Overview

Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this research study is to determine whether the drug Levetiracetam (Keppra™) is effective in the prevention of panic attacks. The drug Levetiracetam (Keppra™) has been approved for the treatment of seizures by the U.S. Federal Food and Drug Administration (FDA) and is available by prescription. Levetiracetam has not been approved by the FDA for the treatment of panic disorder.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lindner Center of HOPE
Collaborators:
UCB Pharma
University of Cincinnati
Treatments:
Etiracetam
Levetiracetam
Piracetam
Criteria
Inclusion Criteria:

1. Outpatient subjects age 18 years or older.

2. Subjects must meet DSM-IV-TR criteria for panic disorder with or without agoraphobia.

3. Subjects must experience a minimum of one panic attack per week over the month
preceding the study.

4. Subjects must be fluent in English.

5. Subjects must be able to provide and understand written informed consent.

Exclusion Criteria:

1. Subjects unable to provide and understand written informed consent.

2. Subjects previously treated with levetiracetam.

3. Subjects who meet DVM-IV-TR criteria for current diagnosis of mood, psychotic or
substance use disorder.

4. Subjects who have acute or unstable medical illness.

5. Subjects with a history of seizures or structural brain damage from trauma.

6. Subjects currently receiving successful treatment for panic disorder (i.e., subjects
will not have medications discontinued to participate in the study if they are
effective in the treatment of their panic attacks).

7. Subjects susceptible to lactate infusions.

8. Female subjects who are pregnant or lactating.

9. Female subjects who, if fertile, are not using medically acceptable and reliable
method of contraception.