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ERG, all participants for Post-Traumatic Stress Disorder (BRIGHT Trial)

N/A

Recruiting

Led By Rebecca Hendrickson, MD, PhD

Research Sponsored by VA Puget Sound Health Care System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ptsd measures will be collected as a part of the baseline assessment. pcl-5 will also be repeated at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.

Awards & highlights

BRIGHT Trial Summary

This trial aims to investigate if the electroretinogram (ERG) can be used as a biomarker to understand how selective serotonin reuptake inhibitors (SSRIs) like sertral

Who is the study for?

This trial is for veterans with PTSD. Participants will have their eye's electrical activity (ERG) measured before and after taking sertraline, an approved medication for PTSD. They must be willing to share their PTSD symptoms and treatment history.Check my eligibility

What is being tested?

The study is testing if the ERG, which measures retina signals, can predict how well veterans with PTSD respond to sertraline. It checks changes in the ERG waveform before and after a single dose of the medication.See study design

What are the potential side effects?

While this study focuses on measuring ERG waveforms rather than side effects, sertraline may cause nausea, sleep issues, tremors, sexual dysfunction or mood swings as common side effects.

BRIGHT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ptsd measures will be collected as a part of the baseline assessment. pcl-5 will also be repeated at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ptsd measures will be collected as a part of the baseline assessment. pcl-5 will also be repeated at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.

This trial's timeline: 3 weeks for screening, Varies for treatment, and ptsd measures will be collected as a part of the baseline assessment. pcl-5 will also be repeated at the follow up visit for a subset of participants who qualify, up to 1 year following baseline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ERG b-wave amplitude response to SSRI

Secondary outcome measures

Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score

Total PTSD Checklist for DSM-5 (PCL-5)

BRIGHT Trial Design

1Treatment groups

Experimental Treatment

Group I: ERG, all participantsExperimental Treatment1 Intervention

All participants undergo ERG recording before and after a single dose of sertraline 50 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RETeval

2013

N/A

~470

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Puget Sound Health Care SystemLead Sponsor

65 Previous Clinical Trials

227,763 Total Patients Enrolled

Rebecca Hendrickson, MD, PhDPrincipal InvestigatorVA Puget Sound Health Care System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve individuals who have reached the age of 18 or older?

"To be considered for inclusion in this research, applicants must fall between 21 and 75 years of age."

Answered by AI

What is the upper limit for patient enrollment in this medical study?

"Affirmative. Information from clinicaltrials.gov indicates that this ongoing medical study is actively inviting participants. Originally posted on February 12, 2024, and most recently revised on April 10, 2024, the trial aims to enroll about 50 individuals at a single designated site."

Answered by AI

Which individuals are considered more suitable candidates for participation in this medical study?

"Individuals aged between 21 and 75 years old diagnosed with post-traumatic stress disorder are eligible to participate in this study, which aims to enroll a maximum of 50 participants."

Answered by AI

Is this medical research study currently open for enrollment?

"Yes, the information available on clinicaltrials.gov indicates that this investigation is actively seeking volunteers. Initially uploaded on February 12th, 2024, with the latest update done on April 10th, 2024. The trial aims to enroll fifty participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biomarkers in the Retina for Prognosticating Mental Health Treatments

2024. "Biomarkers in the Retina for Prognosticating Mental Health Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06363968.

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