Bipolar II Disorder
Conditions
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.
Detailed description
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.
Interventions
DRUGLithium Carbonate
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
DRUGLamotrigine
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
Sponsors
University Hospital Bispebjerg and Frederiksberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
single-blinded two-armed, parallel randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mood stabilization | 6 (possibility of 12) months follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-response | 6 (possibility of 12) months follow-up | 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 |
| Depression | 6 months | Clinically rated observer-based difference in depression scores over the six-month trial period on the Hamilton Depression Scale-6 items |
Countries
Denmark
Contacts
CONTACTLars Vedel Kessing, professor, MD, DMSc.
Outcome results
None listed