Comparing lithium and lamotrigine for treating Bipolar II Disorder
Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
PHASE4 · University Hospital Bispebjerg and Frederiksberg · NCT06184581
This study is testing whether lithium or lamotrigine works better to stabilize mood in people with Bipolar II Disorder.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06184581 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of lithium carbonate and lamotrigine on mood stabilization and other important outcomes in patients diagnosed with Bipolar II Disorder. Conducted over a 6-month period, the study will utilize a randomized controlled trial design to assess the efficacy of these two commonly used medications. The research addresses a significant gap in understanding the pharmacological treatment options for Bipolar II Disorder, which is often overlooked despite its prevalence and impact on patients' lives.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who have a confirmed diagnosis of Bipolar II Disorder and can provide informed consent.
Not a fit: Patients with a history of non-response or intolerance to lamotrigine or lithium, as well as those with severe chronic conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into more effective treatment options for patients with Bipolar II Disorder.
How similar studies have performed: While the specific comparison of lithium and lamotrigine in Bipolar II Disorder is less studied, both medications have been widely used in treating mood disorders, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Copenhagen
- Psychiatric Center Copenhagen — Copenhagen, Denmark (RECRUITING)
Study contacts
- Study coordinator: Lars Vedel Kessing, professor, MD, DMSc.
- Email: lars.vedel.kessing@regionh.dk
- Phone: +45 38 64 70 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar II Disorder