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

Post-Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02216097
• Other study ID #: B0541013
• Status: Terminated
• Phase: Phase 2
• First received: August 12, 2014
• Last updated: November 12, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• PF-04457845
4mg PF-04457845 tablet taken once daily for 7 days.
• Placebo
Matching placebo tablet taken once daily for 7 days.

Locations

Country	Name	City	State
United States	Clinical and Translational Science Institute (CTSI)	New York	New York
United States	NYU CTSI Research Pharmacy (Drug Shipment Address)	New York	New York
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Blood-oxygen-level dependent Functional Magnetic Resonance Imaging percent signal change in fearful versus neutral face contrast during Emotional Face Processing Task in bilateral amygdala in PF-04457845 versus placebo treated		Day 8	No
Primary	subjects		Day 8	No
Secondary	Difference in Blood-oxygen-level dependent Functional Magnetic Resonance Imaging percent activation in the bilateral vmPFC during the fear extinction recall phase of the Fear Extinction Paradigm in PF-04457845 versus placebo treated subjects.		Day 2	No
Secondary	Change from baseline Blood-oxygen-level dependent Functional Magnetic Resonance Imaging percent signal change in the right amygdala in fear versus neutral faces during face processing task on Day 8 in PF-04457845 versus placebo treated subjects.		Day 8	No
Secondary	Change from baseline Blood-oxygen-level dependent Functional Magnetic Resonance Imaging percent signal change in the left amygdala in fearful versus neutral faces during face processing task on Day 8 in PF-04457845 versus placebo treated subjects.		Day 8	No

External Links

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