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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00383786 |
This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD).
People between 18 and 65 years of age who have been diagnosed with PTSD may be eligible for this study. Participants undergo the following tests and procedures:
Treatment: Patients are tapered off current ineffective medications over 1 to 2 weeks. All participants receive placebo (sugar pill) at the start of the study. At some point within the first 3 weeks of the study, they are then randomly assigned either to take GR205171 or to continue with placebo for the remainder of the 10-week treatment period.
Clinic visits: Patients come to the clinic once a week during treatment. The following procedures are done at various visits.
Follow-up visits continue for up to 3 months after the end of the study, during which patients are offered standard clinical treatment.
Condition | Intervention | Phase |
---|---|---|
PTSD |
Drug: NK1 Antagoist (GR205171) Procedure: Psychophysiology (Trauma Script) Procedure: Psychophysiology (Verbal Threat) Procedure: Psychophysiology (Fear Conditioning) Procedure: Psychophysiology (Affective Modulation) Procedure: Psychophysiology (Heart rate variability) Procedure: Lumbar Puncture Procedure: 24-hour plasma sampling Procedure: MRI Device: GR205171 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of the Efficacy of the NK1 Antagonist GR205171 in Posttraumatic Stress Disorder |
Estimated Enrollment: | 52 |
Study Start Date: | September 2006 |
Posttraumatic Stress Disorder (PTSD) is a common chronic anxiety disorder that is often debilitating and follows exposure to an overwhelming traumatic event. The burden of PTSD on individuals and society is significant. The majority of PTSD sufferers also meet the diagnostic criteria for several other psychiatric disorders and many attempt suicide. Despite the devastating impact of PTSD on the lives of millions worldwide, little is known about the etiology or pathophysiology of this disorder. Although disruptions in the hypothalamic-pituitary adrenal (HPA) Axis, noradrenergic, serotonergic systems have been proposed as neurobiological substrates in the development of PTSD, the exact underpinnings of the neurobiology of PTSD remain to be fully elucidated.
PTSD is responsive to treatment with selective serotonin reuptake inhibitors, but response rates rarely exceed 60%, and even fewer patients (20%-30%) experience improvement that could be characterized as remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD. A growing body of preclinical evidence suggests that activation of the Substance P (SP) and its receptor NK1 is anxiogenic and that NK1 antagonists, upon chronic administration, exert significant dampening (albeit complex) effects on the SP-NP system. Furthermore, several stress paradigms are believed to exert many of their deleterious effects on hippocampal structures via enhancement of SP-NK1 system. Overall, excess activity of the SP-NK1 system stands as a prime candidate for involvement in the pathophysiology of anxiety disorders such as PTSD.
In this study, we propose to investigate the potential antianxiety efficacy of the highly specific NK1 antagonist GR205171 in PTSD. Furthermore, we propose to, in a preliminary fashion, longitudinally investigate whether neuroendocrine surrogate markers are predictive of treatment response.
This is an 8-week double-blind placebo-controlled study that will examine the efficacy and safety of an NK1 antagonist in patients with PTSD.
Patients, ages 18 to 65 years with a diagnosis of PTSD, will in this pilot study be randomized to double-blind treatment to receive either the NK1 antagonist, GR205171 (5 mg/day) or placebo for a period of 8 weeks.
Approximately 52 patients will enter the study to obtain 40 subjects who complete the 8 weeks of acute NK1 antagonist treatment.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Subjects may be included in the study only if they meet all of the following criteria:
EXCLUSION CRITERIA:
Subjects will be excluded from the study for any of the following reasons:
Patients will not be allowed to receive structured psychotherapy during the trial.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
United States, New York | |
Mt. Sinai Medical Center | Recruiting |
New York, New York, United States, 10029-0574 |
Responsible Party: | ( Sanjay J. Matthew, M.D. ) |
Study ID Numbers: | 060253, 06-M-0253 |
Study First Received: | October 3, 2006 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00383786 |
Health Authority: | United States: Federal Government |
PTSD Substance P Treatment Study Placebo |
Controlled Post Traumatic Stress Disorder PTSD |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress |
GR 205171 Substance P Stress Disorders, Traumatic |
Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Gastrointestinal Agents |
Antiemetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |