Status:
COMPLETED
Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
PTSD
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 post...
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 soci...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects may be included in the study only if they meet all of the following criteria:
- Male or female subjects, 18 to 65 years.
- Female subjects of childbearing potential must be using a medically accepted means of contraception.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- A negative urine toxicology.
- Subjects must fulfill the criteria for PTSD as defined in DSM-IV (309.81), which should be the primary diagnosis. Diagnoses are based on clinical assessment and confirmed by structured diagnostic interview SCID-P.
- Duration of illness of PTSD for at least 3 months.
- Subjects must have an initial score at Visit 1 and Visit 2 of at least 50 on the CAPS for PTSD Studies.
- Subjects must not have a decrease in the total score of CAPS of greater than 25% during washout (between Visits 1 and 2).
- EXCLUSION CRITERIA:
- Subjects will be excluded from the study for any of the following reasons:
- Presence of psychotic features.
- Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry (Visit 1).
- Female subjects who are either pregnant or nursing.
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
- Previous treatment with NK1 receptor antagonist.
- DSM-IV substance abuse or dependence within the past 90 days.
- Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to Visit 2.
- Treatment with a reversible MAOI, guanethidine, or guanadrel within 1 week or with fluoxetine within 6 weeks prior to Visit 2.
- Treatment with any other concomitant medication with primarily CNS activity.
- Treatment with clozapine or ECT within 12 weeks prior to Visit 2.
- Current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder, other Axis I disorder (except for major depressive disorder, dysthymia and other anxiety disorders that followed exposure to the trauma) as defined in the DSM-IV.
- Patients who are currently at high risk for homicide or suicide, a score greater than 4 on item 10 of the MADRS.
- Current or planned litigation regarding the traumatic event.
- Patients will not be allowed to receive structured psychotherapy during the trial.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00383786
Start Date
September 1 2006
End Date
June 1 2009
Last Update
July 31 2019
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
Mt. Sinai Medical Center
New York, New York, United States, 10029-0574