The Bergen-Stavanger-Innsbruck-Trondheim Study

Phase 1

Active, not recruiting

• Conditions: Patients with schizophrenia and related non-affective psychotic disorders, corresponding to ICD-10 diagnoses F10.5-19.5, and F20-29.; MedDRA version: 19.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-022307-22-AT
• Lead Sponsor: Haukeland University Hospital, Division of Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-27
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

a) Patients 18 years and older
b) Psychotic symptoms compatible with the suffering from schizophrenia (F20, F21, F23.1, F23.2, F25), or paranoid psychosis (F22, F23.3).
(Psychosis will be defined by a score of 4 on one or more of the items: delusions, hallucinatory behavior, grandiosity, suspiciousness/ persecution, unusual thought content in the Positive and Negative Syndrome Scale (PANSS).
(This means that patients with symptoms matching the palette of schizophrenia or paranoid psychosis can also be included for a reliable diagnosis of schizophrenia-range / delusion suffering before a sufficient observation time has been fulfilled without drugs consumption.)
c) Patients, where antipsychotic drug treatment is indicated using the oral formulation of the drugs.
Patient does not take any antipsychotic drugs or shows the indication that the used antipsychotic should be replaced because the current antipsychotics were used long enough and in sufficient quantities without adequate effect, so that change is indexed to another antipsychotic, or the patient has serious side effects, why change is necessary, or the patient has decided to end the current antipsy-chotic treatment.
d) There is no indication to start a clozapine treatment.
e) Written and dated informed consent. (Austria only)
f) Female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without interruption, during the whole duration of participation (This applies unless the subject agrees to absolute and continuous abstinence) and agree to perform a pregnancy test at each study visit and 2 monthly pregnancy tests in the hospital between visit 5 and 6, 6 and 7 and 7 and 8.3
g) The patient is able to understand German. (Austria only)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

a) Patients with organic psychosis (due to limbic encephalitis, Norway only) detected by antibodies in serum obtained at inclusion
b) Pregnant or breast feeding women
c) Concomitant antipsychotic drug treatment
d) Aripiprazole: Hypersensitivity to the active substance or to any of the excipients
e) Amisulpride: Hypersensitivity to the active ingredient or to other ingredi-ents of the medicinal product; Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer; phaechromocy-toma; 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 amiodar-one, sotalol.
Other medications such as bepridil, cisapride, sul-topride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparflox-acin.
Combinations with levodopa.
e) Olanzapine: Hypersensitivity to the active substance or to any of the excipients; Patients with known risk of narrow-angle glaucoma; 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 amiodar-one, sotalol.
Other medications such as bepridil, cisapride, sul-topride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparflox-acin.
Combinations with levodopa.
f) The patient is active in another clinical trial.
g) Inability to understand spoken Norwegian (Norway only)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified