment with treatment: Psychiatrist (CGI)

    Measured: 24 weeks

Secondary outcomes (3)

  1. Subscores of SF-36

    Measured: 24 weeks

  2. Subjective wellbeing under neuroleptic treatment scale (SWN-K)

    Measured: 24 weeks

  3. Positive and Negative Syndrome Scale (PANSS)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionAug 2013
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01164059
Sponsor's protocol ID
NeSSy_200901
Other IDs
2009-010966-47, 2009
Acronym
NeSSy
Status last verified
Jun 2015
First submitted
6 Jul 2010
Last updated
22 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38958149

  • 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.

    PubMed 30981585

  • 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.

    PubMed 27265548

  • 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.

    PubMed 27016729

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olanzapine, Flupentixol and Quetiapine in people with Schizophrenia, run by University of Bremen at 18 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contentment with treatment: Patient (SF-36) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01164059, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.

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