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: Not yet recruiting

Administrative data

• NCT number: NCT06184581
• Other study ID #: 2023-509607-32-00
• Secondary ID: 10.46540/2096-00
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 5, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: April 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• 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: Not yet 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, 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