Status:
COMPLETED
Bergen Psychosis Project 2 - The Best Intro Study
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
Helse Vest
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01446328
Start Date
October 1 2011
End Date
December 1 2017
Last Update
June 19 2020
Active Locations (4)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
2
Haukeland University Hospital
Bergen, Norway, 5223
3
Stavanger University Hospital
Stavanger, Norway
4
St. Olavs Hospital
Trondheim, Norway