The LiLa-Bipolar RCT
Phase 1
Recruiting
- Conditions
- Bipolar Disorder, Type IITherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2023-509607-32-00
- Lead Sponsor
- Psykiatrisk Center Kobenhavn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
All patients referred to the clinic as newly diagnosed with BDII will routinely be asked for inclusion in the RCT. Patients are included during 1) depressive state, 2) hypomanic state or 3) full or partial remission., Bipolar disorder, type II with diagnoses confirmed by SCAN interview, Age 18-65 years, Speaks and writes Danish at a level equal to mother tongue, 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 mod stabilizers at enrollment in CADIC, Chronic kidney disease with GFR 0-10 ml/min, Severe cardiac insufficiency (NYHA IIIb-IV), Brugadas syndrome, Severe hypothyroidism despite treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method