Bergen Psychosis Project 2 - The Best Intro Study

Schizophrenia Clinical Trial

— BP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446328
• Other study ID #: 2010/3387
• Secondary ID: 11/010702010-022
• Status: Completed
• Phase: Phase 4
• Start date: October 2011
• Est. completion date: December 2017

Study information

• Verified date: June 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• Amisulpride
Tablets, dose range 50-1200 mg/ day
• Aripiprazole
Tablets, dose range 5-30 mg/ day
• Olanzapine
Tablets, dose range 2.5-20 mg/ day

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital	Stavanger
Norway	St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Vest

Countries where clinical trial is conducted

Austria,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of cognitive functions		12 months
Other	Change of mood symptoms		12 months
Other	Change of brain functional measures	Based on functional MRI - explorative	12 months
Other	Change of brain structural measures	Based on structural MRI - explorative	12 months
Other	Change of inflammatory markers in blood		12 months
Other	Change of gene expression in blood		12 months
Other	Change of bone turnover markers in serum		12 months
Other	Change of motor activity	Measured by actigraph	12 months
Other	Change of autonomic activity	Measured by actiheart	12 months
Primary	Change of the Positive and Negative Syndrome Scale total score		12 months
Secondary	Change of the positive subscale scores of the Positive and Negative Syndrome Scale		12 months
Secondary	Change of the negative subscale scores of the Positive and Negative Syndrome Scale		12 months
Secondary	Change of the general subscale scores of the Positive and Negative Syndrome Scale		12 months
Secondary	Change of the Global Assessment of Functioning scale		12 months
Secondary	Change of the Clinical Global Impression - Severity of Illness score		12 months
Secondary	Change of the UKU Side Effects Rating Scale - Patient version score		12 months
Secondary	Change of serum High Density lipoprotein		12 months
Secondary	Change of serum Low Density lipoprotein		12 months
Secondary	Change of serum total cholesterols		12 months
Secondary	Change of serum triglycerides		12 months
Secondary	Change of serum fasting glucose		12 months
Secondary	Change of prolactin		12 months
Secondary	Change of the rate-corrected QT interval at electrocardiogram		12 months
Secondary	Change of body mass index	body weight in kilograms divided by the squared height in metres	12 months
Secondary	Change of waist circumference		12 months
Secondary	Change of hip circumference		12 months
Secondary	Change of systolic blood pressure		12 months
Secondary	Change of diastolic blood pressure		12 months