Lamotrigine in Treatment Resistant Depression in Adolescents
Status:
Terminated
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
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.