Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 9/30/2018 |
| Start Date: | September 18, 2017 |
| End Date: | February 1, 2019 |
| Contact: | Jaime Hatcher-Martin, MD, PhD |
| Email: | jmhatch@emory.edu |
| Phone: | 404-712-7274 |
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.
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.
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.
Inclusion Criteria:
- age 18-75 years
- diagnosis of classical TD by a movement disorder expert for at least 6 months with a
baseline score of at least 2 on two of the seven items on the AIMS severity scale
- stable on medication (either on or off dopamine blocking agents) for at least six
months.
Exclusion Criteria:
- breastfeeding
- pregnant
- unstable psychiatric disease
- history of asthma or COPD
- baseline heart rate less than 60
- history of orthostatic hypertension or its presence at screening
- history of congestive heart failure or unstable angina pectoris
- resting SBP <100 and DBP < 60
- AV-block II or III without pacemaker
- history of diabetes mellitus
- previous adverse effects from use of beta-blockers
- current use of a β-blocker and the other following drugs: quinidine, amiodarone,
propafenone, digoxin, verapamil, diltiazem, clonidine, and warfarin
- tremor, dystonia, akathisia or other non-tardive movement disorder
- any medical illness that precludes treatment with propranolol.
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