A POC Clinical Trial for a First-in-Class Vasopressin 1a Receptor Antagonist

Clinical Trial Details

We are seeking participants for a clinical trial which will test an experimental drug for the treatment of post-traumatic stress disorder (PTSD). 

Following the initial screening phase, you will receive the medication treatment for 8 weeks and the placebo for 8 weeks. The study will last a total of 18 weeks, and you will be assessed at baseline and then every 2 weeks until the end of the study. You will be compensated for all completed assessments (up to a total of $400). 

Key Eligibility: 

Inclusion Criteria

  • 18-65 years of age
  • Primary PTSD as defined by DSM-V for at least 3 months and a minimum CAPS score of 50
  • Medically stable as confirmed by medical history, physical examination, and screening laboratory results
  • Negative urine drug screen for drugs of abuse
  • Sexually active female subjects must be willing to use a reliable form of birth control (condom, diaphragm, hormonal contraceptive, IUD)

Exclusion Criteria

  • Current or prior congestive heart failure, myocardial infarction or other heart disease, kidney disease, history of hepatitis or other liver disease; HIV; Hepatitis A, B, or C; other clinically unstable medical disease; progressive CNS disorder/disease; moderate or severe traumatic brain injury
  • Pregnancy or currently breast feeding
  • Current or past psychotic disorder, bipolar Type I disorder, or dementia
  • Drug abuse or dependency within past 6 months (other than nicotine and caffeine)
  • Current suicidal or homicidal ideation and those with a history of suicide attempt in the past year
  • Subjects with pending litigation related to a traumatic event
  • Subjects currently receiving a validated PTSD, anxiety or depression-focused psychotherapy (e.g., exposure therapy) or who have completed a course of evidence-based therapy for PTSD, anxiety or depression within the past three months
  • Subjects currently receiving another PTSD treatment (drug therapy or alternative medicine) who began it within the past three months
  • Non-English-speaking subjects

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mariel Emrich
212-746-0783
mae2050@med.cornell.edu

Westchester

Contact(s)

Mariel Emrich
212-746-0783
mae2050@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1506016348

ClinicalTrials.gov:

NCT02733614

Sponsor:

W81XWH-15-1-0645

Status

Open to Enrollment

Age Group

Adult

Sponsor