A proof-of-concept study of an accessible lithium supplement
Overview
Participate in a new study looking at a supplement for people with depression Are you: - Over 18 and having treatment for depression? - Also experiencing ‘high’ symptoms like agitation, racing thoughts, pressure to speak? - Interested in taking part in a research study where you would take a supplement of lithium for up to 6 months? Then you might be eligible to take part in a new research study at King’s College London.
Are you interested in taking part in this study?
Planned end date
31 Aug 2025 00:00Conditions
Depression,ManiaInclusion Criteria
Participants will be:
1) Aged between 18-65 at study entry;
2) Meet DSM-5 criteria for a current depressive episode (MINI interview) and exceed thresholds indicating presence of mixed features (Internal States Scale; ISS);
3) Undergoing stable treatment for depression (intervention/dose unchanged for >6 weeks)
4) Willing to try a commercially available lithium supplement.
Exclusion Criteria
People meeting any of the following criteria will be excluded:
1) Formal diagnosis of bipolar disorder.
2) Other health condition that is severely impairing.
3) Known contraindication to lithium treatment. This includes currently taking lithium. These known contraindications to lithium are used for medication-dose lithium, and there is no evidence to date that these contraindicate microdoses of these supplements, however we are including them to fully ensure no ill effects to our study participants. They are defined as:
• Taking lithium
• Known cardiac disease or cardiac insufficiency
• Known renal impairment
• Known untreated hypothyroidism
• Breast-feeding or pregnancy
• Known hyponatraemia or frequent dehydration
• Addison's disease
• Psoriasis
• Unwilling or unable to abstain from taking any of the following during the study: Non-steroidal anti-inflammatory drugs (NSAID), cyclo-oxygenase-2inhibitors, Angiotensin-Converting Enzyme Inhibitors (ACEI), Angiotensin receptor blockers (ARBs) or diuretics.
• Brugada syndrome or family history of Brugada syndrome.
4) Unable to communicate fluently (defined as ability to read and understand the participant information sheet plus ability to communicate with the researcher throughout screening assessment);
5) Suicide risk (assessed using the MINI interview)
6) Unable to travel to one of the research sites on a regular basis over 6 months;
7) Unable to provide informed consent to participate, for any other reason.
8) Participation in another research study which could potentially influence engagement or outcomes in the present study e.g., presents contraindications with LiOR, examination of another pharmacological or psychological intervention for affective symptoms.