Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sanjay Johan Mathew, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00383786
First received: October 3, 2006
Last updated: December 27, 2013
Last verified: December 2013
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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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
  Description
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  
NOT COMPLETED     4     12  
Protocol Violation                 2                 6  
Withdrawal by Subject                 2                 5  
Physician Decision                 0                 1  



  Baseline Characteristics
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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
  Description
GR205171 selective neurokinin-1 receptor antagonist
Placebo sugar pill
Total Total of all reporting groups

Baseline Measures
    GR205171     Placebo     Total  
Number of Participants  
[units: participants]
  22     25     47  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     25     47  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.0  ± 11.5     38.7  ± 12.3     40.9  ± 11.9  
Gender  
[units: participants]
     
Female     12     11     23  
Male     10     14     24  
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.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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
e-mail: sjmathew@bcm.edu


Publications:
Publications automatically indexed to this study:

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
Study First Received: October 3, 2006
Results First Received: September 5, 2013
Last Updated: December 27, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration