drugset / Trial / NCT01446328
Bergen Psychosis Project 2 - The Best Intro Study
RandomizedParallel-groupSingle-blindTreatment
Summary
In the Bergen Psychosis Project 2 the antipsychotic drugs aripiprazole, amisulpride, and olanzapine will be compared head-to-head in patients with schizophrenia and related psychoses and followed for 12 months. The study is independent of the pharmaceutical industry, and in accordance with a pragmatic design a clinically relevant sample will be included with as few exclusion criteria as possible. The patients will be assessed repeatedly with regards to symptoms, side effects, and cognitive functioning, as well as laboratory parameters. The study hypothesis is that clinically meaningful differences among the drugs will be disclosed in a pragmatic design.
Timeline
- Start
- 2011-10
- Primary completion
- 2017-12
- Completion
- 2017-12
Publications
- Torsvik A, Trentani A, Stokowy TK, Skrede S, Joa I, Klaebo Reitan SM, Rettenbacher M, Kroken RA, Johnsen E, Steen VM. Three-week effect of amisulpride, aripiprazole, and olanzapine on gene expression in peripheral blood in individuals with schizophrenia spectrum disorders. Int J Neuropsychopharmacol. 2026 Jun 2;29(6):pyag019. doi: 10.1093/ijnp/pyag019.
- Morkved N, Bryntesen PS, Eggen IM, Johnsen E, Kroken RA, Bartz-Johannessen CA, Huiberts A, Burgess C, Joa I, Rettenbacher M, Loberg EM. The relationship between childhood maltreatment and trauma and psychosis is not moderated by parental mental health. BMC Psychiatry. 2025 Aug 6;25(1):766. doi: 10.1186/s12888-025-07190-8.
- Stabell LA, Johnsen E, Kroken RA, Loberg EM, Blindheim A, Joa I, Reitan SK, Rettenbacher M, Munk-Jorgensen P, Gjestad R. Clinical insight among persons with schizophrenia spectrum disorders treated with amisulpride, aripiprazole or olanzapine: a semi-randomised trial. BMC Psychiatry. 2023 Jun 29;23(1):482. doi: 10.1186/s12888-023-04981-9.
- Fathian F, Gjestad R, Kroken RA, Loberg EM, Reitan SK, Fleichhacker WW, Rettenbacher M, Larsen TK, Joa I, Stabell LA, Kjelby E, Sinkevicute I, Alisauskiene R, Steen VM, Johnsen E. Association between C-reactive protein levels and antipsychotic treatment during 12 months follow-up period after acute psychosis. Schizophr Res. 2022 Mar;241:174-183. doi: 10.1016/j.schres.2022.01.049. Epub 2022 Feb 4.
- Hoekstra S, Bartz-Johannessen C, Sinkeviciute I, Reitan SK, Kroken RA, Loberg EM, Larsen TK, Rettenbacher M, Johnsen E, Sommer IE. Sex differences in antipsychotic efficacy and side effects in schizophrenia spectrum disorder: results from the BeSt InTro study. NPJ Schizophr. 2021 Aug 18;7(1):39. doi: 10.1038/s41537-021-00170-3.
- Johnsen E, Kroken RA, Loberg EM, Rettenbacher M, Joa I, Larsen TK, Reitan SK, Walla B, Alisauskiene R, Anda LG, Bartz-Johannessen C, Berle JO, Bjarke J, Fathian F, Hugdahl K, Kjelby E, Sinkeviciute I, Skrede S, Stabell L, Steen VM, Fleischhacker WW. Amisulpride, aripiprazole, and olanzapine in patients with schizophrenia-spectrum disorders (BeSt InTro): a pragmatic, rater-blind, semi-randomised trial. Lancet Psychiatry. 2020 Nov;7(11):945-954. doi: 10.1016/S2215-0366(20)30341-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amisulpride | Small molecule | — | Oral |
| Comparator | Aripiprazole | Other / unclassified | — | Oral |
| Comparator | Olanzapine | Small molecule | — | Oral |