Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Antipsychotics are the main medication of choice for treating mental illnesses such as psychosis and schizophrenia. How these medications are prescribed has remained relatively unchanged for over 50 years. Decisions regarding how much patients should take (the dose) are made without tests or objective clinical measures. Quite often, patients are prescribed the maximum licenced dose of their medication, and in some cases, even more. Monitoring the amount of medicine in the blood may help in decision-making regarding the amount of the drug that should be given, by helping to ensure that there is the right amount of medication, not too much or too little, for the individual person. This is because there is much variation in how different people’s bodies react to different doses. For example, smoking can affect how the human body reacts to drugs. Here, we want to investigate the use of drug levels in the blood for antipsychotics, otherwise known as therapeutic drug monitoring (TDM). This will help us to improve the techniques currently available and to work out which methods are acceptable to both patients and clinicians (such as doctors). We will also be working to try to ensure that the results are presented to clinicians in a way that is easy for them to access and understand.

Who can participate?
Patients aged 18-65 years from inpatient wards or outpatient clinical services, who are regularly prescribed olanzapine or risperidone (two types of antipsychotic drugs).

What does the study involve?
Participants have a clinical interview with a member of the research team. This includes questions about their current mental and physical health and their prescribed medication. A blood sample is taken up to a few days after the interview. The amount of antipsychotic drug in their blood is measured and the test w made available to their doctor/. The doctor may then decide whether or not the dose should be adjusted (increased or reduced). If the dose is adjusted, further blood tests may be suggested in order to check that the adjusted dose has in fact changed the level of the drug in the participant’s blood. Between four and eight weeks later, there will be another clinical interview and final blood sample taken.

What are the possible benefits and risks of participating?
As regards to benefits, there is a potential that the blood test results may help psychiatrists to better understand how an individual’s body is coping with the antipsychotic medication. This may then be used, in addition to other factors such as the severity of the illness, to allow for prescribing drugs tailored to each individual patient. The potential risks and/or disadvantages of participating include answering questions in the clinical interviews that may be sensitive or upsetting, some possible short-lasting discomfort and bruising from the blood test, and a possible delay in taking morning medication until after the research blood sample has been taken.

Where is the study run from?
The study was set up at the Institute of Psychiatry, King’s College London and is being run in the following NHS trusts: South London and Maudsley NHS foundation trust; Central and North West London NHS foundation trust; West London Mental Health NHS trust; South West London and St George’s Mental Health NHS trust; North Essex Partnership NHS foundation trust; and Barnet, Enfield and Haringey NHS trust.

When is the study starting and how long is it expected to run for?
December 2014 to May 2015

Who is funding the study?
National Institute for Health Research (NIHR) (UK) - Clinician Scientist Fellowship Award

Who is the main contact?
Dr Maxine Patel

Trial website

Contact information



Primary contact

Dr Maxine Patel


Contact details

Institute of Psychiatry
Box 68
16 De Crespigny Park
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


OptIMA 3

Study hypothesis

It is hypothesised that the level of risperidone/olanzapine in participant's blood (plasma drug levels)will be within the therapeutic range 4-8 weeks after a first blood sample has been taken for therapeutic drug monitoring.

Ethics approval

Not provided at time of registration

Study design

Small-scale multicentre open pilot clinical trial (nonCTIMP).

Primary study design


Secondary study design


Trial setting


Trial type


Patient information sheet

Not available in web format


Psychotic disorders


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

Intervention type



Phase I

Drug names

Risperidone, olanzapine

Primary outcome measures

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 outcome measures

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.

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant exclusion criteria

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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry,
United Kingdom

Sponsor information


Institute of Psychiatry, King's College London (UK)

Sponsor details

c/o Ms Barbara Dahill
Room 1.8 Hodgkin Building
Guy's Campus
King's College London
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Clinician Scientist Fellowship Award

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes