Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279617
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2006-01-18
Brief Title:
Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks
Sponsor:
Lindner Center of HOPE
Organization:
Lindner Center of HOPE
Study Overview
Official Title:
Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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
Detailed Description:
a Methods and Procedures
Study Treatment
Study drug and dosing Levetiracetam open-label with the following titration schedule to begin after the initial lactate infusion
Study day Levetiracetam dose 1-4 250 mg 5-7 500 mg 8-10 750 mg 11-14 1000 mg 15-18 1500 mg 19-21 2000 mg 22-25 2500 mg 26-28 3000 mg 29-56 3000 mg
Levetiracetam will be titrated to maximized clinical response total reduction of panic attacks and intervening anxiety and minimize side effects Subjects who develop bothersome side effects will be permitted to have a dose reduction to alleviate such side effects Subjects unable to tolerate levetiracetam 500 mgd will be discontinued from the trial
Study Design
This is an 8 week open-label trial of the antiepileptic agent levetiracetam in the treatment of subjects who meet DSM-IV-TR criteria for panic disorder In addition prior to and at the conclusion of the open-label trial subjects will participate in a 1 hour intravenous IV lactate infusion to determine whether levetiracetam administration blocks lactate-induced panic attacks
Study procedures
Screening Visit 1 Subjects will provide written informed consent after an explanation of all study procedures The Structured Interview for DSM-IV anxiety disorder module will be administered to confirm the diagnosis of panic disorder A complete psychiatric and medical history will be obtained and a physical examination including vital signs will be performed Subjects must experience a minimum of one panic attack per week over the month preceding the study Inclusionexclusion criteria will be reviewed and subjects will be assessed for compliance with these criteria Subjects will be given a panic attack diary to record the number of panic attacks they experience each day Subjects will be given the API All female subjects who are able to have children will have a blood sample drawn for laboratory evaluation of β HCG Subjects will be asked to return in one week
Baseline Visit 2 Subjects will return their completed panic attack diary Subjects will then be administered the HAM-A rating scale Vital signs will be recorded Subjects who continue to meet inclusionexclusion criteria will undergo the 1 hour lactate infusion
Infusion procedure Subjects will be recumbent in bed and made comfortable In intravenous line will be placed in the antecubital fossa and a slow intravenous infusion of 5 dextrose in water D5W will be administered for 28 minutes then accelerated for 2 min to mimic subsequent lactate infusion The intravenous solution will be out of view of the subject behind a bedside screen Subjects are blind to the timing of lactate administration At time 0 after 30 min of D5W infusion an infusion of 05 molL sodium DL-lactate at body temperature is initiated The total dose 10 mlkg body weight is administered over the subsequent 20 min unless the subject experiences a panic attack in which case the lactate infusion is immediately discontinued At the time of panic symptoms or at the end of 20 min the subject is switched back to D5W for 5 min followed by termination of the infusion
Subjective symptoms of a panic attack will be assessed using the 28-item Acute Panic Inventory The API will administered at the conclusion of the screening interview during which time they will be asked to describe a typical panic attack prior to infusion of D5W prior to lactate infusion halfway through lactate infusion 10 min into the infusion and if precipitated at the emergence of a panic attack To meet criteria for having a panic attack a subject must experience a crescendo of anxiety fear or apprehension and at least 4 of the physical symptoms listed in DSM-IV-TR for a panic attack Subjects who experience a panic attack will be offered lorazepam 05 mg po to alleviate panic attack symptoms
Subjects will begin open-label treatment with levetiracetam following the initial lactate infusion Levetiracetam will be titrated according to the schedule described above
Subjects who do not experience a lactate induced panic attack at baseline will be eliminated from the study
Day 7 Visit 3 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded Study medication will be reviewed for adherence Study medication will be dispensed
Day 14 Visit 4 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded Study medication will be reviewed for adherence Study medication will be dispensed
Day 28 Visit 5 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded Study medication will be reviewed for adherence Study medication will be dispensed
Day 42 Visit 6 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded Study medication will be reviewed for adherence Study medication will be dispensed
Day 56 Visit 7 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded
Subjects will repeat the lactate infusion procedure as described in Visit 2 At the conclusion of the second lactated infusion subjects who have responded to treatment with levetiracetam will be offered up to 3 months continued treatment with levetiracetam and office visits at no charge until subjects are appropriately referred for continued follow-up treatment Subjects not responding to levetiracetam treatment will be offered treatment with an FDA-approved medication for panic disorder
Study Treatment
Study drug and dosing Levetiracetam open-label with the following titration schedule to begin after the initial lactate infusion
Study day Levetiracetam dose 1-4 250 mg 5-7 500 mg 8-10 750 mg 11-14 1000 mg 15-18 1500 mg 19-21 2000 mg 22-25 2500 mg 26-28 3000 mg 29-56 3000 mg
Levetiracetam will be titrated to maximized clinical response total reduction of panic attacks and intervening anxiety and minimize side effects Subjects who develop bothersome side effects will be permitted to have a dose reduction to alleviate such side effects Subjects unable to tolerate levetiracetam 500 mgd will be discontinued from the trial
Study Design
This is an 8 week open-label trial of the antiepileptic agent levetiracetam in the treatment of subjects who meet DSM-IV-TR criteria for panic disorder In addition prior to and at the conclusion of the open-label trial subjects will participate in a 1 hour intravenous IV lactate infusion to determine whether levetiracetam administration blocks lactate-induced panic attacks
Study procedures
Screening Visit 1 Subjects will provide written informed consent after an explanation of all study procedures The Structured Interview for DSM-IV anxiety disorder module will be administered to confirm the diagnosis of panic disorder A complete psychiatric and medical history will be obtained and a physical examination including vital signs will be performed Subjects must experience a minimum of one panic attack per week over the month preceding the study Inclusionexclusion criteria will be reviewed and subjects will be assessed for compliance with these criteria Subjects will be given a panic attack diary to record the number of panic attacks they experience each day Subjects will be given the API All female subjects who are able to have children will have a blood sample drawn for laboratory evaluation of β HCG Subjects will be asked to return in one week
Baseline Visit 2 Subjects will return their completed panic attack diary Subjects will then be administered the HAM-A rating scale Vital signs will be recorded Subjects who continue to meet inclusionexclusion criteria will undergo the 1 hour lactate infusion
Infusion procedure Subjects will be recumbent in bed and made comfortable In intravenous line will be placed in the antecubital fossa and a slow intravenous infusion of 5 dextrose in water D5W will be administered for 28 minutes then accelerated for 2 min to mimic subsequent lactate infusion The intravenous solution will be out of view of the subject behind a bedside screen Subjects are blind to the timing of lactate administration At time 0 after 30 min of D5W infusion an infusion of 05 molL sodium DL-lactate at body temperature is initiated The total dose 10 mlkg body weight is administered over the subsequent 20 min unless the subject experiences a panic attack in which case the lactate infusion is immediately discontinued At the time of panic symptoms or at the end of 20 min the subject is switched back to D5W for 5 min followed by termination of the infusion
Subjective symptoms of a panic attack will be assessed using the 28-item Acute Panic Inventory The API will administered at the conclusion of the screening interview during which time they will be asked to describe a typical panic attack prior to infusion of D5W prior to lactate infusion halfway through lactate infusion 10 min into the infusion and if precipitated at the emergence of a panic attack To meet criteria for having a panic attack a subject must experience a crescendo of anxiety fear or apprehension and at least 4 of the physical symptoms listed in DSM-IV-TR for a panic attack Subjects who experience a panic attack will be offered lorazepam 05 mg po to alleviate panic attack symptoms
Subjects will begin open-label treatment with levetiracetam following the initial lactate infusion Levetiracetam will be titrated according to the schedule described above
Subjects who do not experience a lactate induced panic attack at baseline will be eliminated from the study
Day 7 Visit 3 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded Study medication will be reviewed for adherence Study medication will be dispensed
Day 14 Visit 4 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded Study medication will be reviewed for adherence Study medication will be dispensed
Day 28 Visit 5 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded Study medication will be reviewed for adherence Study medication will be dispensed
Day 42 Visit 6 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded Study medication will be reviewed for adherence Study medication will be dispensed
Day 56 Visit 7 The HAM-A will be administered and panic attack diaries will be reviewed and recorded Adverse events will be reviewed Vital signs will be recorded
Subjects will repeat the lactate infusion procedure as described in Visit 2 At the conclusion of the second lactated infusion subjects who have responded to treatment with levetiracetam will be offered up to 3 months continued treatment with levetiracetam and office visits at no charge until subjects are appropriately referred for continued follow-up treatment Subjects not responding to levetiracetam treatment will be offered treatment with an FDA-approved medication for panic disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None