Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression
Completed
National Institute of Mental Health (NIMH)
Phase 2
2002-04-01
The purpose of this study is to evaluate the safety and effectiveness of the drug felbamate
for treating depression in patients with bipolar disorder that has not responded to standard
treatments.
Bipolar disorder is a severe, chronic, and often life-threatening illness. Despite the
availability of a wide range of antidepressant drugs, a proportion of patients fail to
respond to first-line antidepressant treatment despite adequate dosage, duration, and
compliance. Studies suggest that the glutamatergic system may play a role in the
pathophysiology and treatment of depression. Felbamate and other agents which reduce
glutamatergic neurotransmission may represent a novel class of antidepressants.
Participants in this study will be admitted to the Clinical Center for up to 10 weeks. At
study entry, participants will have a 7-day washout period in which they will be tapered off
all psychiatric medications, with the possible exception of lithium, and will be given a
placebo (an inactive pill). After the washout period, participants will be randomly assigned
to receive either felbamate or placebo for 8 weeks. Participants whose depression symptoms
worsen by more than 30% or those for whom study continuation is considered potentially
harmful will be taken off the study and offered open-label treatment. Participants who
received felbamate and responded well to treatment will have the option of continuing
treatment.
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