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Lithium Versus Lamotrigine in Bipolar Disorder, Type II

NCT ID: NCT06184581

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bipolar II Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single-blinded two-armed, parallel randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lithium

tablet

Group Type EXPERIMENTAL

Lithium Carbonate

Intervention Type DRUG

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

Lamotrigine

tablet

Group Type ACTIVE_COMPARATOR

Lamotrigine

Intervention Type DRUG

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

Interventions

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Lithium Carbonate

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

Intervention Type DRUG

Lamotrigine

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

Intervention Type DRUG

Other Intervention Names

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lithium citrate

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Lars Vedel Kessing

professor, MD, DMSc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Psychiatric Center Copenhagen

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lars Vedel Kessing, professor, MD, DMSc.

Role: CONTACT

Phone: +45 38 64 70 81

Email: [email protected]

Facility Contacts

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Lars Vedel Kessing, professor, MD, DMSc.

Role: primary

Other Identifiers

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10.46540/2096-00007B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-509607-32-00

Identifier Type: -

Identifier Source: org_study_id