antipsychotic drug level monitoring for dose review: OptIMA3
Research type
Research Study
Full title
Optimising Individualised prescribing with therapeutic drug Monitoring for Antipsychotics (OptIMA) 3: a clinical pilot study of antipsychotic drug level monitoring for dose review.
IRAS ID
162844
Contact name
Maxine Patel
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN76638113
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Therapeutic drug monitoring (TDM) is the measurement of medication levels in the blood, which vary in response to individual characteristics (e.g. smoking habits). By monitoring drug blood levels, TDM can facilitate medication dose decisions and ensure that levels do not become too high or too low. Guidelines recommend TDM for olanzapine and risperidone, commonly used antipsychotic drugs for schizophrenia, but this is rarely done.
Aim:
To further examine the feasibility of using TDM for olanzapine or risperidone for both inpatients and outpatients at drug initiation or dose review, when the clinician has identified a clinical need (e.g. suspected non-adherence or suboptimal response).Design:
Feasibility study (nonCTIMP) which is small scale and open in design for 35 inpatients and outpatients prescribed olanzapine or risperidone. The intervention is assessment of antipsychotic blood levels and the primary outcome is whether the plasma level at 4-8-week follow-up is within the target range (olanzapine 20-40 ng/mL; risperidone 20-60 ng/mL). Medication management and responsibility will remain with the treating clinician.Rationale:
OptIMA 2 explored the utility and validity of TDM for olanzapine and risperidone. However, as the intervention was offered to any inpatient recently initiated on risperidone or olanzapine, the results were limited by a lack of evident clinical need for TDM. In addition, the primary outcome of dose change was not sufficiently informative of the utility of TDM. Therefore, OptIMA 3 will target the intervention to both inpatients and outpatients whose clinicians have identified a clinical need for TDM at drug initiation or dose review. Additionally, OptIMA 3 will use a more clinically relevant outcome: blood plasma level at follow-up, with consideration of the participant’s tolerance of and response to the antipsychotic. Further, this study will hope to enhance the clinician’s use of the TDM guidance, by user-friendly feedback of results via NHS secure email.REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0028
Date of REC Opinion
15 Jan 2015
REC opinion
Favourable Opinion