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PF-04457845 fMRI study in PTSD

NCT02216097Phase 2

Key facts

Status: Terminated
Start: Oct 2014
Primary completion: Mar 2015
Countries: 1
Sponsor: Pfizer
Modality: Small Molecules

Drugs: JZP-150
Conditions: post-traumatic stress disorder (PTSD)

Overview

Phase 2, randomised, double-blind trial of JZP-150 in post-traumatic stress disorder (PTSD) (2 arms), sponsored by Pfizer. Primary endpoint: 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 at Day 8. Started Oct 2014; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Treatment
PF-04457845 4 mg daily for 7 days
Placebo
Matching placebo daily for 7 days

Who it enrols

Adults 18-60 with moderate-to-severe PTSD, excluding those with other psychiatric illnesses requiring current medication.

Endpoints

Primary

Change From Baseline Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging fMRI) Percent Signal Change in Fearful Versus Neutral Face Contrast in Bilateral AmygdalaDay 8

Secondary

Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC)Day 2
Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Right AmygdalaDay 8
Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Left AmygdalaDay 8
Number of Participants With Abnormal Physical Examination FindingsDay 18
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEsDay 35
Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical ConcernDay 18
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical ConcernDay 18
Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical ConcernDay 18

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