Optimising individualised prescribing with therapeutic drug Monitoring for Antipsychotics (OptIMA) 2: clinical pilot study of antipsychotic drug level monitoring

Not Applicable

Completed

• Conditions: Schizophrenia, schizoaffective disorder; Mental and Behavioural Disorders; Schizophrenia

• Registration Number: ISRCTN71305621
• Lead Sponsor: Institute of Psychiatry, Kings College London (UK)

Brief Summary

2015 results in https://pubmed.ncbi.nlm.nih.gov/26040903/ (added 07/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-04
• Study Completion: 2011-09-30
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Aged 18 - 65 years, either sex
2. Schizophrenia/schizoaffective disorder (clinician International Classification of Disease [ICD-10] diagnosis)
3. Symptoms of acute psychosis
4. Admitted in past two weeks to participating inpatient acute wards
5. Routine clinician initiation (including switch/new initiation/recommencement) of regularly daily prescribed olanzapine as antipsychotic monotherapy, i.e., only one daily antipsychotic drug
6. Legally detained participants will be permitted if they have capacity to consent to the study

Exclusion Criteria

1. Use of clozapine in past 12 months (i.e. whose illness has been classified as 'treatment resistant') but who are now prescribed olanzapine. This is because they would not be expected to benefit from changes in olanzapine dosage.
2. Use of another simultaneous regularly prescribed daily antipsychotic (other than p.r.n) at study onset

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Total daily prescribed dose, measured at 6 weeks follow-up<br> 2. Drug discontinuation, measured at 6 weeks follow-up<br><br> Outcome measures will be based on a review of case notes and further participant direct contact will not be required.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Measured at 6 weeks follow-up:<br> 1. Documented evidence of clinician checking the test results, changes to medication regimen (including dose titration)<br> 2. Duration of in-patient stay (and also days in psychiatric intensive care)<br> 3. Use of short-acting intramuscular medication (benzodiazepines, etc.)<br> 4. Rehospitalisation<br> 5. Legal detention status<br> 6. Accuracy and equivalence of saliva antipsychotic level testing in comparison to blood sample testing<br>