Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Last updated: June 6, 2024
Sponsor: Mental Health Services in the Capital Region, Denmark
Overall Status: Active - Recruiting

Phase

4

Condition

Mood Disorders

Bipolar Disorder

Treatment

Lamotrigine

Lithium Carbonate

Clinical Study ID

NCT06184581
2023-509607-32-00
10.46540/2096-00007B
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatmentat 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 Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Lamotrigine
Phase: 4
Study Start date:
May 08, 2024
Estimated Completion Date:
December 01, 2027

Study 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.

Connect with a study center

  • Psychiatric Center Copenhagen

    Copenhagen,
    Denmark

    Active - Recruiting

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