N/A
N=54
Rapamycin as a Means of Interference With Reconsolidation of Posttraumatic Stress Disorder-related Traumatic Memory
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01449955 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) — 72.13; 70.63; 58.27; 64.54 scores on a scale — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rapamycin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) |
72.13; 70.63; 55.26; 62.63 | > 0.5 |
| PRIMARY Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) |
72.13; 70.63; 55.26; 62.63 | > 0.5 |
| SECONDARY PTSD Checklist (PCL) |
57.19; 60.83; 51.07; 54.13 | > .05 |
| SECONDARY PTSD Checklist (PCL) |
57.19; 60.83; 51.07; 54.13 | > .05 |
| SECONDARY Quick Inventory of Depressive Symptomatology (QIDS) |
14.48; 13.79; 11.56; 11.29 | > .05 |
| SECONDARY Quick Inventory of Depressive Symptomatology (QIDS) |
14.48; 13.79; 11.56; 11.29 | > .05 |
Summary
The purpose of the proposed study is to determine if pairing reactivation of a traumatic memory with a single administration of Rapamycin (e.g., Sirolimus) in men with combat-related Posttraumatic Stress Disorder leads to a reduction of the emotional strength of that particular traumatic memory.
The following hypotheses will be tested:
1. Traumatic memory reactivation paired with a single dose of Rapamycin will decrease objective measures of stress and self-report of stress during replay of the traumatic memory, relative to, subjects receiving placebo.
2. Pairing administration of Rapamycin with traumatic memory reactivation will decrease symptoms of Posttraumatic Stress Disorder one month and three months later, relative to patients receiving placebo.
Eligibility Criteria
Inclusion Criteria
- Male Veterans
- Diagnosis of Posttraumatic Stress Disorder related to combat
Exclusion Criteria
- Hypersensitivity to Rapamycin
- Organic brain damage (including unresolved Traumatic Brain Injury sequela)
- Substance dependence in the last three months
- On any immunosuppressant therapy
- Prominent suicidal or homicidal features
- Medical conditions: systemic infections, congestive heart failure, renal failure, hepatic failure
Data sourced from ClinicalTrials.gov (NCT01449955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.