Trial Outcomes & Findings for Developing Memory Reconsolidation Blockers as Novel Posttraumatic Stress Disorder (PTSD) Treatments (NCT NCT01490697)

Results Overview

The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses to script-driven imagery of traumatic events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator electromyogram (EMG) responses of the left lateral frontalis facial muscle in microVolts. Responses for the traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant's posterior probability of being classified as PTSD.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

1 week following treatment (Day 14)

Results posted on

2017-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Plus Placebo Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.	Mifepristone Plus d-Cycloserine (DCS) DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
Overall Study STARTED	16	18
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Plus Placebo Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.	Mifepristone Plus d-Cycloserine (DCS) DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
Overall Study Did Not Meet PTSD Diagnostic Criteria	1	2

Baseline Characteristics

Developing Memory Reconsolidation Blockers as Novel Posttraumatic Stress Disorder (PTSD) Treatments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Plus Placebo n=15 Participants Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.	Mifepristone Plus d-Cycloserine (DCS) n=16 Participants DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.	Total n=31 Participants Total of all reporting groups
Age, Continuous	35.1 years STANDARD_DEVIATION 11.8 • n=5 Participants	41.9 years STANDARD_DEVIATION 13.9 • n=7 Participants	38.5 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week following treatment (Day 14)

Population: All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.

The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses to script-driven imagery of traumatic events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator electromyogram (EMG) responses of the left lateral frontalis facial muscle in microVolts. Responses for the traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant's posterior probability of being classified as PTSD.

Outcome measures

Outcome measures
Measure	Placebo Plus Placebo n=15 Participants Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.	Mifepristone Plus d-Cycloserine (DCS) n=16 Participants DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
Physiological Posttraumatic Stress Disorder (PTSD) Probability as Determined From Psychophysiologic Responses to Traumatic Recollection	44 percent probability Standard Deviation 24	45 percent probability Standard Deviation 22

SECONDARY outcome

Timeframe: Day 7 (Baseline) and Day 14

Population: All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.

IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 14 IES-R total score from the Day 7 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms.

Outcome measures

Outcome measures
Measure	Placebo Plus Placebo n=15 Participants Placebo-matching DCS 100 mg capsule orally followed by placebo-matching mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.	Mifepristone Plus d-Cycloserine (DCS) n=16 Participants DCS 100 mg capsule orally followed by mifepristone1800 mg tablet orally 4 hours later and 90 minutes prior to traumatic memory retrieval via the traumatic event script preparation procedure, all on Day 7.
Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score Baseline	55.3 score on a scale Standard Deviation 21.9	52.4 score on a scale Standard Deviation 15.3
Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score Change from Baseline at Day 14	-5.0 score on a scale Standard Deviation 16.6	-8.9 score on a scale Standard Deviation 11.9

Adverse Events

Placebo Plus Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mifepristone Plus d-Cycloserine (DCS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roger K. Pitman, MD

Massachusetts General Hospital

Phone: 617-726-5333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place