A trial to test the effect of amisulpride (antipsychotic) on schizoprenia like disease with onset after age 60

Phase 1

• Conditions: late-onset schizophrenia-like psychosis; MedDRA version: 18.1Level: LLTClassification code 10037234Term: PsychosisSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-022184-35-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-06
• Study Completion: 2016-12-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

(i) Diagnosis of very late-onset schizophrenia-like psychosis as defined by International Consensus Group criteria, including onset of delusions and/or hallucinations after the age of 60 years,
(ii) BPRS score =30, or active psychotic symptoms of a nature and severity that would be consistent with a BPRS score of 30 or greater
(iii) Capacity to give informed consent to inclusion in trial (in the view of the responsible physician).
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

(i) Evidence of significant cognitive impairment and standardised MMSE score <25,
(ii) Uncontrolled serious concomitant physical illness,
(iii) Primary diagnosis of affective disorder,
(iv) Prescribed amisulpride in previous 28 days. (Patients who have been treated with other antipsychotic agents in the previous 28 days but still satisfy the eligibility criteria, and stopping current antipsychotic is considered appropriate, can participate and this will be included as a stratification factor at randomisation);
(v) Contraindication to amisulpride (e.g. phaeochromocytoma, prolactin dependent tumour or potential drug interactions: e.g. with levodopa - see most recent Summary of Product Characteristics http://emc.medicines.org.uk/);
(vi) Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days; or
(vii) Conditions which would prevent participants from having a blood test (eg needle phobia), or may lead to distress during attempts to take blood (eg history of poor intravenous access) will exclude participants from taking part in the optional blood test, but will NOT affect their participation in the trial

Study & Design

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