Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess the efficacy of venlafaxine XR and
lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive
episodes of bipolar I or Bipolar II disorder. Efficacy of therapy will be evaluated using
improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions
on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also
would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to
mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well
as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and
lamotrigine.