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Completed

NCT Number: NCT01446328

Bergen Psychosis Project 2 - The Best Intro 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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Universität Innsbruck, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

  • 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.

Treatment and study plan

Amisulpride

Drug

Tablets, dose range 50-1200 mg/ day

Other names: Solian

Aripiprazole

Drug

Tablets, dose range 5-30 mg/ day

Other names: Abilify

Olanzapine

Drug

Tablets, dose range 2.5-20 mg/ day

Other names: Zyprexa

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

  4. Change of the Global Assessment of Functioning scale

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

  7. Change of serum High Density lipoprotein

    Time frame: 12 months

  8. Change of serum Low Density lipoprotein

    Time frame: 12 months

  9. Change of serum total cholesterols

    Time frame: 12 months

  10. Change of serum triglycerides

    Time frame: 12 months

  11. Change of serum fasting glucose

    Time frame: 12 months

  12. Change of prolactin

    Time frame: 12 months

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

    Time frame: 12 months

  14. Change of body mass index

    Time frame: 12 months

    body weight in kilograms divided by the squared height in metres

  15. Change of waist circumference

    Time frame: 12 months

  16. Change of hip circumference

    Time frame: 12 months

  17. Change of systolic blood pressure

    Time frame: 12 months

  18. Change of diastolic blood pressure

    Time frame: 12 months

Other outcomes

  1. Change of cognitive functions

    Time frame: 12 months

  2. Change of mood symptoms

    Time frame: 12 months

  3. Change of brain functional measures

    Time frame: 12 months

    Based on functional MRI - explorative

  4. Change of brain structural measures

    Time frame: 12 months

    Based on structural MRI - explorative

  5. Change of inflammatory markers in blood

    Time frame: 12 months

  6. Change of gene expression in blood

    Time frame: 12 months

  7. Change of bone turnover markers in serum

    Time frame: 12 months

  8. Change of motor activity

    Time frame: 12 months

    Measured by actigraph

  9. Change of autonomic activity

    Time frame: 12 months

    Measured by actiheart

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Vest

Registry information

Official study title

Bergen Psychosis Project 2 - The Bergen-Stavanger-Innsbruck-Trondheim Study

Acronym: BP2

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2011
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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