late-onset schizophrenia-like psychosis MedDRA version: 18.1 Level: LLT Classification code 10037234 Term: Psychosis System Organ Class: 100000004873
Conditions
Interventions
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-
P
Sponsors
King's College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Contacts
Public ContactATLAS Trial Manager
Clinical Trial Service Unit
Outcome results
None listed