Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00211861 |
This study will evaluate the effectiveness of the Nk1 antagonist, GR205171, as compared to placebo, in improving overall PTSD symptoms.
Condition | Intervention | Phase |
---|---|---|
Stress Disorders Post-Traumatic Stress Disorder |
Drug: NK1 antagonist GR205171 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effectiveness of an NK1 Antagonist in PTSD |
Estimated Enrollment: | 52 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Participants will take placebo
|
Drug: Placebo
5 mg capsule, taken orally once per day for 8 weeks
|
2: Experimental
Participants will take the study drug GR205171
|
Drug: NK1 antagonist GR205171
5 mg capsule, taken orally once per day for 8 weeks
|
This is a 10-week, double-blind, placebo-controlled trial of an NK1 antagonist, GR205171, in post traumatic stress disorder.
The purposes of the study are:
People with PTSD between the ages of 18 and 65 may be eligible for this study. Potential participants receive a thorough psychiatric and medical screening, and if found eligible, enter into the 10-week trial. Participants must be free of psychotropic medications for at least 2 weeks prior to the beginning of the 10 weeks.
There are weekly in-person visits throughout the study, where study physicians evaluate the participant's progress and monitor the occurrence of side effects, and participants have blood drawn for safety lab tests.
Participants have the option of participating in an MRI and lumbar puncture both during the first 2 weeks of the study and at the end of the 2 weeks.
Post-traumatic stress disorder (PTSD) is a chronic and common anxiety disorder that follows exposure to an overwhelming traumatic event. The majority of patients with PTSD also meet criteria for other psychiatric disorders, and many attempt suicide. Despite its impact on society, little is known about the etiology or pathophysiology of this disorder. PTSD is responsive to pharmacological treatments such as selective serotonin reuptake inhibitors (SSRIs), but response rates rarely exceed 60%, and even fewer patients (20-30%) achieve clinical remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD.
A growing body of preclinical studies suggests that activation of substance P (SP) and its NK1 receptor is anxiogenic and that NK1 antagonists, with chronic administration, exert significant dampening effects on this system. SP is a neuropeptide belonging to the tachykinin family, and has been implicated in several neurological and psychiatric illnesses. Excess activity of the SP-NK1 system thus stands as a prime candidate for involvement in the pathophysiology of anxiety disorders such as PTSD.
We propose to investigate the efficacy of the highly specific NK1 antagonist GR205171 in PTSD in a placebo-controlled clinical trial. Furthermore, we propose to investigate whether certain biological surrogate markers (neuroendocrine and neuroimaging) are predictive of treatment response. If a patient is already taking medication for PTSD and has achieved therapeutic response, he/she will not be tapered off effective medication(s) to participate in this study, and will not be eligible for the study. Taper and discontinuation of medications in preparation for this study will only occur in those patients who are not responding to medication treatment for PTSD.
Hypotheses:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Douglas Brodman | douglas.brodman@mssm.edu |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029-6574 | |
Contact: Douglas Brodman 212-241-6603 douglas.brodman@mssm.edu | |
Principal Investigator: Dennis Charney, MD |
Principal Investigator: | Dennis Charney, MD | Mount Sinai School of Medicine |
Responsible Party: | Mount Sinai School of Medicine ( Dennis Charney, MD ) |
Study ID Numbers: | U19 MH06905 |
Study First Received: | September 15, 2005 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00211861 |
Health Authority: | United States: Food and Drug Administration |
Post Traumatic Stress Disorder Phase II Clinical Trial NK1 Antagonist Treatment |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic |
Stress GR 205171 Stress Disorders, Traumatic |
Pathologic Processes Disease |