Lithium Versus Lamotrigine in Bipolar Disorder, Type II
Recruiting · NCT06184581 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Bispebjerg and Frederiksberg
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Bipolar disorder, type II with diagnosis confirmed by SCAN interview
- Age 18-70 years
- Habile (i.e., able to give informed consent)
Exclusion criteria
- Past non-response or intolerance to lamotrigine or lithium with \> 6 weeks treatment at an adequate dosage
- Currently taking mood stabilizers at enrollment in CADIC
- Severe chronic kidney disease
- Severe cardiac insufficiency
- Brugadas syndrome
- Severe hypothyroidism despite treatment
- Women who are pregnant, breastfeeding or planning pregnancy in near future.
Where it is running
1 location listed.
- Psychiatric Center Copenhagen - Copenhagen, Denmark