Bipolar disorder Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomised in a 1:1:1 ratio to a combination of lithium and quetiapine or lithium or quetiapine.
Lithium (carbonate / citrate): initiation in line with usual practice or local Tr
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of BD type I or II according to the DSM-5 confirmed by the Mini-International Neuropsychiatric Interview (MINI). 2. Aged =18 years. 3. Not currently in a mood episode (major depression, mixed episode, hypomania or mania) according to the DSM-5, defined as a score on the Longitudinal Interval Follow-up Evaluation (LIFE) of 4 or below. 4. If already on lithium or quetiapine, the patient and clinician are willing to consider the trial and potentially switch treatment. 5. Able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Primary diagnosis of substance dependence or organic mood disorder. 2. Acute risk to self (clinician opinion). 3. Unstable medical illness that requires acute care (e.g. hospitalisation). 4. Contraindication to lithium or quetiapine: 4.1. Evidence of renal impairment (participant must have an eGFR =60 mls/min/1.73m² within two months prior to consent). 4.2. Medical conditions in which lithium use presents a risk (untreated hypothyroidism, Addison’s disease, untreated epilepsy, cardiac insufficiency, rhythm disorders including Brugada syndrome or family history thereof, psoriasis) 4.3. Incompatible concurrent treatment (such as long term NSAID, diuretic, ACE-I or ARB) for a known medical condition for which no alternative treatment is available 5. Females of child-bearing potential only: 5.1. Pregnant. Note: Spot urine test will be performed before randomisation to rule out pregnancy in females of child-bearing potential 5.2. Not willing to take highly effective contraceptive measures during the study intervention period AND for 30 days following the last trial medication dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first new mood episode over 24 months post-randomisation measured using the Longitudinal Interval Follow-up Evaluation (LIFE) 3 monthly | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first new specified mood episode (mania, hypomania, mixed mood, depressive) over 24 months measured using the LIFE 3 monthly. 2. Number of weeks with mood episodes over 24 months measured using the LIFE 3 monthly. 3. Mania measured using the Young Mania Rating scare (YMRS) 3 monthly. 4. Depression measured using the Montgomery-Asberg Depression Rating Scale (MADRS) 3 monthly. 5. Anxiety measured using the General Anxiety Disorder-7 (GAD-7) at 6, 12, 18 and 24 months. 6. Patient acceptability measured using a visual analogue scale at 12 and 24 months. 7. Tolerability as measured using the UKU scale and Lithium Side Effect Rating Scale (LiSERS) at 12 and 24 months. 8. Time to stopping allocated treatment measured 3 monthly. 9. Treatment adherence measured using the Medication Adherence Rating Scale (MARS) 3 monthly and blood levels. 10. Suicidal ideation measured using the MADRS item 10 and Electronic Health Records (EHR) at 12 and 24 months. 11. Health-related quality of life as measured using the EQ-5D-5L at 6, 12, 18 and 24 months and the Quality of Life in Bipolar Disorder scale (QoL.BD) at 12 and 24 months. 12. Occupational and daily functioning measured using the Functioning Assessment Short Test (FAST) at 12 and 24 months. 13. Occupational/educational outcomes measured at 12 and 24 months. 14. Concomitant medication measured using Electronic Health Records (EHR) at 12 and 24 months. 15. Service utilisation measured using the Client Service Receipt Inventory (CSRI) at 6, 12, 18 and 24 months. 16. Hospitalisation, use of acute services, use of emergency medication, and comorbid mental health conditions measured using the EHR at 12 and 24 months. 17. Physical health (waist circumference, body mass index, blood pressure, random glucose and HbA1c) measured at 12 and 24 months. | — |
Countries
England, United Kingdom
Contacts
Public ContactSamantha Hopkins
Outcome results
None listed