Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01164059
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : June 22, 2015
Sponsor:
Collaborator:
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.

Layout table for study information
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT01164059


Locations
Show Show 18 study locations
Sponsors and Collaborators
University of Bremen
German Federal Ministry of Education and Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof. Dr. Eckart Rüther, Principal Investigator, University of Bremen
ClinicalTrials.gov Identifier: NCT01164059    
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:
Schizophrenia
atypical antipsychotic drugs
conventional antipsychotic drugs
olanzapine
quetiapine
aripiprazole
haloperidol
flupentixol
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol
Olanzapine
Quetiapine Fumarate
Aripiprazole
Haloperidol decanoate
Flupenthixol
Flupenthixol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents
Dopamine Agonists
Dopamine Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists