RecruitingPhase 4NCT06184581

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

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


Sponsor

University Hospital Bispebjerg and Frederiksberg

Enrollment

200 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • Bipolar disorder, type II with diagnosis confirmed by SCAN interview
  • Age 18-70 years
  • Habile (i.e., able to give informed consent)

Exclusion Criteria7

  • 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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Interventions

DRUGLithium Carbonate

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

DRUGLamotrigine

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


Locations(1)

Psychiatric Center Copenhagen

Copenhagen, Denmark

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NCT06184581


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