drugset / Trial / NCT01164059
Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia
Phase 4
Completed
149 enrolled
University of Bremen
German Federal Ministry of Education and Research · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2010-02
- Primary completion
- 2013-08
- Completion
- 2014-03
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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 10 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 15 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 20 mg | Oral |
| Comparator | Flupentixol | Unknown | 6 mg | Oral |
| Comparator | Flupentixol | Unknown | 9 mg | Oral |
| Comparator | Flupentixol | Unknown | 12 mg | Oral |
| Comparator | Haloperidol | Other / unclassified | 3 mg | Oral |
| Comparator | Haloperidol | Other / unclassified | 4.5 mg | Oral |
| Comparator | Haloperidol | Other / unclassified | 6 mg | Oral |
| Subject | Olanzapine | Small molecule | 10 mg | Oral |
| Subject | Olanzapine | Small molecule | 15 mg | Oral |
| Subject | Olanzapine | Small molecule | 20 mg | Oral |
| Subject | Quetiapine | Small molecule | 400 mg | Oral |
| Subject | Quetiapine | Small molecule | 600 mg | Oral |
| Subject | Quetiapine | Small molecule | 800 mg | Oral |