Lithium Versus Lamotrigine in Bipolar Disorder, Type II (LiLa-Bipolar)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar II Disorder
• Intervention / Treatment: Drug: Lithium Carbonate; Drug: Lamotrigine

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lars Vedel Kessing, professor, MD, DMSc.; Phone Number: +45 38 64 70 81; Email: lars.vedel.kessing@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Psychiatric Center Copenhagen
    • Contact: Lars Vedel Kessing, professor, MD, DMSc.; Phone Number: +45 38 64 70 81; Email: lars.vedel.kessing@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lithium; tablet	Drug: Lithium Carbonate; The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.; Other Names: lithium citrate
Active Comparator: Lamotrigine; tablet	Drug: Lamotrigine; The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-response	Add-on of Quetiapin >100mg/day or another antipsychotic drug, antidepressant drug, or inverse drug during the RCT-period or change from the allocated drug to lithium or lamotrigine	6 (possibility of 12) months follow-up
Depression	Clinically rated observer-based difference in depression scores over the six-month trial period on the Hamilton Depression Scale-6 items	6 months

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Triazines; Alkalies; Carbon Compounds, Inorganic; Carbonates; Carbonic Acid; Lithium Compounds; Lamotrigine; Lithium Carbonate; lithium citrate
• Other Study ID Numbers: 2023-509607-32-00; 10.46540/2096-00007B (Other Grant/Funding Number: Independent Research Fund Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No