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Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans (NOSSTIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anne Germain, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01637584
First received: June 15, 2012
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

The overarching objectives of this study are: 1) To investigate the neurobiology of posttraumatic stress disorder (PTSD) during REM and NREM sleep relative to wakefulness; 2) To identify the neurobiological underpinnings of sleep treatment response to prazosin or placebo during wakefulness, REM sleep, and NREM sleep in OIF/OEF veterans with PTSD; and 3) To explore pre-treatment brain activity patterns during wakefulness, REM sleep, and NREM sleep that predict sleep treatment response. We will also explore the stability of the PET signal by comparing pre- and post-placebo changes in brain glucose metabolism in non-responders. For non-PTSD veterans, the stability of the PET signal will be evaluated in a subsample of 6 veterans without PTSD who will repeat the PET imaging procedures 8 weeks after the initial PET series.

The overarching hypothesis is that PTSD is characterized by neurobiological alterations in the amygdala, mPFC, and brain centers involved in the regulation of NREM and REM sleep, and that these neurobiological changes are normalized with effective sleep treatment.


Condition Intervention
Non PTSD
PTSD
 Drug: Prazosin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Neuroimaging data from Positron Emission Tomography [ Time Frame: Pre intervention and 8-10 weeks later ] [ Designated as safety issue: No ]
    Conducted prior to intervention and following intervention as a means of reporting change.


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prazosin
Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.
 Drug: Prazosin
The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.
Placebo Comparator: Placebo
A placebo is a sugar pill, which will be used to compare with the results of the active medication
 Drug: Placebo
The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.

Detailed Description:

PTSD affects both daytime functioning and sleep. Complaints of poor sleep, objective disruption of sleep, and heightened sympathovagal tone during sleep occurring early after trauma exposure increase the risk of developing PTSD up to one year later. (1-4). Insomnia is one the most common reasons for referral to mental health services in active duty personnel (5). In military personnel returning from Iraq and Afghanistan, more than 70 percent of those with PTSD report sleep problems and fatigue, whereas more than 25% percent of those without PTSD endorse these symptoms (6). Other disruptive nocturnal behaviors and sleep disorders including sleep terrors, nocturnal anxiety attacks, simple and complex motor behaviors and vocalizations, acting out dreams, sleep apnea, and periodic leg movement disorders are also frequently reported by PTSD patients (7-12). In PTSD, sleep disturbances independently contribute to poor clinical outcomes such as increased severity of daytime PTSD symptoms (8), depression (13), suicidality (13), general psychiatric distress (14), poorer quality of life and functioning (14), poorer perceived physical health (14), and increased substance use (15;16).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • OIF/OEF veteran
  • Between the ages of 18 and 50 years old
  • Not taking medications known to affect sleep or wake function for 2 weeks

Additional selection criteria for PTSD subjects are:

  • Trauma occurred three months or more before study entry
  • Meeting diagnostic criteria for current PTSD according to the CAPS
  • Participants will remain in ongoing counseling services

Additional selection criterion for non-PTSD healthy subjects:

  • Not meet DSM-IV diagnostic criteria for current PTSD
  • Have a total score < 13 on the Beck Depression Inventory
  • Participants who are active-duty military personnel will be required to obtain permission from their commander to participate in this study.

Exclusion Criteria:

  • Current diagnosis of untreated, severe depression as determined by the Structured Clinical Interview for DSM-IV, non-patient version
  • Beck Depression Inventory > 30
  • History of psychotic or bipolar disorder
  • Current history (within 3 months) of substance or alcohol abuse
  • Significant or unstable acute or chronic medical conditions
  • Other current sleep disorders
  • Presence of implanted devices or metal in body such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
  • Fear of closed spaces
  • Previous radiation exposure (past year) that exceeds recommended safety limits
  • Pregnancy or breast feeding
  • Resting blood pressure < 90/60 at the screening physical examination
  • Heart rate > 100 beats/minutes
  • Current use of a beta-blocker
  • Use of an alpha-1 antagonist agent in the previous 3 weeks
  • Refusal to follow the safety measures in the case of use of a phosphodiesterase 5 inhibitor (Cialis, Viagra, Levitra)
  • Unexpected, untreated, or serious EKG findings
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637584

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: Anne Germain, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01637584     History of Changes
Other Study ID Numbers: PRO08050307
Study First Received: June 15, 2012
Last Updated: July 13, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Prazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
 Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013