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Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

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ClinicalTrials.gov Identifier: NCT00279617
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : December 13, 2011
Sponsor:
Collaborators:
UCB Pharma
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Panic Disorder Drug: levetiracetam Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks
Study Start Date : January 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Levetricetam
open label treatment
 Drug: levetiracetam
open label levetricetam
Other Name: Keppra


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Anxiety scale (HAM-A) [ Time Frame: each visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00279617     History of Changes
Other Study ID Numbers: 2-Miefert
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Etiracetam
 Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs