drugset / Trial / NCT00188643

Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression

NCT00188643

Phase 4 Completed 40 enrolled University Health Network, Toronto
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2002-01
Primary completion
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lamotrigine Small molecule
Subject Venlafaxine Small molecule

Indications