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| ID | Type | Description | Link |
|---|---|---|---|
| 10.46540/2096-00007B | Other Grant/Funding Number | Independent Research Fund Denmark |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium | Experimental | tablet |
|
| Lamotrigine | Active Comparator | tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium Carbonate | Drug | The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 (possibility of 12) months follow-up |
| Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Vedel Kessing, professor, MD, DMSc. | Contact | +45 38 64 70 81 | lars.vedel.kessing@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Center Copenhagen | Recruiting | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42103384 | Derived | Fredskild MU, Fussing Bruun CF, Miskowiak KW, Budtz-Jorgensen E, Vinberg M, Faurholt-Jepsen M, Kessing LV. Lithium versus lamotrigine in bipolar disorder type II: protocol for a single-blinded, pragmatic, randomised controlled trial (the LiLa-Bipolar RCT). BMJ Open. 2026 May 8;16(5):e116196. doi: 10.1136/bmjopen-2026-116196. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| C070669 | lithium citrate |
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
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single-blinded two-armed, parallel randomized trial
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|
| Lamotrigine | Drug | The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium. |
|
Clinically rated observer-based difference in depression scores over the six-month trial period on the Hamilton Depression Scale-6 items
| 6 months |
| D017554 |
| Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |