People with depression or bipolar disorder taking lithium Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomised in a 1:1 ratio to one of the two treatment arms (TAU, or POC). Randomisation is performed by the King’s College Clinical Trials Unit independent web-based system. Rando
Sponsors
Institute of Psychiatry, Psychology & Neuroscience and South London & Maudsley NHS Foundation Trust joint office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above. 2. Able to give informed consent. 3. A clinical diagnosis of an affective disorders. 4. Taking lithium, with monitoring due every 3 months for the upcoming 6 months and be due for monitoring at the time of consent i.e., due to undergo three serum level tests during the study period (i.e. at baseline, month 3 and month 6).
Exclusion criteria
Exclusion criteria: 1. A planned change in lithium treatment during the 26 week study period. 2. Clinically significant manic symptoms (Young Mania Rating Scale [YMRS] score =20).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim is to assess the feasibility of a novel approach to monitoring lithium (POC) prior to a potential future definitive trial. As such, our primary feasibility outcomes are as follows, for people with affective disorders taking lithium randomised to either POC or usual care: 1.Rates of participant recruitment are measured via data extraction from randomisation system. 2.Rates of participant attrition are measured by ongoing recording by research team. 3.Adherence to lithium monitoring guidelines is measured by patient interviews at months 0, 3 and 6. 4.Acceptability of monitoring is assessed via a monitoring acceptability questionnaire (non-validated) at month 0, 3 and 6. 5.Indications of potential contamination bias are measured by reviewing electronic health records at the end of the study (to ascertain monitoring rates between treatment-exposed vs non-exposed services; analysing changes in monitoring rates from first to last recruitment, examining participants’ monitoring history) and within clinician acceptability surveys (as to practice changes during the trial.) | — |
Secondary
| Measure | Time frame |
|---|---|
| We will also explore change in the following measures over time to inform a future definitive study design: 1. Health economics is measured using the client service receipt inventory and EuroQol5d questionnaires at 0, 3 and 6 months 2. Affective symptoms are measured using the young mania rating scale, Montgomery-asberg depression rating scale and maudsley visual analogue scales at 0, 3 and 6 months 3. Physical health symptoms are measured using the lithium side effects rating scale and adverse effects recording (via patient interview) at 0, 3 and 6 months | — |
Countries
England, United Kingdom
Contacts
Public Contact. Study Team
Outcome results
None listed