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NCT Number: NCT06184581

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

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.

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Key information

Conditions

Bipolar II Disorder Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Psychiatric Center Copenhagen

Copenhagen, Denmark

Location status: Recruiting

Location contact

Lars Vedel Kessing, professor, MD, DMSc.

CONTACT

[email protected]

+45 38 64 70 81

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lithium Carbonate

Drug

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

Lamotrigine

Drug

The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Non-response

    Time frame: 6 (possibility of 12) months follow-up

    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

  2. Depression

    Time frame: 6 months

    Clinically rated observer-based difference in depression scores over the six-month trial period on the Hamilton Depression Scale-6 items

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Vedel Kessing, professor, MD, DMSc.

CONTACT

[email protected]

+45 38 64 70 81

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Official study title

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

Acronym: LiLa-Bipolar

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 28, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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