Lithium versus Lamotrigine in bipolar disorder, type II – a single blinded randomized controlled trial (the LiLa-Bipolar RCT)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509607-32-00

Enrollment

200

Registered

2024-03-25

Start date

2024-04-29

Completion date

Unknown

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Type II

Brief summary

Primary: Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system (see section 2.3.4 in Protocol).

Detailed description

Young mania rating scale, Hamilton Rating Scale for Depression (17 items), functional assessment short test, Internet-based Cognition Assessment Tool (ICAT), blood based inflammation markers collected in blood sample, hair cortisol level (see detailed description in section 4 in protocol).

Interventions

DRUGLamictal 25 mg tablete

DRUGLitiumkarbonat "OBA"

DRUGfilmovertrukne tabletter

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Primary: Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system (see section 2.3.4 in Protocol).	—

Secondary

Measure	Time frame
Young mania rating scale, Hamilton Rating Scale for Depression (17 items), functional assessment short test, Internet-based Cognition Assessment Tool (ICAT), blood based inflammation markers collected in blood sample, hair cortisol level (see detailed description in section 4 in protocol).	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026