Mode
Text Size
Log in / Sign up
N/A N=54 Randomized Double-blind Treatment

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

Posttraumatic Stress Disorder

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search