Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383786
Recruitment Status : Completed
First Posted : October 4, 2006
Results First Posted : January 31, 2014
Last Update Posted : February 13, 2018
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
GR205171 selective neurokinin-1 receptor antagonist, 5mg/day for a period of 8 weeks
Placebo sugar pill administered daily for a period of 8 weeks

Participant Flow:   Overall Study
    GR205171   Placebo
STARTED   22   25 
COMPLETED   18   13 
Protocol Violation                2                6 
Withdrawal by Subject                2                5 
Physician Decision                0                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
GR205171 selective neurokinin-1 receptor antagonist
Placebo sugar pill
Total Total of all reporting groups

Baseline Measures
   GR205171   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   25   47 
[Units: Participants]
Count of 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% 
[Units: Years]
Mean (Standard Deviation)
 43.0  (11.5)   38.7  (12.3)   40.9  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      12  54.5%      11  44.0%      23  48.9% 
Male      10  45.5%      14  56.0%      24  51.1% 
Region of Enrollment 
[Units: Participants]
United States   22   25   47 

  Outcome Measures

1.  Primary:   Changes in CAPS Scores.   [ Time Frame: Baseline, 8 weeks ]

2.  Secondary:   Able to Identify Biological Markers That Predict Response to Treatment.   [ Time Frame: 10 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

  More Information

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Sanjay Johan Mathew, Baylor College of Medicine Identifier: NCT00383786     History of Changes
Obsolete Identifiers: NCT00211861
Other Study ID Numbers: 060253
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