Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia
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
Outcome
Mixed primary results
paper Primary outcomes were change from baseline to week 24 in quality of life (SF-36) and clinical global impression (CGI-I) PMID 27265548 ↗
paper SF-36 were significantly higher in the SGA group than in the FGA group (85·1 [SD 14·7] vs 79·7 [17·3], p=0·0112). PMID 27265548 ↗
paper not significantly different between the two groups (3·39 [SD 0·89] in the FGA group vs 3·26 [0·92] in the SGA group, p=0·3423). PMID 27265548 ↗
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 |