Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

This study has been completed.
Sponsor:
Collaborators:
UCB Pharma
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00279617
First received: January 18, 2006
Last updated: December 12, 2011
Last verified: December 2011
  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 3

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:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pharma
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
Disease
Anxiety Disorders
Mental Disorders
Pathologic Processes
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 October 19, 2014