At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of Bipolar II Disorder with current depressive episode lasting ≥8 weeks
- ✓HAMD-17 score ≥18 with scores of 3+ on melancholic items (Items 1 or 7)
- ✓Acceptable laboratory screening results (within 2× normal limit, including thyroid function)
- ✕Active suicidality
- ✕History of non-response to antidepressant treatment or any previous treatment with lamotrigine
- ✕History of substance dependence in past year or substance abuse within 4 weeks prior to study entry
- ✕Rapid cycling bipolar disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine: Results From an 8-week, Multicenter, Double-blind, Placebo-controlled Trial
In Brief
A Phase 4 clinical trial evaluating Lamotrigine and Placebos for Depression and 4 related conditions. Completed, enrolled 150 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression. To do this, the investigators will re-analyze a previous clinical trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).
Study Details
Timeline
Interventions
Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.
Placebo tablets