Trial Outcomes & Findings for Rapamycin as a Means of Interference With Reconsolidation of Posttraumatic Stress Disorder-related Traumatic Memory (NCT NCT01449955)

Results Overview

Clinician administered interview which assesses the symptoms of Posttraumatic Stress disorder at baseline, and then again 1 month posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

Baseline and 1 month posttreatment

Results posted on

2018-07-18

Participant Flow

Recruited by flyers, clinician referral and letters mailed to male VA North Texas patients with PTSD.

excluded if did not meet PTSD criteria according to the CAPS

Participant milestones

Participant milestones
Measure	Rapamycin (e.g., Sirolimus) 15mg Rapamycin administered once in pill form	Placebo 15mg Placebo administered once in pill form
Overall Study STARTED	28	26
Overall Study COMPLETED	27	24
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Rapamycin (e.g., Sirolimus) 15mg Rapamycin administered once in pill form	Placebo 15mg Placebo administered once in pill form
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Rapamycin as a Means of Interference With Reconsolidation of Posttraumatic Stress Disorder-related Traumatic Memory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rapamycin n=28 Participants 15mg Rapamycin administered once in pill form	Placebo n=26 Participants 15mg Placebo administered once in pill form	Total n=54 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	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	42.64 years STANDARD_DEVIATION 14.39 • n=5 Participants	42.15 years STANDARD_DEVIATION 15.46 • n=7 Participants	42.21 years STANDARD_DEVIATION 14.77 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	26 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 month posttreatment

Clinician administered interview which assesses the symptoms of Posttraumatic Stress disorder at baseline, and then again 1 month posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.

Outcome measures

Outcome measures
Measure	Rapamycin (e.g., Sirolimus) n=27 Participants 15mg Rapamycin administered once in pill form	Placebo n=24 Participants 15 mg Placebo administered once in pill form	Rapamycin (e.g., Sirolimus) at 3 Months Posttreatment 15mg Rapamycin administered once in pill form at 3 months Posttreatment	Placebo at 3 Months Posttreatment 15 mg Placebo administered once in pill form at 3 months posttreatment
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) Baseline	72.13 scores on a scale Standard Deviation 15.27	70.63 scores on a scale Standard Deviation 16.37	—	—
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) 1 month posttreatment	58.27 scores on a scale Standard Deviation 22.96	64.54 scores on a scale Standard Deviation 17.88	—	—

PRIMARY outcome

Timeframe: change in CAPS score from baseline to 3 months posttreatment

The CAPS is administered to assess the frequency and intensity of PTSD symptoms at baseline, and then again 3 months posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.

Outcome measures

Outcome measures
Measure	Rapamycin (e.g., Sirolimus) n=27 Participants 15mg Rapamycin administered once in pill form	Placebo n=24 Participants 15 mg Placebo administered once in pill form	Rapamycin (e.g., Sirolimus) at 3 Months Posttreatment n=27 Participants 15mg Rapamycin administered once in pill form at 3 months Posttreatment	Placebo at 3 Months Posttreatment n=24 Participants 15 mg Placebo administered once in pill form at 3 months posttreatment
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)	72.13 units on a scale Standard Deviation 15.27	70.63 units on a scale Standard Deviation 16.37	55.26 units on a scale Standard Deviation 22.62	62.63 units on a scale Standard Deviation 17.60

SECONDARY outcome

Timeframe: change in PCL score from baseline to 1 month posttreatment

Self-report instrument which assesses the intensity of Posttraumatic Stress Disorder symptoms. The PCL measures the 17 DSM-IV PTSD criteria in 17 items. For each item the participant can respond with a rating of 1-5 (with 1 indicating not at all bothered 5 indicating extremely bothered by the symptom) The range of total scores on the PCL is from 17-85, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items.

Outcome measures

Outcome measures
Measure	Rapamycin (e.g., Sirolimus) n=27 Participants 15mg Rapamycin administered once in pill form	Placebo n=24 Participants 15 mg Placebo administered once in pill form	Rapamycin (e.g., Sirolimus) at 3 Months Posttreatment n=27 Participants 15mg Rapamycin administered once in pill form at 3 months Posttreatment	Placebo at 3 Months Posttreatment n=24 Participants 15 mg Placebo administered once in pill form at 3 months posttreatment
PTSD Checklist (PCL)	57.19 units on a scale Standard Deviation 10.61	60.83 units on a scale Standard Deviation 10.26	49.62 units on a scale Standard Deviation 13.14	55.00 units on a scale Standard Deviation 11.85

SECONDARY outcome

Timeframe: change in PCL score from baseline to 3 months posttreatment

Self-report instrument which assesses the intensity of Posttraumatic Stress Disorder symptoms. The PCL measures the 17 DSM-IV PTSD criteria in 17 items. For each item the participant can respond with a rating of 1-5 (with 1 indicating not at all bothered 5 indicating extremely bothered by the symptom) The range of total scores on the PCL is from 17-85, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items.

Outcome measures

Outcome measures
Measure	Rapamycin (e.g., Sirolimus) n=27 Participants 15mg Rapamycin administered once in pill form	Placebo n=24 Participants 15 mg Placebo administered once in pill form	Rapamycin (e.g., Sirolimus) at 3 Months Posttreatment n=27 Participants 15mg Rapamycin administered once in pill form at 3 months Posttreatment	Placebo at 3 Months Posttreatment n=24 Participants 15 mg Placebo administered once in pill form at 3 months posttreatment
PTSD Checklist (PCL)	57.19 units on a scale Standard Deviation 10.61	60.83 units on a scale Standard Deviation 10.26	51.07 units on a scale Standard Deviation 13.81	54.13 units on a scale Standard Deviation 11.23

SECONDARY outcome

Timeframe: change in QIDS score from baseline to 1 month posttreatment

The QIDS is a 16-item self-report measure that assesses how much a participant endorses each of the DSM-IV-TR symptoms of depression, with each item scored from 0 (no endorsement of symptom) to 3 (endorsement of severe symptomatology). Scores on the QIDS range from 0-27, with higher scores indicating higher depressive symptom severity.

Outcome measures

Outcome measures
Measure	Rapamycin (e.g., Sirolimus) n=27 Participants 15mg Rapamycin administered once in pill form	Placebo n=24 Participants 15 mg Placebo administered once in pill form	Rapamycin (e.g., Sirolimus) at 3 Months Posttreatment n=27 Participants 15mg Rapamycin administered once in pill form at 3 months Posttreatment	Placebo at 3 Months Posttreatment n=24 Participants 15 mg Placebo administered once in pill form at 3 months posttreatment
Quick Inventory of Depressive Symptomatology (QIDS)	14.48 units on a scale Standard Deviation 3.97	13.79 units on a scale Standard Deviation 4.45	11.27 units on a scale Standard Deviation 5.03	11.75 units on a scale Standard Deviation 3.75

SECONDARY outcome

Timeframe: change in QIDS score from baseline to 3 months posttreatment

The QIDS is a 16-item self-report measure that assesses how much a participant endorses each of the DSM-IV-TR symptoms of depression, with each item scored from 0 (no endorsement of symptom) to 3 (endorsement of severe symptomatology). Scores on the QIDS range from 0-27, with higher scores indicating higher depressive symptom severity.

Outcome measures

Outcome measures
Measure	Rapamycin (e.g., Sirolimus) n=27 Participants 15mg Rapamycin administered once in pill form	Placebo n=24 Participants 15 mg Placebo administered once in pill form	Rapamycin (e.g., Sirolimus) at 3 Months Posttreatment n=27 Participants 15mg Rapamycin administered once in pill form at 3 months Posttreatment	Placebo at 3 Months Posttreatment n=24 Participants 15 mg Placebo administered once in pill form at 3 months posttreatment
Quick Inventory of Depressive Symptomatology (QIDS)	14.48 units on a scale Standard Deviation 3.97	13.79 units on a scale Standard Deviation 4.45	11.56 units on a scale Standard Deviation 5.13	11.29 units on a scale Standard Deviation 4.32

Adverse Events

Rapamycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Alina Suris

UT Southwestern/VA North Texas

Phone: 214-857-0334

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place