Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

This study has been completed.

First Received: January 18, 2006 Last Updated: March 12, 2009 History of Changes

Sponsor:	Lindner Center of HOPE
Collaborators:	UCB, Inc. University of Cincinnati
Information provided by:	Lindner Center of HOPE
ClinicalTrials.gov Identifier:	NCT00279617

Purpose

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.

Condition	Intervention	Phase
Panic Disorder	Drug: levetiracetam	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

Resource links provided by NLM:

MedlinePlus related topics: Panic Disorder

Drug Information available for: Levetiracetam

U.S. FDA Resources

Further study details as provided by Lindner Center of HOPE:

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Outpatient subjects age 18 years or older.
Subjects must meet DSM-IV-TR criteria for panic disorder with or without agoraphobia.
Subjects must experience a minimum of one panic attack per week over the month preceding the study.
Subjects must be fluent in English.
Subjects must be able to provide and understand written informed consent.

Exclusion Criteria:

Subjects unable to provide and understand written informed consent.
Subjects previously treated with levetiracetam.
Subjects who meet DVM-IV-TR criteria for current diagnosis of mood, psychotic or substance use disorder.
Subjects who have acute or unstable medical illness.
Subjects with a history of seizures or structural brain damage from trauma.
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).
Subjects susceptible to lactate infusions.
Female subjects who are pregnant or lactating.
Female subjects who, if fertile, are not using medically acceptable and reliable method of contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279617

Locations

United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559

Sponsors and Collaborators

Lindner Center of HOPE

UCB, Inc.

University of Cincinnati

Investigators

Principal Investigator:

Paul Keck, MD

University of Cincinnati

More Information

No publications provided

Study ID Numbers:	2-Miefert
Study First Received:	January 18, 2006
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00279617 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Nootropic Agents
Disease
Physiological Effects of Drugs
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Panic Disorder
Pathologic Processes

Anxiety Disorders
Mental Disorders
Therapeutic Uses
Piracetam
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009