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Optimising Individualised prescribing with therapeutic drug Monitoring for Antipsychotics (OptIMA)3: clinical pilot study of antipsychotic drug level monitoring for dose review

Optimising Individualised prescribing with therapeutic drug Monitoring for Antipsychotics (OptIMA) 3: clinical pilot study of antipsychotic drug level monitoring for dose review - a pilot multicentre open-label single-arm clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN76638113
Enrollment
35
Registered
2014-11-12
Start date
2014-12-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

Psychotic disorders Mental and Behavioural Disorders

Interventions

The intervention is Therapeutic Drug Monitoring with rapid results feedback and a clinician guidance algorithm.

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. People admitted to participating inpatient wards or those under the care of an outpatient clinical service 2. People for whom the treating clinician has identified a need for antipsychotic dose review within routine clinical care 3. Age 18-65 years 4. Current diagnosis from one of the diagnostic categories of ICD-10: F20-F29 5. Regularly prescribed oral olanzapine or risperidone as monotherapy for the treatment of psychotic symptoms 6. Legally detained participants will be included if they have capacity to consent to the study

Exclusion criteria

Exclusion criteria: 1. Current diagnosis of drug induced psychosis (ICD-10 F10-19) 2. Use of clozapine in past 12 months

Design outcomes

Primary

MeasureTime frame
The proportion of participants whose drug plasma level is within target therapeutic range at follow-up (between 4 and 8 weeks after participation in the trial)

Secondary

MeasureTime frame
The proportion of participants whose plasma drug level, at follow-up (between 4 and 8 weeks after participation in the trial), falls within the range above or below the target therapeutic range. The acceptability of these suboptimal plasma level ranges will be assessed with regards to tolerance and clinical response. Tolerance will be measured using the side effect rating scales and response using the Positive and Negative Syndrome Scale at follow-up.

Countries

United Kingdom

Outcome results

None listed

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