Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks
This study has been completed.
Sponsor:
Lindner Center of HOPE
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
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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:
- 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
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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
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:
|
Disease Panic Disorder Anxiety Disorders Mental Disorders Pathologic Processes Etiracetam Piracetam Anticonvulsants |
Central Nervous System Agents Neuroprotective Agents Nootropic Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015