RecruitingPhase 4

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Denmark200 participantsStarted 2024-05-08

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mood stabilization

Timeframe: 6 (possibility of 12) months follow-up

Trial details

NCT IDNCT06184581

SponsorUniversity Hospital Bispebjerg and Frederiksberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Lars Vedel Kessing, professor, MD, DMSc.

+45 38 64 70 81 lars.vedel.kessing@regionh.dk

View on ClinicalTrials.gov More Bipolar II Disorder trials