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

Mental Health Services in the Capital Region, Denmark

Status and phase: Enrolling; Phase 4

Conditions: Bipolar II Disorder

Treatments: Drug: Lithium Carbonate; Drug: Lamotrigine

Study type: Interventional

Funder types: Other

Identifiers

NCT06184581

2023-509607-32-00

10.46540/2096-00007B (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Lithium

Experimental group

Description:

tablet

Treatment:

Drug: Lithium Carbonate

Lamotrigine

Active Comparator group

Description:

tablet

Treatment:

Drug: Lamotrigine