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Trial record 2 of 6 for:    PTSD and CRF

Analyzing Female Trauma Exposed Responses to a Medication (AFTER)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01814332
First received: March 11, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This purpose of this study is to look at the safety of the experimental drug GSK561679 as well as its effects on PTSD symptoms, thinking and memory, startle reaction, stress hormones, and mental health symptoms in comparison to placebo (an inactive substance).


Condition Intervention Phase
Stress Disorders, Post-traumatic
Drug: GSK561679
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CRF Receptor Antagonist for PTSD and Related Sleep Disturbances in Women

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • CAPS score after 6 weeks of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK561679
GSK561679, oral administration, 350mg/day, 6 week administration
Drug: GSK561679
GSK561679, oral administration, 350mg/day, 6 week administration
Other Name: CRF1 antagonist
Placebo Comparator: Placebo
Placebo compound treatment for comparison with IP
Drug: Placebo
Placebo compound treatment for comparison with IP
Other Name: Sugar pill

Detailed Description:

A growing body of literature suggests that stress-related disorders such as PTSD are associated with chronically increased activity of CNS circuits that utilize corticotropin-releasing factor (CRF), a neuropeptide involved in mediating the neuroendocrine, immune, autonomic, and behavioral responses to stress. CRF1 receptor antagonists exert significant dampening effects on this system, but have never been investigated in patients with PTSD. The investigators at Mount Sinai School of Medicine (MSSM) and the National Institute of Mental Health (NIMH) Intramural Research Program have conducted a Phase II proof-of-concept clinical trial of a neurokinin-1 antagonist provided by GlaxoSmithKline (GSK). In this investigation, we will conduct a 2-site (Emory and MSSM), 6-week, randomized, double-blind, placebo-controlled, parallel-arm, fixed dose trial evaluating the efficacy, safety, and tolerability of GSK561679 for 154 female adult outpatients with PTSD. The San Francisco Department of Veterans Affairs Medical Center (SFVAMC) was added as a site in July 2012. SFVAMC will enroll 40 female adult outpatients with PTSD.

We propose to investigate the efficacy of the highly specific CRF1 antagonist GSK561679 in PTSD in a placebo-controlled clinical trial. GSK561679 has not been approved by the Food and Drug Administration for the treatment of any condition. Furthermore, we propose to longitudinally investigate whether certain biological surrogate markers (neuroendocrine, neurophysiology, genotyping) are predictive of treatment response. If a patient is already taking medication for PTSD and has achieved therapeutic response, she will not be tapered off effective medication(s) to participate in this study, and will not be eligible for the study. Taper and discontinuation of medications in preparation for this study will only occur in those patients who are not responding to medication treatment for PTSD.

Preclinical and clinical literature also exists which implicates both hypothalamic and extra hypothalamic CRF in stress-related insomnia and the regulation of non-rapid eye movement delta sleep. There is preliminary evidence that blocking CRF signaling results in an immediate improvement in stress-related sleep disturbances. Disturbed sleep is the most prevalent symptom endorsed by PTSD patients. It is potentially debilitating in many domains of functioning, and it is an outcome that can be objectively and precisely measured with sleep EEG. Therefore, an exploratory aim of this study will be to investigate the impact of GSK561679 on objective measures of sleep continuity and quantitative sleep EEG using ambulatory polysomnography. All subjects enrolled at SFVAMC who meet inclusion and exclusion criteria for the study will be given the option of having their sleep monitored throughout the study

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female between 18-65 years of age
  • Able to provide consent and willing to participate in research
  • PTSD duration of illness at least 3 months
  • Negative Urine toxicology test
  • Agrees to use protocol-defined effective birth control method

Exclusion Criteria:

  • Subject is currently participating in another clinical trial in which she is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to PTSD, or 1 month for studies related to PTSD
  • Subject has a documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis
  • Subject requires ongoing treatment with medications that are prohibited per protocol
  • Subject has a stool positive for occult blood.
  • Pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814332

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas C. Neylan, MD San Francisco VA Medical Center, San Francisco, CA
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01814332     History of Changes
Other Study ID Numbers: 09S-NIMH-002
Study First Received: March 11, 2013
Last Updated: July 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stress disorders, Post-traumatic
Sleep

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014