Lithium Versus Lamotrigine in Bipolar Disorder, Type II

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mental Health Services in the Capital Region, Denmark
• Treatments: Lamotrigine; Lithium Carbonate

Criteria

Inclusion Criteria:

• Bipolar disorder, type II with diagnosis confirmed by SCAN interview

• Age 18-65 years

• Habile (i.e., able to give informed consent)

• Speaks Danish

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.