Condition category
Mental and Behavioural Disorders
Date applied
10/09/2010
Date assigned
04/11/2010
Last edited
08/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maxine Patel

ORCID ID

Contact details

Institute of Psychiatry
King's College London
Box 68
16 De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIHR/CS/009/010

Study information

Scientific title

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

Acronym

OptIMA 2

Study hypothesis

The aim is to refine the method of using plasma level therapeutic drug monitoring (TDM) for olanzapine/risperidone for individual patient antipsychotic dose management in routine acute inpatient settings. This will include confirmation of logistics, methods and refinement of guidance on interpretation of the plasma level results. This includes method for sending samples from various hospital sites to the laboratory, laboratory assay request forms for study participants, clinician understanding and use of algorithm, and speed of rapid feedback of online TDM results to clinicians.

This will be a pilot clinical trial study which is small scale in design for 30 inpatients with acute psychosis prescribed olanzapine or risperidone, with 6-week follow-up data capture. The intervention is assessment of antipsychotic blood levels (plasma concentrations) and this will be conducted for all participants.

This is the second of three studies in the project entitled 'Optimising Individualised prescribing with therapeutic drug Monitoring for Antipsychotics (OptIMA)'.

Ethics approval

South East Research Ethics Committee (REC) pending approval as of 17/09/2010 (ref: 10/H1102/59)

Study design

Small-scale multicentre open pilot clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Schizophrenia, schizoaffective disorder

Intervention

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 sample, 12 hours post-dose, will be collected 7 - 14 days after drug initiation. The sample will be sent with a trial-specific lab analysis request form to the laboratory. The lab results will be available via a secure online system within a target of 3 working days.

The drug concentration method of analysis at this lab will be high performance liquid chromatography with mass spectrometry. The assay is fully validated to FDA GLP standards. Sample requirement is 2 ml plasma (4 ml whole blood required).

Repeat TDM with feedback will be allowed (up to two further times) until a drug plasma level in the olanzapine 20 - 40 ng/mL target range (or risperidone 20 - 60 ng/mL) is reached or up to the point of discharge from the inpatient unit, whichever is earlier.

The newly created clinician guidance algorithm will enable the participant's clinicians to optimise prescribing for individuals based on an objective measure and will facilitate lowest effective dose prescribing. It will also enable clinicians to identify patients with drug levels above the therapeutic window who are at risk of toxicity. It will inform prescribing with plasma levels not as the sole determinant of dosage, but importantly in conjunction with the clinician's and patient’s assessment of symptom change, side effects, and medication adherence.

Participant decision optional extra:
A saliva test for olanzapine or risperidone saliva levels will be offered to the participant. This will be at same time as the primary intervention and will be in addition to the blood test (and not instead of the blood test). The purpose for doing this extra saliva test is to seek evidence of equivalence in accuracy between blood samples and saliva samples for antipsychotic drug level measurements. Although saliva sample testing technology exists, its accuracy and equivalence has not yet been confirmed in comparison to blood sample testing.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/10/2010

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Recruitment of 30 patients

Participant 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

Recruitment start date

01/10/2010

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry, King's College London
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry, Kings College London (UK)

Sponsor details

c/o Ms Jennifer Liebscher
16 De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Clinician Scientist Fellowship Award (ref: NIHR/CS/009/010)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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