CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 151 enrolled
Drug / intervention
Amisulpride +2 moredrug
Likely dose
Amisulpride 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01446328
NCT01446328Phase 4Completed

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

Haukeland University Hospital·interventional·Posted Oct 5, 2011·Updated Jun 19, 2020

In Brief

A Phase 4 clinical trial evaluating Amisulpride, Aripiprazole, and 1 other intervention for Schizophrenia and Psychotic Disorders. Completed, enrolled 151 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Norway
CollaboratorsHelse Vest

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 14.7 years ago

Interventions

Amisulpridedrug

Tablets, dose range 50-1200 mg/ day

Aripiprazoledrug

Tablets, dose range 5-30 mg/ day

Olanzapinedrug

Tablets, dose range 2.5-20 mg/ day