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Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672776
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
J. Douglas Bremner, M.D., Emory University

Brief Summary:
Posttraumatic stress disorder (PTSD) is a major public health problem in this country. It is estimated that at least one out of every seven women in our society have been the victim of childhood sexual abuse at least once before their 18th birthday. Previous studies have shown that stress is associated with damage to neurons of the hippocampus, a brain area involved in learning and memory. Also, imaging studies of brain function are consistent with dysfunction of the medial prefrontal cortex during presentation of traumatic cues. We have previously shown that serotonin reuptake inhibitor medications (paroxetine; Paxil) can change memory function and hippocampal structure in PTSD. We now propose to perform a placebo controlled study with Paxil CR (paroxetine hydrochloride controlled-release tablets), which is thought as paroxetine with less side-effects. The main purpose of this study is to determine the effects of Paxil CR on memory deficits measured with neuropsychological testing, hippocampal volume measured with a magnetic resonance imaging (MRI), medial prefrontal lobe cortical function estimated with PET, and cortisol response (reflecting the intensity of stress) in men and women with PTSD. We plan to recruit 40 subjects. After completing physical examination and evaluating neuropsychiatric history, patients will undergo an initial group of tests which includes memory testing, MRI and PET brain scan, and measurement of cortisol in their saliva. Afterwards, half will receive Paxil CR 12.5 to 62.5 mg and half will receive a placebo (sugar pill) in the beginning of the first 12 weeks as "Double Blind Phase". After 12 weeks, they will be administered memory tests, PET and MRI scan for the post-treatment phase. After this period, Paxil CR will be offered to the placebo group and followed for an additional 12 weeks. They will have final memory tests, and a MRI scan. We hypothesize that Paxil CR exerts its efficacy by acting on abnormal neural circuits, including hippocampus and prefrontal cortex, in PTSD.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder (PTSD) Drug: paroxetine Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Paxil CR on Neural Circuits in PTSD
Study Start Date : May 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Arm Intervention/treatment
Experimental: 1
Drug: paroxetine
Placebo Comparator: 2
Drug: placebo

Primary Outcome Measures :
  1. Brain Function with Traumatic Reminders [ Time Frame: three months ]
    PET measurement of brain activation before and after paroxetine or placebo treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female patients meeting Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for PTSD assessed by the Structured Clinical Interview for DSM IV (SCID).
  • All patients with PTSD will be greater than 18 years of age, and will be required to give informed consent.
  • Patients will be recruited from newspaper advertisements and fliers.
  • All patients must be free of major medical illness on the basis of history and physical examination, lab testing, and electrocardiogram, and must not be actively abusing substances or alcohol.
  • Patients should be free of psychotropic medications for four weeks before the study.

Exclusion Criteria:

  • Pregnant and breast-feeding women will not be studied. Female subjects will be required to have a negative pregnancy test before the study. Female subjects of childbearing age will be advised to use barrier contraception for the duration of the study, in addition to other forms of contraception that they may be using.
  • Serious medical or neurological illness or a hypersensitivity to paroxetine.
  • Past or present steroid use.
  • Electroconvulsive therapy (ECT) within the 6 months prior to study entry.
  • Organic mental disorders or epilepsy
  • History of head trauma
  • Cerebral infectious disease or dyslexia.
  • History of psychosis, schizophrenia, or eating disorders.
  • Active suicidality or homicidality
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Responsible Party: J. Douglas Bremner, M.D., Principal Investigator, Emory University Identifier: NCT00672776    
Other Study ID Numbers: IRB00024970
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by J. Douglas Bremner, M.D., Emory University:
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors