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A Study To Assess the Effects Of PF-04457845 On BOLD fMRI In Subjects With Post Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT02216097
Recruitment Status : Terminated (The study stopped based on Pfizer portfolio prioritization and not due to safety and/or efficacy concern or change in benefit:risk assessment of PF-04457845.)
First Posted : August 13, 2014
Results First Posted : April 8, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of the study is to evaluate proof of mechanism of PF-04457845, using a well-established neuroimaging paradigm including behavioral tasks selected to activate neuro-circuitry relevant to Post Traumatic Stress Disorder. It is hypothesized that PF-04457845 will modulate the Blood-oxygen-level dependent Functional Magnetic Resonance Imaging signal from the relevant neuro-circuits in patients with Post Traumatic Stress Disorder.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: PF-04457845 Drug: Placebo Phase 2

Detailed Description:
This is a Phase II, randomized, placebo-controlled, parallel group design study in male and female subjects with moderate-to-severe Post Traumatic Stress Disorder between the ages of 18 and 60 years old. During this study, a dose of 4 mg PF-04457845 will be administered in the morning on Days 1-7. On Each subject will undergo a resting state fMRI (pre and post and day 8), a fearful vs. neutral faces fMRI task and a fear extinction fMRI paradigm. The Emotional Faces Paradigm and resting state tasks will be performed on Day 1 (prior to drug or placebo) and on Day 8. Acquisition of fear conditioning will be performed during the first imaging session on Day 1. After the first imaging session on Day 1, subjects will complete behavioral rating scales and then be dosed. Approximately six hours after dosing subjects will re-enter the scanner and perform the fear extinction paradigm. On Day 2, subjects will perform the fear extinction memory retention task within the scanner. Further physiological monitoring, including skin conductance and heart rate, will take place during the fear extinction paradigm. One safety follow-up visit will occur between Days 11-18.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study To Assess Effects Of Pf 04457845 On Bold Functional Mri In Subjects With Ptsd
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Drug: PF-04457845
4mg PF-04457845 tablet taken once daily for 7 days.

Placebo Comparator: Placebo Drug: Placebo
Matching placebo tablet taken once daily for 7 days.




Primary Outcome Measures :
  1. Change From Baseline Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging fMRI) Percent Signal Change in Fearful Versus Neutral Face Contrast in Bilateral Amygdala [ Time Frame: Baseline, Day 8 ]
    Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.


Secondary Outcome Measures :
  1. Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC) [ Time Frame: Baseline, Day 2 ]
    Difference measured in BOLD fMRI percent activation in the bilateral vmPFC during the fear extinction recall phase of the fear extinction paradigm.

  2. Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Right Amygdala [ Time Frame: Baseline, Day 8 ]
    Difference measured in BOLD fMRI percent signal change in the right amygdala in fear versus neutral faces during the emotional face processing task.

  3. Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Left Amygdala [ Time Frame: Baseline, Day 8 ]
    Difference measured in BOLD fMRI percent signal change in the left amygdala in fearful versus neutral faces during face processing task.

  4. Number of Participants With Abnormal Physical Examination Findings [ Time Frame: Baseline to up to Day 18 ]
    The full physical examination included head, ears, eyes, nose, mouth, skin, heart, and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.

  5. Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs [ Time Frame: Baseline up to 28 days after last study drug administration (Day 35) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration that were absent before treatment or that worsened relative to pretreatment state. AEs included non-serious AEs and SAEs.

  6. Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern [ Time Frame: Baseline up to Day 18 ]
    The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); chemistry (glucose); urinalysis (dipstick) (urine pH, urine glucose, urine protein, urine blood, urine ketones, urine bilirubin, urine nitrite, urine leukocyte esterase); urinalysis microscopy (urine red blood cell, urine white blood cell, urine bacteria). Only parameters with abnormal values were reported.

  7. Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern [ Time Frame: Baseline up to Day 18 ]
    Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg.

  8. Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern [ Time Frame: Baseline up to Day 18 ]
    ECG criteria of potential clinical concern were QTc absolute value >=450 milliseconds (msec) or QTc absolute change >=30 msec.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18-60 years of age with a primary psychiatric diagnosis of Post Traumatic Stress Disorder

Exclusion Criteria:

  • Other psychiatric illness requiring current treatment with medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216097


Locations
United States, New York
Clinical and Translational Science Institute (CTSI)
New York, New York, United States, 10016
NYU CTSI Research Pharmacy (Drug Shipment Address)
New York, New York, United States, 10016
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02216097     History of Changes
Other Study ID Numbers: B0541013
First Posted: August 13, 2014    Key Record Dates
Results First Posted: April 8, 2016
Last Update Posted: June 29, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders