Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Phase 4

Recruiting

• Conditions: Bipolar II Disorder
• Interventions: Drug: Lithium Carbonate; Drug: Lamotrigine

• Registration Number: NCT06184581
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

Brief 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.

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-mon...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-28
• Study Start: 2024-05-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lithium	Lithium Carbonate	tablet
Lamotrigine	Lamotrigine	tablet

Primary Outcome Measures

Name	Time	Method
Mood stabilization	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 moo...

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Psychiatric Center Copenhagen; 🇩🇰 Copenhagen, Denmark