Predicting SSRI Efficacy in Veterans With PTSD

NCT04183205 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-05-22

Study results available
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Summary

This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) or depression are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 5.25 years, until at least 94 participants complete the 17 week study.

Conditions

Interventions

DIAGNOSTIC_TEST

LDAEP

This is an ERP task in which participants hear a series of tones ranging from 74dB to 104dB and electrophysiological activity is measured throughout. For each participant average P2 scores are derived for the 74dB tones, 84dB tones, 94dB tones, and 104dB tones. Then, LDAEP is defined as the slope of these average P2 scores.

DRUG

Placebo

placebo pills of the same size, color and taste as the active drug will be administered

DRUG

sertraline

Sertraline is an FDA approved SSRI for treatment of PTSD.

Sponsors & Collaborators

  • Middlebury College

    collaborator UNKNOWN
  • Massachusetts General Hospital

    collaborator OTHER
  • Ralph H. Johnson VA Medical Center

    collaborator FED
  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Suzanne Pineles, PhD · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2025-03-30
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04183205 on ClinicalTrials.gov