Clinical trial NCT01446328: Bergen Psychosis Project 2 - The Best Intro Study
Official title: Bergen Psychosis Project 2 - The Bergen-Stavanger-Innsbruck-Trondheim Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Psychotic Disorders
Keywords: Antipsychotic Drugs
Randomized Controlled Trial
Treatment Effectiveness
Translational Research
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Vest
First posted: 2011-10-05
Enrollment: 151
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of the Positive and Negative Syndrome Scale total score
timeFrame: 12 months
Secondary outcomes:
measure: Change of the positive subscale scores of the Positive and Negative Syndrome Scale
timeFrame: 12 months
measure: Change of the negative subscale scores of the Positive and Negative Syndrome Scale
timeFrame: 12 months
measure: Change of the general subscale scores of the Positive and Negative Syndrome Scale
timeFrame: 12 months
measure: Change of the Global Assessment of Functioning scale
timeFrame: 12 months
measure: Change of the Clinical Global Impression - Severity of Illness score
timeFrame: 12 months
measure: Change of the UKU Side Effects Rating Scale - Patient version score
timeFrame: 12 months
measure: Change of serum High Density lipoprotein
timeFrame: 12 months
measure: Change of serum Low Density lipoprotein
timeFrame: 12 months
measure: Change of serum total cholesterols
timeFrame: 12 months
measure: Change of serum triglycerides
timeFrame: 12 months
measure: Change of serum fasting glucose
timeFrame: 12 months
measure: Change of prolactin
timeFrame: 12 months
measure: Change of the rate-corrected QT interval at electrocardiogram
timeFrame: 12 months
measure: Change of body mass index
timeFrame: 12 months
measure: Change of waist circumference
timeFrame: 12 months
measure: Change of hip circumference
timeFrame: 12 months
measure: Change of systolic blood pressure
timeFrame: 12 months
measure: Change of diastolic blood pressure
timeFrame: 12 months
Other outcomes:
measure: Change of cognitive functions
timeFrame: 12 months
measure: Change of mood symptoms
timeFrame: 12 months
measure: Change of brain functional measures
timeFrame: 12 months
measure: Change of brain structural measures
timeFrame: 12 months
measure: Change of inflammatory markers in blood
timeFrame: 12 months
measure: Change of gene expression in blood
timeFrame: 12 months
measure: Change of bone turnover markers in serum
timeFrame: 12 months
measure: Change of motor activity
timeFrame: 12 months
measure: Change of autonomic activity
timeFrame: 12 months
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Erik Johnsen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.