A Phase 2 interventional study of Xyrem in PTSD and Anxiety, Post Traumatic, sponsored by State University of New York - Upstate Medical University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-07.
Sponsored by State University of New York - Upstate Medical University · Phase 2, Interventional, and Treatment
Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy (sleep attacks). It has been shown to be a safe and effective agent here where deep, restorative slow wave sleep improves and next day cataplexy attacks tend not to occur.
Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed or been involved in a traumatic event. After the event is over, nightmares, flashbacks, avoidance of people and places associated with trauma and hyperarousal occur which is incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to remit as they continue to have sleep problems. PTSD patients will often fail to respond to antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia due to PTSD.
The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed usual PTSD treatments and have failed usual insomnia treatments in particular will be given Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is a safe treatment optionin this difficult-to-treat patient population.
This is an open-label (no placebo) study to see if the addition of Xyrem to a subject's PTSD medication regimen will be tolerated and possibly improve insomnia. Subjects will currently be taking at least a single psychotropic agent for the treatment of PTSD, (an SSRI). Dosing will be stable for at least 4 weeks and subjects will need to report continued insomnia despite treatment. They must also have failed at least two insomnia augmentations from separate drugs classes (benzodiazepine (temezapam, zolpidem, ect.), antihistime (quetiapine, mirtazapine, trazadone, etc.), dopamine antagonist (olanzapine, quetiapine, aripiprazole, etc.) to qualify for refractory insomnia.
Subjects will complete consenting process and attend a screening visit where they will be given a MINI psychiatric diagnostic evaluation to confirm PTSD, be given a Hamilton Anxiety, a Hospital Anxiety \& Depression Scale, PCL-C, Fatigue Severity Scale, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Inventory, SF-12, and sleep diary evaluation to delineate current anxiety levels (secondary measure). Subjects will have to offer consent for the study team to contact their primary providers and retrieve all past and present records to show refractory history and lack of substance abuse. Subjects will undergo a brief physical exam and bloodwork and a sleep EEG will be ordered. Furthermore, a urine drug screen will be used to screen for current misuse. If subjects are taking sleeping agents, they will be appropriately washed out (tapered per cusual clinical practice and then drug free 5 times the drug's half life) prior to sleep EEG and prior to Xyrem start. In clinical practice, Xyrem use does not warrant blood monitoring, EEGs or EKGs per the FDA.
Assuming subject meets eligibility, they will start Xyrem per cataplexy dosing guidelines. Prior to titration, a 1-2 week washout of any sleeping agent will occur. Titration will then start with 2.25g at bedtime and then again 4 hours later. This drug may be flexibly increased to 4.5g (x2 doses) based upon tolerability and effectiveness. We will escalate dose if drug is toleratedbut without efficacy. Dosing will be increased if subjective sleep quantity/quality is still reported to be unchanged or if our rating scales indicate minimal to no change.
After screening visit 1 (eligibility, medical safety determination, washout, sleep EEG) subjects will return for baseline Visit 2 and start Xyrem.
They will be seen for Visit 3 after 7 days of treatment for rating scales and possible dose escalation to 6g/d.
They will be seen for Visit 4 after 14 days of treatment for rating scales and possible dose escalation to 7.5g/d.
They will be seen for Visit 5 after 21 days of treatment for rating scales and possible dose escalation to 9g/d.
They will be seen for Visit 6/termination after 28 days of treatment for rating scales, physical exam, lab work, sleep EEG.
Subjects will be called for final safety follow up one week later and 12 weeks later.
Again, liaison with the subject's provider will occur to discuss continuance of Xyrem. If provider agrees, then long term monitoring will be in the jurisdiction of this provider. If agreement is to NOT continue Xyrem, patient will be tapered or offered help in finding a clinician comfortable with the drug. There is no major issue in stopping this drug from a withdrawal point of view as it does not build up in the system over time in regards to dependence when used at bed time only. Insomnia will likely return and patient would go back to their usual treatment if desired and most likely their original level of insomnia.
Safety Measures The overall safety and tolerability of Xyrem will be assessed throughout the study by adverse event recording, clinical laboratory test results and physical exams. A Safety monitoring board will consist of the PI and two psychiatry attendings from University Hospital
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →State University of New York - Upstate Medical University is the lead sponsor of 154 studies on the registry; 17 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
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Inclusion Criteria:Patients are included in the study if all of the following criteria are met:
The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
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Exclusion Criteria:Patients are excluded from participating in this study if 1 or more of the following criteria are met:
(k) The patient is unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator.
(l) The patient has a clinically significant deviation from normal in the physical examination.
(m) The patient has a responsibility that would require them to wake up and perform within 4 hours of a Xyrem dose (n) The patient refuses to cease use of sleeping pills (o) The patient has been diagnosed with sleep apnea (we will clinically prescreen for this and check on initial EEG).
(p) If the patient lives alone, they will need to agree to being called by a member of the study team to assess the subject's well being on the morning after the first ingestion of study drug and on the morning after any dose increase to monitor for excess sedation, sleepwalking, etc. (q) If the patient lives with children less than 6 years of age, they will not be allowed in the study.
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State University of New York - Upstate Medical University