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Trial record 89 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

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

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ClinicalTrials.gov Identifier: NCT01490697
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Roger K. Pitman, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Post-traumatic Stress Disorder
Interventions Drug: Mifepristone
Drug: d-Cycloserine
Drug: Placebo-matching Mifepristone
Drug: Placebo-matching d-Cycloserine (DCS)
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Plus Placebo Mifepristone Plus d-Cycloserine (DCS)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 16 18
Completed 15 16
Not Completed 1 2
Reason Not Completed
Did Not Meet PTSD Diagnostic Criteria             1             2
Arm/Group Title Placebo Plus Placebo Mifepristone Plus d-Cycloserine (DCS) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
All randomized participants included in the analysis. 3 participants did not meet PTSD diagnostic criteria and are excluded.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
35.1  (11.8) 41.9  (13.9) 38.5  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
8
  53.3%
9
  56.3%
17
  54.8%
Male
7
  46.7%
7
  43.8%
14
  45.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 16 participants 31 participants
15
 100.0%
16
 100.0%
31
 100.0%
1.Primary Outcome
Title Physiological Posttraumatic Stress Disorder (PTSD) Probability as Determined From Psychophysiologic Responses to Traumatic Recollection
Hide Description 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.
Time Frame 1 week following treatment (Day 14)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.
Arm/Group Title Placebo Plus Placebo Mifepristone Plus d-Cycloserine (DCS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: percent probability
44  (24) 45  (22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Placebo, Mifepristone Plus d-Cycloserine (DCS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-18 to 16
Estimation Comments Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)
2.Secondary Outcome
Title Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score
Hide Description 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.
Time Frame Day 7 (Baseline) and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.
Arm/Group Title Placebo Plus Placebo Mifepristone Plus d-Cycloserine (DCS)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 55.3  (21.9) 52.4  (15.3)
Change from Baseline at Day 14 -5.0  (16.6) -8.9  (11.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Placebo, Mifepristone Plus d-Cycloserine (DCS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
-6.9 to 14.7
Estimation Comments Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)
Time Frame 14 Days
Adverse Event Reporting Description All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.
 
Arm/Group Title Placebo Plus Placebo Mifepristone Plus d-Cycloserine (DCS)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Placebo Plus Placebo Mifepristone Plus d-Cycloserine (DCS)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Plus Placebo Mifepristone Plus d-Cycloserine (DCS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Plus Placebo Mifepristone Plus d-Cycloserine (DCS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Roger K. Pitman, MD
Organization: Massachusetts General Hospital
Phone: 617-726-5333
Responsible Party: Roger K. Pitman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01490697     History of Changes
Other Study ID Numbers: 2009P000647
First Submitted: December 9, 2011
First Posted: December 13, 2011
Results First Submitted: April 6, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017