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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2010-022184-35-GB
• Date of registration: 06/09/2011
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: A trial to test the effect of amisulpride (antipsychotic) on schizoprenia like disease with onset after age 60
• Scientific title: A pragmatic randomised double-blind trial of Antipsychotic Treatment of very LAte-onset Schizophrenia-like psychosis: The ATLAS Trial - The ATLAS Trial
• Date of first enrolment: 04/10/2011
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022184-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: ATLAS Trial Manager
• Affiliation: Clinical Trial Service Unit

• Name: ATLAS Trial Manager
• Affiliation: Clinical Trial Service Unit

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

late-onset schizophrenia-like psychosis
MedDRA version: 18.1 Level: LLT Classification code 10037234 Term: Psychosis System Organ Class: 100000004873

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

Product Name: Amisulpride
Pharmaceutical Form: Tablet
INN or Proposed INN: AMISULPRIDE
CAS Number: 71675-85-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Brief Psychiatric Rating Scale, a widely used 24-item instrument for assessing positive, negative and affective symptoms in patients with psychotic disorders. Numbers of patients withdrawn from treatment because of perceived ineffectiveness are the trial’s co-primary outcomes for the second (week 12 to 24) stage.

Main Objective: (1) Is amisulpride superior to placebo in the treatment of very late-onset schizophrenia-like psychosis over 12 weeks as measured by significant differences between amisulpride and placebo treated groups in improvements in score on the brief psychiatric rating scale (BPRS) largely driven by improvements in the hostility, suspiciousness, hallucinations, tension, uncooperativeness and motor hyperactivity sub-scores?
(2) Is prolonged treatment after 12 weeks superior to treatment withdrawal to receive placebo over the next 12 weeks as measured by significant differences in BPRS scores between groups and significantly greater numbers of patients in the group randomised to receive placebo being withdrawn to open treatment with amisulpride by their physicians?

Secondary Objective: In addition to the two principal questions we will also investigate the associated risks of side-effects and serious adverse events, the effects of treatment upon quality of life and the cost-effectiveness of amisulpride treatment.

Timepoint(s) of evaluation of this end point: Changes in BPRS score between Baseline and 12 Weeks and between Week 12 and Week 24

Secondary Outcome(s)

Secondary end point(s): Extrapyrimidal side-effects, compliance, quality of life and cost-effectiveness

Timepoint(s) of evaluation of this end point: 4, 10-12, 16 and 22-24 weeks

Secondary ID(s)

ISRCTN45593573

ATLAS

Source(s) of Monetary Support

NIHR

Secondary Sponsor(s)

South London and Maudsley NHS Foundation Trust

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 20/03/2019
• Date Completed: 14/12/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022184-35/results