Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia (NeSSy)
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| ClinicalTrials.gov Identifier: NCT01164059 |
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Recruitment Status :
Completed
First Posted : July 16, 2010
Last Update Posted : June 22, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Olanzapine Drug: Flupentixol Drug: Quetiapine Drug: Aripiprazole Drug: Haloperidol | Phase 4 |
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
- that different neuroleptic strategies will be compared rather than single antipsychotic drugs, using
- 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;
- that clinically relevant endpoints such as quality of life will be the primary variables, and
- 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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: atypical antipsychotics
Olanzapine, Quetiapine, or Aripiprazole
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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 |
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Active Comparator: typical antipsychotics
Haloperidol or Flupentixol
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Drug: Flupentixol
Flupentixol 6, 9, or 12 mg / day Drug: Haloperidol Haloperidol 3, 4.5, or 6 mg / day |
- Contentment with treatment: Patient (SF-36) [ Time Frame: 24 weeks ]
- Contentment with treatment: Psychiatrist (CGI) [ Time Frame: 24 weeks ]
- Subscores of SF-36 [ Time Frame: 24 weeks ]
- Subjective wellbeing under neuroleptic treatment scale (SWN-K) [ Time Frame: 24 weeks ]
- Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 24 weeks ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| 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 |
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Schizophrenia atypical antipsychotic drugs conventional antipsychotic drugs olanzapine |
quetiapine aripiprazole haloperidol flupentixol |
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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 |