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Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT00383786
Recruitment Status : Completed
First Posted : October 4, 2006
Results First Posted : January 31, 2014
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sanjay Johan Mathew, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition PTSD
Interventions 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
Enrollment 47

Recruitment Details Patients (aged 18–65) were recruited from media advertisement (86%) or clinician referral (14%). Diagnoses were made with the SCID-IV performed by an experienced research clinician, along with an independent interview by a psychiatrist. A primary diagnosis of chronic PTSD, signifying an illness duration.
Pre-assignment Details Of 235 potential participants screened for eligibility, 171 (73%) were excluded prior to placebo lead-in. 128 did not meet eligibility criteria, 24 were lost to follow-up, and 19 withdrew consent. Sixty-four patients began placebo lead-in, of whom 47 patients (73%) were randomized (11 were ineligible and 6 withdrew consent).
Arm/Group Title GR205171 Placebo
Hide Arm/Group Description selective neurokinin-1 receptor antagonist, 5mg/day for a period of 8 weeks sugar pill administered daily for a period of 8 weeks
Period Title: Overall Study
Started 22 25
Completed 18 13
Not Completed 4 12
Reason Not Completed
Protocol Violation             2             6
Withdrawal by Subject             2             5
Physician Decision             0             1
Arm/Group Title GR205171 Placebo Total
Hide Arm/Group Description selective neurokinin-1 receptor antagonist sugar pill Total of all reporting groups
Overall Number of Baseline Participants 22 25 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 25 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
25
 100.0%
47
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 25 participants 47 participants
43.0  (11.5) 38.7  (12.3) 40.9  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 25 participants 47 participants
Female
12
  54.5%
11
  44.0%
23
  48.9%
Male
10
  45.5%
14
  56.0%
24
  51.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 25 participants 47 participants
22 25 47
1.Primary Outcome
Title Changes in CAPS Scores.
Hide Description The Clinician-Administered PTSD Scale (CAPS) is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. This is a 17-item core symptom scale, measuring both frequency and intensity of symptoms, with the most frequently used scoring rule is to count a symptom as present if it has a frequency of 1 or more and an intensity of 2 or more. A PTSD diagnosis is made if there is at least 1 "B" symptom, 3 "C" symptoms, and 2 "D" symptoms as well as meeting the other diagnostic criteria. Scores range from 0-136 0 (best possible outcome) to 136 (worst possible outcome). The relevant time-points for reporting change were at baseline and 8 weeks.
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
20 patients randomized to drug were included in the primary analysis as 2 our of the 22 randomized were excluded because they did not receive a week 1 assessment. 19/25 randomized to placebo were included in the analysis after 6 were excluded due to not receiving week 1 assessments.
Arm/Group Title GR205171 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: scores on a scale
43.5  (5.1) 51.1  (5.7)
2.Secondary Outcome
Title Able to Identify Biological Markers That Predict Response to Treatment.
Hide Description [Not Specified]
Time Frame 10 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GR205171 Placebo
Hide Arm/Group Description selective neurokinin-1 receptor antagonist sugar pill
All-Cause Mortality
GR205171 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GR205171 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GR205171 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/22 (59.09%)   6/25 (24.00%) 
Nervous system disorders     
Headache   13/22 (59.09%)  6/25 (24.00%) 
Indicates events were collected by systematic assessment
Limitations include the small sample size and brief duration of the trial, as 8 weeks might have been insufficient to test the efficacy of GR205171 for chronic PTSD. Sample size was also a limitation.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sanjay Mathew, MD/PI
Organization: Baylor College of Medicine
Phone: 7137985439
Responsible Party: Sanjay Johan Mathew, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00383786     History of Changes
Obsolete Identifiers: NCT00211861
Other Study ID Numbers: 060253
06-M-0253
First Submitted: October 3, 2006
First Posted: October 4, 2006
Results First Submitted: September 5, 2013
Results First Posted: January 31, 2014
Last Update Posted: February 13, 2018