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

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ClinicalTrials.gov Identifier: NCT01446328
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Helse Vest
Information provided by (Responsible Party):
Haukeland University Hospital

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 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 or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorders Drug: Amisulpride Drug: Aripiprazole Drug: Olanzapine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bergen Psychosis Project 2 - The Bergen-Stavanger-Innsbruck-Trondheim Study
Study Start Date : October 2011
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change of the Positive and Negative Syndrome Scale total score [ Time Frame: 12 months ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446328


Locations
Austria
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Norway
Haukeland University Hospital
Bergen, Norway, 5223
Stavanger University Hospital
Stavanger, Norway
St. Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Haukeland University Hospital
Helse Vest
Investigators
Principal Investigator: Erik Johnsen, M.D., Ph.D. Haukeland University Hospital

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01446328     History of Changes
Other Study ID Numbers: 2010/3387
11/01070 ( Other Identifier: The Norwegian Medicines Agency )
2010-022307-22 ( EudraCT Number )
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Aripiprazole
Olanzapine
Sultopride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists
Dopamine Agents