Back to resultsBergen Psychosis Project 2 - The Best Intro Study (BP2)
Primary Purpose
Schizophrenia, Psychotic Disorders
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Amisulpride
Aripiprazole
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Antipsychotic Drugs, Randomized Controlled Trial, Treatment Effectiveness, Translational Research
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.
Sites / Locations
- Medizinische Universität Innsbruck
- Haukeland University Hospital
- Stavanger University Hospital
- St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Amisulpride
Aripiprazole
Olanzapine
Arm Description
Outcomes
Primary Outcome Measures
Change of the Positive and Negative Syndrome Scale total score
Secondary Outcome Measures
Change of the positive subscale scores of the Positive and Negative Syndrome Scale
Change of the negative subscale scores of the Positive and Negative Syndrome Scale
Change of the general subscale scores of the Positive and Negative Syndrome Scale
Change of the Global Assessment of Functioning scale
Change of the Clinical Global Impression - Severity of Illness score
Change of the UKU Side Effects Rating Scale - Patient version score
Change of serum High Density lipoprotein
Change of serum Low Density lipoprotein
Change of serum total cholesterols
Change of serum triglycerides
Change of serum fasting glucose
Change of prolactin
Change of the rate-corrected QT interval at electrocardiogram
Change of body mass index
body weight in kilograms divided by the squared height in metres
Change of waist circumference
Change of hip circumference
Change of systolic blood pressure
Change of diastolic blood pressure
Full Information
NCT ID
NCT01446328
First Posted
October 3, 2011
Last Updated
June 17, 2020
Sponsor
Haukeland University Hospital
Collaborators
Helse Vest
1. Study Identification
Unique Protocol Identification Number
NCT01446328
Brief Title
Bergen Psychosis Project 2 - The Best Intro Study
Acronym
BP2
Official Title
Bergen Psychosis Project 2 - The Bergen-Stavanger-Innsbruck-Trondheim Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Helse Vest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders
Keywords
Antipsychotic Drugs, Randomized Controlled Trial, Treatment Effectiveness, Translational Research
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amisulpride
Arm Type
Active Comparator
Arm Title
Aripiprazole
Arm Type
Active Comparator
Arm Title
Olanzapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amisulpride
Other Intervention Name(s)
Solian
Intervention Description
Tablets, dose range 50-1200 mg/ day
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, dose range 5-30 mg/ day
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
Tablets, dose range 2.5-20 mg/ day
Primary Outcome Measure Information:
Title
Change of the Positive and Negative Syndrome Scale total score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of the positive subscale scores of the Positive and Negative Syndrome Scale
Time Frame
12 months
Title
Change of the negative subscale scores of the Positive and Negative Syndrome Scale
Time Frame
12 months
Title
Change of the general subscale scores of the Positive and Negative Syndrome Scale
Time Frame
12 months
Title
Change of the Global Assessment of Functioning scale
Time Frame
12 months
Title
Change of the Clinical Global Impression - Severity of Illness score
Time Frame
12 months
Title
Change of the UKU Side Effects Rating Scale - Patient version score
Time Frame
12 months
Title
Change of serum High Density lipoprotein
Time Frame
12 months
Title
Change of serum Low Density lipoprotein
Time Frame
12 months
Title
Change of serum total cholesterols
Time Frame
12 months
Title
Change of serum triglycerides
Time Frame
12 months
Title
Change of serum fasting glucose
Time Frame
12 months
Title
Change of prolactin
Time Frame
12 months
Title
Change of the rate-corrected QT interval at electrocardiogram
Time Frame
12 months
Title
Change of body mass index
Description
body weight in kilograms divided by the squared height in metres
Time Frame
12 months
Title
Change of waist circumference
Time Frame
12 months
Title
Change of hip circumference
Time Frame
12 months
Title
Change of systolic blood pressure
Time Frame
12 months
Title
Change of diastolic blood pressure
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Change of cognitive functions
Time Frame
12 months
Title
Change of mood symptoms
Time Frame
12 months
Title
Change of brain functional measures
Description
Based on functional MRI - explorative
Time Frame
12 months
Title
Change of brain structural measures
Description
Based on structural MRI - explorative
Time Frame
12 months
Title
Change of inflammatory markers in blood
Time Frame
12 months
Title
Change of gene expression in blood
Time Frame
12 months
Title
Change of bone turnover markers in serum
Time Frame
12 months
Title
Change of motor activity
Description
Measured by actigraph
Time Frame
12 months
Title
Change of autonomic activity
Description
Measured by actiheart
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Johnsen, M.D., Ph.D.
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5223
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
35131596
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.
Results Reference
derived
PubMed Identifier
34408155
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.
Results Reference
derived
PubMed Identifier
33069317
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.
Results Reference
derived
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Bergen Psychosis Project 2 - The Best Intro Study
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