Clinical Trials in Denmark / NCT06184581
Recruiting
Phase 4
Lithium Versus Lamotrigine in Bipolar Disorder, Type II
NCT06184581 · tracked via the Priya Life Science Denmark tracker
Condition(s) studied
Bipolar II Disorder
Investigational drug(s) / intervention(s)
Lithium Carbonate: The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
Lamotrigine: The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Mood stabilization — 6 (possibility of 12) months follow-up
Mood Stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso app. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Psychiatric Center Copenhagen | Copenhagen | Denmark | Recruiting |
On this site
📄 Lamictal (lamotrigine) drug profile →More University Hospital Bispebjerg and Frederiksberg trials in Denmark
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06184581 on ClinicalTrials.gov ↗ ← All trials in Denmark