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SchizophreniaPhase 4BP2NCT01446328

Bergen Psychosis Project 2 - The Best Intro Study

A Phase 4 study testing Amisulpride, Aripiprazole and Olanzapine in people with Schizophrenia and Psychotic Disorders, run by Haukeland University Hospital at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Schizophrenia, Psychotic Disorders
What is being tested?
Amisulpride, Aripiprazole and Olanzapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
4 sitesin 2 countries
Study dates
Oct 2011to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Inability to understand spoken Norwegian.
  • Patients with organic psychosis due to limbic encephalitis detected by antibodies in serum obtains at inclusion (such as NMDAR, VGKC and paraneoplastic antibodies performed at the Neuroimmunology Laboratory, Department of Neurology, Haukeland University Hospital) Pregnant or breast feeding women.
  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Norway3 sites

  • Haukeland University Hospital

    Bergen, 5223

  • Stavanger University Hospital

    Stavanger

  • St. Olavs Hospital

    Trondheim

Other trials in Norway

Austria1 site

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

Other trials in Austria

About this study

Official title: Bergen Psychosis Project 2 - The Bergen-Stavanger-Innsbruck-Trondheim Study

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.

Being tested
Amisulpride, Aripiprazole, Olanzapine
Keywords
Antipsychotic Drugs, Randomized Controlled Trial, Treatment Effectiveness, Translational Research
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmisulprideDrug

    Also called Solian

    Tablets, dose range 50-1200 mg/ day

  • AripiprazoleDrug

    Also called Abilify

    Tablets, dose range 5-30 mg/ day

  • OlanzapineDrug

    Also called Zyprexa

    Tablets, dose range 2.5-20 mg/ day

Study groups in NCT01446328
Study groupRoleWhat they receive
AmisulprideActive comparatorNot described
Receives: Drug: Amisulpride
AripiprazoleActive comparatorNot described
Receives: Drug: Aripiprazole
OlanzapineActive comparatorNot described
Receives: Drug: Olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of the Positive and Negative Syndrome Scale total score

    Measured: 12 months

Secondary outcomes (18)

  1. Change of the positive subscale scores of the Positive and Negative Syndrome Scale

    Measured: 12 months

  2. Change of the negative subscale scores of the Positive and Negative Syndrome Scale

    Measured: 12 months

  3. Change of the general subscale scores of the Positive and Negative Syndrome Scale

    Measured: 12 months

  4. Change of the Global Assessment of Functioning scale

    Measured: 12 months

  5. Change of the Clinical Global Impression - Severity of Illness score

    Measured: 12 months

  6. Change of the UKU Side Effects Rating Scale - Patient version score

    Measured: 12 months

  7. Change of serum High Density lipoprotein

    Measured: 12 months

  8. Change of serum Low Density lipoprotein

    Measured: 12 months

  9. Change of serum total cholesterols

    Measured: 12 months

  10. Change of serum triglycerides

    Measured: 12 months

  11. Change of serum fasting glucose

    Measured: 12 months

  12. Change of prolactin

    Measured: 12 months

  13. Change of the rate-corrected QT interval at electrocardiogram

    Measured: 12 months

  14. Change of body mass index

    body weight in kilograms divided by the squared height in metres

    Measured: 12 months

  15. Change of waist circumference

    Measured: 12 months

  16. Change of hip circumference

    Measured: 12 months

  17. Change of systolic blood pressure

    Measured: 12 months

  18. Change of diastolic blood pressure

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01446328
Sponsor's protocol ID
2010/3387
Other IDs
11/01070, 2010-022307-22
Acronym
BP2
Status last verified
Jun 2020
First submitted
3 Oct 2011
Last updated
19 Jun 2020
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 42033308

  • 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.

    PubMed 40770798

  • 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.

    PubMed 37386462

  • 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.

    PubMed 35131596

  • 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.

    PubMed 34408155

  • 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.

    PubMed 33069317

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amisulpride, Aripiprazole and Olanzapine in people with Schizophrenia and Psychotic Disorders, run by Haukeland University Hospital at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the Positive and Negative Syndrome Scale total score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01446328, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.

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