NCT02216097

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 8, 2016

Completed
Last Updated

June 29, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

August 12, 2014

Results QC Date

March 10, 2016

Last Update Submit

May 26, 2016

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (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

    Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.

    Baseline, Day 8

Secondary Outcomes (8)

  • Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC)

    Baseline, Day 2

  • Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Right Amygdala

    Baseline, Day 8

  • Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Left Amygdala

    Baseline, Day 8

  • Number of Participants With Abnormal Physical Examination Findings

    Baseline to up to Day 18

  • Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs

    Baseline up to 28 days after last study drug administration (Day 35)

  • +3 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL
Drug: PF-04457845

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04457845DRUG

4mg PF-04457845 tablet taken once daily for 7 days.

Treatment
PlaceboDRUG

Matching placebo tablet taken once daily for 7 days.

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Other psychiatric illness requiring current treatment with medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical and Translational Science Institute (CTSI)

New York, New York, 10016, United States

Location

NYU CTSI Research Pharmacy (Drug Shipment Address)

New York, New York, 10016, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamide

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 13, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 29, 2016

Results First Posted

April 8, 2016

Record last verified: 2016-05

Locations

US(3)