Track topics on Twitter Track topics that are important to you
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.
a) Methods and Procedures:
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 mg/d will be discontinued from the trial
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.
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. Inclusion/exclusion 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 inclusion/exclusion 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 0.5 mol/L sodium DL-lactate (at body temperature) is initiated. The total dose (10 ml/kg 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 0.5 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.
Allocation: Non-Randomized, Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
University of Cincinnati Medical Center
Lindner Center of HOPE
Published on BioPortfolio: 2014-07-23T21:46:28-0400
Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal g...
This study is designed to observe the effects of a panic attack in patients with panic disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby, further o...
The purpose of this study is to assess the impact of three different treatment modalities on panic symptoms, quality of life and use of health services among individuals consulting an emer...
The purpose of this study is to provide some information (pilot data) about whether the study drug, suvorexant, (1) affects levels of orexin in people with panic disorder, and (2) is assoc...
The purpose of these questionnaires is to give us an overview of how panic has affected your life and perhaps also to give us some clues about things that may have set you up to experience...
Computer simulations (CS) and virtual reality exposure are promising techniques for research and treatment of panic disorder with agoraphobia (PDA). The objective of this study was to ascertain whethe...
Panic disorder (PD) is a prevalent and highly disabling mental condition. However, less is known about relationships between biomarkers that may together predict a better response to pharmacological t...
Anxiety disorders including panic disorder (PD) are the most prevalent psychiatric diseases leading to high disability and burden in the general population. Acute panic attacks are distinctive for PD ...
Ascertaining comorbid illnesses and patterns of medical utilization early in the course of psychiatric illness can help identify patients with panic disorder. We investigated how such cases were diagn...
Subjects with panic disorder are nearly 4 times as likely to attempt suicide as compared to subjects without this condition.
A type of anxiety disorder characterized by unexpected panic attacks that last minutes or, rarely, hours. Panic attacks begin with intense apprehension, fear or terror and, often, a feeling of impending doom. Symptoms experienced during a panic attack include dyspnea or sensations of being smothered; dizziness, loss of balance or faintness; choking sensations; palpitations or accelerated heart rate; shakiness; sweating; nausea or other form of abdominal distress; depersonalization or derealization; paresthesias; hot flashes or chills; chest discomfort or pain; fear of dying and fear of not being in control of oneself or going crazy. Agoraphobia may also develop. Similar to other anxiety disorders, it may be inherited as an autosomal dominant trait.
An MAO inhibitor that is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in the treatment of panic disorder and the phobic disorders. (From AMA, Drug Evaluations Annual, 1994, p311)
A propylamine formed from the cyclization of the side chain of amphetamine. This monoamine oxidase inhibitor is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in panic and phobic disorders. (From AMA Drug Evaluations Annual, 1994, p311)
Compounds that specifically inhibit the reuptake of serotonin in the brain. This increases the serotonin concentration in the synaptic cleft which then activates serotonin receptors to a greater extent. These agents have been used in treatment of depression, panic disorder, obsessive-compulsive behavior, and alcoholism, as analgesics, and to treat obesity and bulimia. Many of the ADRENERGIC UPTAKE INHIBITORS also inhibit serotonin uptake; they are not included here.
A neuropsychiatric disorder characterized by one or more of the following essential features: immobility, mutism, negativism (active or passive refusal to follow commands), mannerisms, stereotypies, posturing, grimacing, excitement, echolalia, echopraxia, muscular rigidity, and stupor; sometimes punctuated by sudden violent outbursts, panic, or hallucinations. This condition may be associated with psychiatric illnesses (e.g., SCHIZOPHRENIA; MOOD DISORDERS) or organic disorders (NEUROLEPTIC MALIGNANT SYNDROME; ENCEPHALITIS, etc.). (From DSM-IV, 4th ed, 1994; APA, Thesaurus of Psychological Index Terms, 1994)
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...