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Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Recruiting
18-65 years
All
Phase 4

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Overview

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.

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.

Eligibility

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 details
    Bipolar II Disorder

NCT06184581

Mental Health Services in the Capital Region, Denmark

17 June 2024

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