Status:
RECRUITING
Lithium Versus Lamotrigine in Bipolar Disorder, Type II
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Conditions:
Bipolar II Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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.
Detailed Description
Although BDII is more prevalent and with a higher disease burden, including more and longer depressive episodes and lower functioning, than bipolar disorder, type I (BDI), effects of pharmacological t...
Eligibility Criteria
Inclusion
- Bipolar disorder, type II with diagnosis confirmed by SCAN interview
- Age 18-70 years
- Habile (i.e., able to give informed consent)
Exclusion
- 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.
Key Trial Info
Start Date :
May 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06184581
Start Date
May 8 2024
End Date
December 1 2027
Last Update
December 26 2025
Active Locations (1)
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1
Psychiatric Center Copenhagen
Copenhagen, Denmark