Bergen Psychosis Project 2 - The Best Intro Study (BP2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Haukeland University Hospital
Sponsor:
Collaborator:
Helse Vest
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01446328
First received: October 3, 2011
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Psychotic Disorders
Drug: Amisulpride
Drug: Aripiprazole
Drug: Olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bergen Psychosis Project 2 - The Bergen-Stavanger-Innsbruck-Trondheim Study

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Change of the Positive and Negative Syndrome Scale total score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amisulpride Drug: Amisulpride
Tablets, dose range 50-1200 mg/ day
Other Name: Solian
Active Comparator: Aripiprazole Drug: Aripiprazole
Tablets, dose range 5-30 mg/ day
Other Name: Abilify
Active Comparator: Olanzapine Drug: Olanzapine
Tablets, dose range 2.5-20 mg/ day
Other Name: Zyprexa

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446328

Contacts
Contact: Erik Johnsen, M.D., Ph.D. +47 ext 55958400 erik.johnsen@helse-bergen.no
Contact: Rune A Kroken, M.D. +47 ext 55958400 rune.kroken@helse-bergen.no

Locations
Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Maria Anna Rettenbacher, MD, PhD    0043512504-23636    Maria.Rettenbacher@i-med.ac.at   
Principal Investigator: Maria Anna Rettenbacher, MD, PhD         
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5223
Contact: Hans Olav Instefjord, Director    +47 ext 55975000    hans.olav.instefjord@helse-bergen.no   
Principal Investigator: Erik Johnsen, M.D., Ph.D.         
Stavanger University Hospital Recruiting
Stavanger, Norway
Contact: Inge Joa, PhD       Ijo@sus.no   
Contact: Tor Ketil Larsen, MD, PhD    +4751515151    tkmaclarsen@mac.com   
Principal Investigator: Tor Ketil Larsen, MD, PhD         
Sponsors and Collaborators
Haukeland University Hospital
Helse Vest
Investigators
Principal Investigator: Erik Johnsen, M.D., Ph.D. Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01446328     History of Changes
Other Study ID Numbers: 2010/3387, 11/01070, 2010-022307-22
Study First Received: October 3, 2011
Last Updated: July 3, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Haukeland University Hospital:
Antipsychotic Drugs
Randomized Controlled Trial
Treatment Effectiveness
Translational Research

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Sultopride
Olanzapine
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 29, 2014