People experiencing an episode of depression Mental and Behavioural Disorders
Conditions
Interventions
A lithium supplement which is currently available to purchase worldwide over the counter.
Formulation: Lithium orotate
Dose: up to 20 mg per day
Duration: Up to 6 months
Sponsors
Institute of Psychiatry, Psychology & Neuroscience and South London & Maudsley NHS Foundation Trust joint office
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 21/04/2026: 1. Aged between 18 - 65 years at study entry 2. Meet DSM-5 criteria for a current depressive episode (MINI) 3. Undergoing stable pharmacological treatment for depression (intervention/dose unchanged for >6 weeks) 4. Willing to try a commercially available lithium supplement 5. Willing to attend planned study visits _____ Previous key inclusion criteria: 1. Aged between 18 - 65 years at study entry 2. Meet DSM-5 criteria for a current depressive episode (MINI) and exceed thresholds indicating presence of mixed features (Internal States Scale; ISS) 3. Undergoing stable pharmacological treatment for depression (intervention/dose unchanged for >6 weeks) 4. Willing to try a commercially available lithium supplement 5. Willing to attend planned study visits
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of bipolar disorder. 2. Other health condition that is severely impairing 3. Known contraindication to lithium treatment. This includes currently taking lithium 4. Unable to communicate fluently in English 5. Suicide risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 21/04/2026: 1. LiOr bioavailability is measured via lithium levels in serum (as per standard assay) at 2, 8, 16 and 26 weeks from baseline 2. LiOR acceptability is measured via self-report adherence (using the Tablet Routine Questionnaire) at baseline, 2, 8, 16 and 26 weeks – and via discontinuation rates at the same time points 3. LiOr subjective experiences is measured using participant-reported positive (using non-validated questions) and negative experiences (using the LiSERS scale) baseline, 2, 8, 16 and 26 weeks 4. Protocol feasibility - rates of recruitment, attrition and missing data (in putative primary outcome; below) at 2, 8, 16 and 26 weeks from baseline _____ Previous primary outcome(s): 1. LiOr bioavailability is measured via lithium levels in serum (as per standard assay) at 2, 4, 8, 16 and 26 weeks from baseline 2. LiOR acceptability is measured via self-report adherence (using the Tablet Routine Questionnaire) at baseline, 2, 4, 8, 16 and 26 weeks – and via discontinuation rates at the same time points 3. LiOr subjective experiences is measured using participant-reported positive (using non-validated questions) and negative experiences (using the LiSERS scale) baseline, 2, 4, 8, 16 and 26 weeks 4. Protocol feasibility - rates of recruitment, attrition and missing data (in putative primary outcome; below) at 2, 4, 8, 16 and 26 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 21/04/2026: 1. Candidate biomarker changes i.e., c-reactive protein is measured (as per standard assay) at baseline, 2, 8, 16 and 26 weeks. 2. Mood (putative primary outcome measure) changes are measured at baseline, 2, 8, 16 and 26 weeks, using 1) the Maudsley visual analogue scales for depression and mania, 2) the internal states scale (ISS), 3) the generalised anxiety disorder 7-item questionnaire (GAD7), 4) the inventory of depressive symptoms (IDS) and 5) the young mania rating scale (YMRS). 3. Functioning and cognition (putative secondary measures) changes are measured at baseline, 2, 8, 16 and 26 weeks, using 1) the Functional Assessment Short Test (FAST) and 2) Perceived Deficits Questionnaire - Depression (PDQ-D), Digit Span, Digit Symbol Coding Test (DSCT) _____ Previous key secondary outcome(s): 1. Candidate biomarker changes i.e., c-reactive protein is measured (as per standard assay) at baseline, 2, 4, 8, 16 and 26 weeks. 2. Mood (putative primary outcome measure) changes are measured at baseline, 2, 4, 8, 16 and 26 weeks, using 1) the Maudsley visual analogue scales for depression and mania, 2) the internal states scale (ISS), 3) the generalised anxiety disorder 7-item questionnaire (GAD7), 4) the inventory of depressive symptoms (IDS) and 5) the young mania rating scale (YMRS). 3. Functioning and cognition (putative secondary measures) changes are measured at baseline, 2, 4, 8, 16 and 26 weeks, using 1) the Functional Assessment Short Test (FAST) and 2) the THINC-IT cognitive battery. | — |
Countries
England, United Kingdom
Contacts
Public ContactRebecca Strawbridge
Outcome results
None listed