Trial Outcomes & Findings for Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder (NCT NCT00383786)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Baseline, 8 weeks

Results posted on

2019-07-31

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	22	25
Overall Study COMPLETED	18	13
Overall Study NOT COMPLETED	4	12

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Protocol Violation	2	6
Overall Study Withdrawal by Subject	2	5
Overall Study Physician Decision	0	1

Baseline Characteristics

Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GR205171 n=22 Participants selective neurokinin-1 receptor antagonist	Placebo n=25 Participants sugar pill	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.0 years STANDARD_DEVIATION 11.5 • n=5 Participants	38.7 years STANDARD_DEVIATION 12.3 • n=7 Participants	40.9 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	25 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GR205171 n=20 Participants	Placebo n=19 Participants
Changes in CAPS Scores.	43.5 scores on a scale Standard Deviation 5.1	51.1 scores on a scale Standard Deviation 5.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

Adverse Events

GR205171

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GR205171 n=22 participants at risk selective neurokinin-1 receptor antagonist	Placebo n=25 participants at risk sugar pill
Nervous system disorders Headache	59.1% 13/22	24.0% 6/25

Additional Information

Sanjay Mathew, MD/PI

Baylor College of Medicine

Phone: 7137985439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place