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

Optimising Individualised prescribing with therapeutic drug Monitoring for Antipsychotics (OptIMA) 2: Clinical pilot study of antipsychotic drug level monitoring - a pilot multicentre open-label single-arm clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71305621

Enrollment

Registered

2010-11-04

Start date

2010-10-01

Completion date

Unknown

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, schizoaffective disorder Mental and Behavioural Disorders Schizophrenia

Interventions

Medication decisions will be made by the participant s own clinician. The intervention is TDM with rapid results feedback and a clinician guidance algorithm. A plasma level blood samp

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026