Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00383786
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2006-10-03
Brief Title:
Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Evaluation of the Efficacy of the NK1 Antagonist GR205171 in Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Interviews self report questionnaires and psychiatric rating scales at every visit
Physical examination blood and urine tests Blood is drawn up to 10 times during the study
Follow-up visits continue for up to 3 months after the end of the study during which patients are offered standard clinical treatment
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
Interviews self report questionnaires and psychiatric rating scales at every visit
Physical examination blood and urine tests Blood is drawn up to 10 times during the study
Follow-up visits continue for up to 3 months after the end of the study during which patients are offered standard clinical treatment
Detailed Description:
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 mgday 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
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 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-M-0253 | None | None | None |