Tardive Dyskinesia Clinical Trial
Official title:
Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia
Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic
movement disorder that can occur in anyone exposed to drugs that block dopamine receptors,
including first and second generation antipsychotics and antiemetic agents. There is no way
to prevent TD except preventing exposure to the inciting agents and there are no approved
symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting
its use as a treatment for TD.
The goal of this study is to determine the efficacy of propranolol in the treatment of TD in
a double-blind, cross-over prospective manner. If propranolol is found to be an effective
therapy, it will fulfill a great need in the treatment of TD with a medication that is known
to be safe and inexpensive.
Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic
movement disorder that can occur in anyone exposed to drugs that block dopamine receptors,
including first and second generation antipsychotics and antiemetic agents. There is no way
to prevent TD except preventing exposure to the inciting agents and there are no approved
symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting
its use as a treatment for TD.
The goal of this study is to determine the efficacy of propranolol in the treatment of TD in
a double-blind, cross-over prospective manner. Patients with a diagnosis of TD will be
randomized to propranolol or identical placebo. The patients will be treated for eight weeks,
complete a one week washout and then crossed over for another eight weeks. Hence, the
subjects will be their own controls. Participation in this pilot trial will provide placebo
controlled blinded data that will assist in planning a larger phase II trial. If propranolol
is found to be an effective therapy, it will fulfill a great need in the treatment of TD with
a medication that is known to be safe and inexpensive.
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