NCT01446328

Bergen Psychosis Project 2 - The Best Intro Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	Amisulpride	Tablets, dose range 50-1200 mg/ day
DRUG	Aripiprazole	Tablets, dose range 5-30 mg/ day
DRUG	Olanzapine	Tablets, dose range 2.5-20 mg/ day

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2011-10-05
• Last updated: 2020-06-19

Locations

4 sites across 2 countries: Austria, Norway