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| Sponsor: | State University of New York - Upstate Medical University |
|---|---|
| Information provided by: | State University of New York - Upstate Medical University |
| ClinicalTrials.gov Identifier: | NCT00330291 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
PTSD Anxiety, Post Traumatic |
Drug: Xyrem |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Xyrem for Treatment Refractory Insomnia Due to PTSD |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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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Contacts and Locations| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Principal Investigator: | Thomas L Schwartz, MD | State University of New York - Upstate Medical University |
More Information
| Study ID Numbers: | 4975 |
| Study First Received: | May 24, 2006 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00330291 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
PTSD Xyrem Sleep problems |
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Anesthetics, Intravenous Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Stress Disorders, Traumatic Pharmacologic Actions Adjuvants, Anesthesia |
Anxiety Disorders Mental Disorders Anesthetics, General Therapeutic Uses Stress Disorders, Post-Traumatic Central Nervous System Agents Sodium Oxybate |