Bergen Psychosis Project 2 - The Best Intro Study

NCT01446328 | Completed Phase 4 DMC

• 3 other identifiers: 2010/338711/010702010-022307-22
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

Antipsychotic Drugs; Randomized Controlled Trial; Treatment Effectiveness; Translational Research

Outcome Measures

Primary Outcomes (1)

• Change of the Positive and Negative Syndrome Scale total score

  12 months

Secondary Outcomes (18)

• 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

• 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

Other Outcomes (9)

• Change of cognitive functions

  12 months

• Change of mood symptoms

  12 months

• Change of brain functional measures

  12 months

Study Arms (3)

Amisulpride

ACTIVE COMPARATOR

Drug: Amisulpride

Aripiprazole

ACTIVE COMPARATOR

Drug: Aripiprazole

Olanzapine

ACTIVE COMPARATOR

Drug: Olanzapine

Interventions

Amisulpride DRUG

Tablets, dose range 50-1200 mg/ day

Also known as: Solian

Amisulpride

Aripiprazole DRUG

Tablets, dose range 5-30 mg/ day

Also known as: Abilify

Aripiprazole

Olanzapine DRUG

Tablets, dose range 2.5-20 mg/ day

Also known as: Zyprexa

Olanzapine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A:The observational cohort
• Patients 16 years old or older
• Active psychosis as determined by a score of 4 or more on one or more of the items Delusions, Hallucinatory behavior, Grandiosity, Suspiciousness/ persecution, or Unusual thought content in the Positive and Negative Syndrome Scale (PANSS).
• Or ICD-10 diagnosis corresponding to psychotic disorders or other mental disorders with psychotic features (F10-F19: .5 (psychotic disorder); F20-F29, F30.2, F31.2, F31.5, F32.3, F33.3). From which eligible patients are recruited to the B:The pragmatic, randomized, controlled trial (The Best Intro Study)
• Patients 18 years and older
• Schizophrenia spectrum and delusional disorder
• Symptoms of psychosis as determined by a score of 4 or more on one or more of the items Delusions, Hallucinatory behavior, Grandiosity, Suspiciousness/ persecution, or Unusual thought content in the Positive and Negative Syndrome Scale (PANSS).

You may not qualify if:

• Inability to understand spoken Norwegian.
• Aripiprazole: Hypersensitivity to the active substance or to any of the excipients
• Amisulpride: Hypersensitivity to the active ingredient or to other ingredients of the medicinal product; concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer; phaeochromocytoma; lactation, combination with the following medications which could induce torsade de pointes: Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide. Class III antiarrhythmic agents such as amiodarone, sotalol. Other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin. Combinations with levodopa.
• Olanzapine: Hypersensitivity to the active substance or to any of the excipients. Patients with known risk of narrow-angle glaucoma.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Vest: collaborator

Study Sites (4)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Haukeland University Hospital

Bergen, 5223, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Related Publications (4)

• 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.

  PMID: 37386462 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.

  PMID: 35131596 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.

  PMID: 34408155 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.

  PMID: 33069317 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Amisulpride; Aripiprazole; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines

Study Officials

• Erik Johnsen, M.D., Ph.D.

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 5, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

NO (3); AU (1)