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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
151
Tablets, dose range 50-1200 mg/ day
Tablets, dose range 5-30 mg/ day
Tablets, dose range 2.5-20 mg/ day
Medizinische Universität Innsbruck
Innsbruck, Austria
Haukeland University Hospital
Bergen, Norway
Stavanger University Hospital
Stavanger, Norway
St. Olavs Hospital
Trondheim, Norway
Change of the Positive and Negative Syndrome Scale total score
Time frame: 12 months
Change of the positive subscale scores of the Positive and Negative Syndrome Scale
Time frame: 12 months
Change of the negative subscale scores of the Positive and Negative Syndrome Scale
Time frame: 12 months
Change of the general subscale scores of the Positive and Negative Syndrome Scale
Time frame: 12 months
Change of the Global Assessment of Functioning scale
Time frame: 12 months
Change of the Clinical Global Impression - Severity of Illness score
Time frame: 12 months
Change of the UKU Side Effects Rating Scale - Patient version score
Time frame: 12 months
Change of serum High Density lipoprotein
Time frame: 12 months
Change of serum Low Density lipoprotein
Time frame: 12 months
Change of serum total cholesterols
Time frame: 12 months
Change of serum triglycerides
Time frame: 12 months
Change of serum fasting glucose
Time frame: 12 months
Change of prolactin
Time frame: 12 months
Change of the rate-corrected QT interval at electrocardiogram
Time frame: 12 months
Change of body mass index
body weight in kilograms divided by the squared height in metres
Time frame: 12 months
Change of waist circumference
Time frame: 12 months
Change of hip circumference
Time frame: 12 months
Change of systolic blood pressure
Time frame: 12 months
Change of diastolic blood pressure
Time frame: 12 months
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