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

April 16, 2024 updated by: Lars Vedel Kessing, Mental Health Services in the Capital Region, Denmark

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

Not yet recruiting

Conditions

Intervention / Treatment

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 18-65 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 (possibility of 12) months follow-up
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
Time Frame: 6 (possibility of 12) months follow-up
Add-on of Quetiapin >100mg/day, antidepressant drug, or inverse drug during the RCT-period
6 (possibility of 12) months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 5, 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)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-509607-32-00
  • 10.46540/2096-00007B (Other Grant/Funding Number: Independent Research Fund Denmark)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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