Lithium Versus Lamotrigine in Bipolar Disorder, Type II

NCT06184581 | Recruiting Phase 4 DMC

• 2 other identifiers: 2023-509607-32-0010.46540/2096-00007B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar II Disorder

Outcome Measures

Primary Outcomes (1)

• Mood stabilization

  Mood Stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso app. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings.

  6 (possibility of 12) months follow-up

Secondary Outcomes (2)

• Non-response

  6 (possibility of 12) months follow-up

• Depression

  6 months

Study Arms (2)

Lithium

EXPERIMENTAL

tablet

Drug: Lithium Carbonate

Lamotrigine

ACTIVE COMPARATOR

tablet

Drug: Lamotrigine

Interventions

Lithium Carbonate DRUG

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

Also known as: lithium citrate

Lithium

Lamotrigine DRUG

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

Lamotrigine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Psychiatric Center Copenhagen

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium Carbonate; lithium citrate; Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Lars Vedel Kessing, professor, MD, DMSc.

CONTACT

+45 38 64 70 81; lars.vedel.kessing@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD, DMSc.

Model Details: single-blinded two-armed, parallel randomized trial

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: May 8, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)