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Bergen Psychosis Project 2 - The Best Intro Study

NCT01446328 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2020-06-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Helse Vest

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Erik Johnsen, M.D., Ph.D. · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Austria
  • Norway

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446328 on ClinicalTrials.gov