The Bergen Pscychosis Project 2

Phase 1

• Conditions: Patients with schizophrenia and related non-affective psychotic disorders, corresponding to ICD-10 diagnoses F10.5-19.5, and F20-29.; MedDRA version: 13.1Level: 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-NO
• Lead Sponsor: Haukeland University Hospital, Division of Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-11
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

a) Patients 18 years and more with symptoms of 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).
b) Fullfilling the diagnostic criteria for one or more of the following ICD-10 diagnoses:
F10.5, F11.5, F12.5, F13.5, F14.5, F15.5, F16.5, F17.5, F18.5, F19.5; F20-29.
c) Antipsychotic drug therapy indicated using the oral formulation of the drugs.
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) Diagnosis of affective psychosis
b) Unable to comply with study protocol
c) Does not understand the language spoken at the investigation site.
d) Patients with organic psychosis due to limbic encephalitis
e) Pregnant or breast feeding women
f)Hypersensitivity to active ingredient or any of the excipients
g) Prolactin-dependent tumours
h) Use of drugs which could induce torsade de pointes
i) Phaeochromocytoma
j) Use of levodopa
k) Known risk of narrow-angle glaucoma

Study & Design

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