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Search / Trial NCT06184581

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Launched by MENTAL HEALTH SERVICES IN THE CAPITAL REGION, DENMARK · Dec 14, 2023

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two medications, lithium and lamotrigine, on people with Bipolar II Disorder. The goal is to see which medication better helps stabilize mood and improve overall health in patients over a six-month period. The trial is currently looking for participants aged 18 to 65 who speak Danish and have a confirmed diagnosis of Bipolar II Disorder.

If you choose to participate, you will be randomly assigned to receive either lithium or lamotrigine. Your progress will be monitored closely throughout the study. However, there are some important criteria for joining, such as not having had serious side effects from these medications in the past or having certain health conditions like severe kidney or heart issues. This study aims to provide valuable information that could help improve treatment options for people with Bipolar II Disorder in the future.

Gender

ALL

Eligibility criteria

  • 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.

About Mental Health Services In The Capital Region, Denmark

The Mental Health Services in the Capital Region of Denmark is a leading clinical trial sponsor dedicated to advancing psychiatric research and improving mental health care delivery. Operating within a robust healthcare framework, the organization focuses on innovative treatment methodologies and evidence-based practices, collaborating with multidisciplinary teams to conduct rigorous clinical trials. By prioritizing patient-centered outcomes and leveraging cutting-edge technology, the Mental Health Services aim to enhance therapeutic interventions and contribute to the global understanding of mental health disorders. Their commitment to research excellence fosters a culture of continuous improvement and collaboration, ultimately striving to elevate the standards of mental health services in the region and beyond.

Locations

Copenhagen, , Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported