RECRUITINGPhase 4INTERVENTIONAL
Lithium Versus Lamotrigine in Bipolar Disorder, Type II
Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Bipolar disorder, type II with diagnosis confirmed by SCAN interview
- Age 18-70 years
- Habile (i.e., able to give willing to sign a consent form)
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Lithium Carbonate
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
DRUG
Lamotrigine
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
Locations (1)
Psychiatric Center Copenhagen
Copenhagen, Denmark