Bergen Psychosis Project 2 - The Best Intro Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia, Psychotic Disorders

Intervention / Treatment
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* Drug: Amisulpride
* Drug: Aripiprazole
* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amisulpride<br> | Drug: Amisulpride<br>* Tablets, dose range 50-1200 mg/ day<br>* Other names: Solian;|
| Active Comparator: Aripiprazole<br> | Drug: Aripiprazole<br>* Tablets, dose range 5-30 mg/ day<br>* Other names: Abilify;|
| Active Comparator: Olanzapine<br> | Drug: Olanzapine<br>* Tablets, dose range 2.5-20 mg/ day<br>* Other names: Zyprexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Positive and Negative Syndrome Scale total score |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change of the UKU Side Effects Rating Scale - Patient version score |  | 12 months | 
| Change of serum High Density lipoprotein |  | 12 months | 
| Change of serum Low Density lipoprotein |  | 12 months | 
| Change of serum total cholesterols |  | 12 months | 
| Change of serum triglycerides |  | 12 months | 
| Change of serum fasting glucose |  | 12 months | 
| Change of prolactin |  | 12 months | 
| Change of the rate-corrected QT interval at electrocardiogram |  | 12 months | 
| Change of body mass index | body weight in kilograms divided by the squared height in metres | 12 months | 
| Change of waist circumference |  | 12 months | 
| Change of hip circumference |  | 12 months | 
| Change of systolic blood pressure |  | 12 months | 
| Change of diastolic blood pressure |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antipsychotic Drugs, Randomized Controlled Trial, Treatment Effectiveness, Translational Research