Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Bipolar II Disorder Clinical Trial

— LiLa-Bipolar  

Official title:

Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184581
• Other study ID #: 2023-509607-32-00
• Secondary ID: 10.46540/2096-00
• Status: Recruiting
• Phase: Phase 4
• Start date: May 8, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: June 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Lars Vedel Kessing, professor, MD, DMSc.
• Phone: +45 38 64 70 81
• Email: lars.vedel.kessing[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Although BDII is more prevalent and with a higher disease burden, including more and longer depressive episodes and lower functioning, than bipolar disorder, type I (BDI), effects of pharmacological treatment including the most frequently used drugs in clinical practice lithium and lamotrigine, is substantially understudied. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Bipolar disorder, type II with diagnosis confirmed by SCAN interview

• Age 18-65 years

• Habile (i.e., able to give informed consent)

• Speaks Danish

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar II Disorder

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Denmark	Psychiatric Center Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mood stabilization	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.	6 (possibility of 12) months follow-up
Secondary	Non-response	Add-on of Quetiapin >100mg/day, antidepressant drug, or inverse drug during the RCT-period	6 (possibility of 12) months follow-up