MIDILIA v1
Research type
Research Study
Full title
Monitoring the Inter-Dose Interval for Long-acting Injectable Antipsychotics: pilot for the MIDILIA study
IRAS ID
326343
Contact name
James Richard O'Neill
Contact email
Sponsor organisation
Leeds and York Partnership NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Long-acting injectable antipsychotics (LIAs), also known as ’depots’, are used in psychiatry for patients with psychosis who may struggle for various reasons to take oral medications. LIAs are given periodically, anywhere between weekly and quarterly, and over this time, the amount of drug in the bloodstream fluctuates.\nSome patients experience worsening of symptoms as the level of drug in their system reduces, known as the ’trough’ level. However, there is next to no literature around this topic of variation between doses. The MIDILIA study aims to find out how significant this variation is during a cycle of LIA from ’peak’ to ’trough’. \nAntipsychotics work by binding to and blocking dopamine receptors; a greater proportion of receptors are affected at higher levels in the bloodstream, but this effect plateaus at excessively high levels. Therefore, the rate of change of this binding effect speeds up as plasma level decreases to zero; we hypothesize that patients experience worsening symptoms when this rate is excessively fast.\nResearchers will meet with participants on two separate occasions, firstly a few days after their last LIA injection (‘peak’ level) and again on the day when their next dose is due (‘trough’ level). At each encounter, a questionnaire to assess symptom severity will be completed, along with a blood test to monitor the level of drug in the bloodstream. We will then use existing data from studies using brain scans to estimate the change in proportion of dopamine receptors between ‘peak’ and ‘trough’ levels.\nWe expect that service users would be able to tolerate such change in receptor binding to a degree without significant emergence of symptoms. This trial aims to determine the threshold rate that is typically tolerated; this may then assist in guiding effective reduction and discontinuation regimes to base clinical guidelines around.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0156
Date of REC Opinion
24 May 2023
REC opinion
Further Information Favourable Opinion