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Lithium Versus Lamotrigine in Bipolar Disorder, Type II

ConditionBipolar II Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Bipolar disorder, type II with diagnosis confirmed by SCAN interview

Age 18-70 years

Habile (i.e., able to give informed consent)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lithium Carbonate

    Drug

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

  • Lamotrigine

    Drug

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: LithiumExperimental treatment 1 intervention
Group B: LamotrigineActive comparator 1 intervention

Trial outcomes

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.

Time frame
6 (possibility of 12) months follow-up

Secondary outcomes

1

Non-response

Add-on of Quetiapin \>100mg/day or another antipsychotic drug, antidepressant drug, or inverse drug during the RCT-period or change from the allocated drug to lithium or lamotrigine

Time frame
6 (possibility of 12) months follow-up
2

Depression

Clinically rated observer-based difference in depression scores over the six-month trial period on the Hamilton Depression Scale-6 items

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Bispebjerg and Frederiksberg

Lead sponsor

Source ClinicalTrials.gov
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