Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

This study has been completed.

First Received on January 18, 2006. Last Updated on December 12, 2011 History of Changes

Sponsor:	Lindner Center of HOPE
Collaborators:	UCB, Inc. University of Cincinnati
Information provided by (Responsible Party):	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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Levetiracetam

U.S. FDA Resources

Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:

Hamilton Anxiety scale (HAM-A) [ Time Frame: each visit ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	January 2006
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Levetricetam open label treatment	Drug: levetiracetam open label levetricetam Other Name: Keppra

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Responsible Party:	Lindner Center of HOPE
ClinicalTrials.gov Identifier:	NCT00279617 History of Changes
Other Study ID Numbers:	2-Miefert
Study First Received:	January 18, 2006
Last Updated:	December 12, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Panic Disorder
Anxiety Disorders
Mental Disorders
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012