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| ID | Type | Description | Link |
|---|---|---|---|
| 11/01070 | Other Identifier | The Norwegian Medicines Agency | |
| 2010-022307-22 | EudraCT Number |
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| Name | Class |
|---|---|
| Helse Vest | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amisulpride | Active Comparator |
| |
| Aripiprazole | Active Comparator |
| |
| Olanzapine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amisulpride | Drug | Tablets, dose range 50-1200 mg/ day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Positive and Negative Syndrome Scale total score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the positive subscale scores of the Positive and Negative Syndrome Scale | 12 months | |
| Change of the negative subscale scores of the Positive and Negative Syndrome Scale | 12 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Change of cognitive functions | 12 months | |
| Change of mood symptoms | 12 months | |
| Change of brain functional measures |
Inclusion Criteria:
A:The observational cohort
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Johnsen, M.D., Ph.D. | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria | |||
| Haukeland University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42033308 | Derived | 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. | |
| 40770798 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| D000068180 | Aripiprazole |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Aripiprazole | Drug | Tablets, dose range 5-30 mg/ day |
|
|
| Olanzapine | Drug | Tablets, dose range 2.5-20 mg/ day |
|
|
| Change of the general subscale scores of the Positive and Negative Syndrome Scale |
| 12 months |
| Change of the Global Assessment of Functioning scale | 12 months |
| Change of the Clinical Global Impression - Severity of Illness score | 12 months |
| Change of the UKU Side Effects Rating Scale - Patient version score | 12 months |
| Change of serum High Density lipoprotein | 12 months |
| Change of serum Low Density lipoprotein | 12 months |
| Change of serum total cholesterols | 12 months |
| Change of serum triglycerides | 12 months |
| Change of serum fasting glucose | 12 months |
| Change of prolactin | 12 months |
| Change of the rate-corrected QT interval at electrocardiogram | 12 months |
| Change of body mass index | body weight in kilograms divided by the squared height in metres | 12 months |
| Change of waist circumference | 12 months |
| Change of hip circumference | 12 months |
| Change of systolic blood pressure | 12 months |
| Change of diastolic blood pressure | 12 months |
Based on functional MRI - explorative |
| 12 months |
| Change of brain structural measures | Based on structural MRI - explorative | 12 months |
| Change of inflammatory markers in blood | 12 months |
| Change of gene expression in blood | 12 months |
| Change of bone turnover markers in serum | 12 months |
| Change of motor activity | Measured by actigraph | 12 months |
| Change of autonomic activity | Measured by actiheart | 12 months |
| Bergen |
| 5223 |
| Norway |
| Stavanger University Hospital | Stavanger | Norway |
| St. Olavs Hospital | Trondheim | Norway |
| 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. |
| 37386462 | Derived | 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. |
| 35131596 | Derived | 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. |
| 34408155 | Derived | 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. |
| 33069317 | Derived | 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. |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |