drugset / Trial / NCT00284791

Lamotrigine in Treatment Resistant Depression in Adolescents

NCT00284791

Terminated 50 enrolled MaineHealth GlaxoSmithKline · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary hypothesis of this study is that in fluoxetine (Prozac)-resistant adolescents with Major Depressive Disorder (MDD), Lamotrigine plus fluoxetine will be safe and as effective as sertraline (Zoloft). Our Primary Aim is to determine the efficacy and safety of Lamotrigine-augmentation of fluoxetine for treatment-resistant depression in adolescents. Our Secondary Aims are to characterize the factors associated with treatment-resistance for adolescents with major depression. Also to assess the relationships in the families of adolescents with major depression as they enter treatment, and to track the differences in family relationships for adolescents who respond or do not respond. We postulate that tense, frustrated, irritable, and over-involved relationships constitute a risk factor for attenuated improvement or relapse.

Timeline

Start
2006-01
Primary completion
2007-02
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluoxetine Small molecule
Subject Lamotrigine Small molecule
Subject Sertraline Small molecule

Indications

No indication recorded.