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Selective Serotonin Reuptake Inhibitor

Antidepressants + Therapy for PTSD (STEPS Trial)

Phase 4
Waitlist Available
Research Sponsored by University of Washington
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 8 months (hypotheses 2a and 2b)
Awards & highlights

STEPS Trial Summary

This trial will study whether commonly prescribed antidepressants or brief exposure-based therapies are effective treatments for PTSD that are feasible to deliver in primary care.

Who is the study for?
This trial is for adults with PTSD who have experienced trauma, as indicated by specific screening tests. It's not for those under 18, recently changed psychotropic meds, prefer specialty mental health care, prisoners, non-English/Spanish speakers, terminally ill or decision-impaired individuals. Also excluded are those on venlafaxine or diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder or dementia.Check my eligibility
What is being tested?
The study compares initial treatments of PTSD in primary care settings: antidepressants versus brief psychotherapy. For non-responders to the first treatment choice, it will test different follow-up strategies (switching or augmenting). The goal is to determine which sequence of treatments works best.See study design
What are the potential side effects?
Possible side effects may include typical reactions to antidepressants like nausea, headaches and sleep disturbances; and emotional discomfort related to exposure therapy such as temporary increases in distress recalling traumatic events.

STEPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months (hypotheses 2a and 2b)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months (hypotheses 2a and 2b) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in PTSD symptoms
PTSD symptoms
Secondary outcome measures
Change in Depression Symptoms
Change in Generalized Anxiety Symptoms
Change in Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score
Other outcome measures
Number of Severe and Moderate Side Effects

STEPS Trial Design

3Treatment groups
Active Control
Group I: SSRI Then Augmentation by WETActive Control2 Interventions
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.
Group II: SSRI Then Switch to SNRIActive Control2 Interventions
Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.
Group III: WET Then Switch to SSRIActive Control2 Interventions
Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,843,651 Total Patients Enrolled
Stanford UniversityOTHER
2,386 Previous Clinical Trials
17,333,308 Total Patients Enrolled
Boston UniversityOTHER
454 Previous Clinical Trials
9,940,870 Total Patients Enrolled

Media Library

Selective serotonin reuptake inhibitor (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04597190 — Phase 4
Post-Traumatic Stress Disorder Research Study Groups: SSRI Then Augmentation by WET, SSRI Then Switch to SNRI, WET Then Switch to SSRI
Post-Traumatic Stress Disorder Clinical Trial 2023: Selective serotonin reuptake inhibitor Highlights & Side Effects. Trial Name: NCT04597190 — Phase 4
Selective serotonin reuptake inhibitor (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04597190 — Phase 4
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04597190 — Phase 4

Frequently Asked Questions

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

Are there precedents for augmenting SSRI treatments with WET?

"At the moment, 27 clinical trials are being conducted in order to investigate SSRI Then Augmentation by WET. Three of these studies have reached Phase 3. In total, 45 sites situated in Cape Town and New york are running experiments for this therapy."

Answered by AI

Are there vacancies left in this clinical trial for potential participants?

"Affirmative. According to the information posted on clinicaltrials.gov, this experiment is currently seeking participants and was initially published on April 1st 2021. The trial needs 700 volunteers from 16 different medical centres for its completion."

Answered by AI

How many participants are being monitored as part of this clinical experiment?

"This clinical trial requires 700 qualified participants to take part, which can be completed at Partnership Health Center in Montana and San Diego VA Medical Center in California. In order for an individual to qualify they must meet the designated inclusion criteria."

Answered by AI

Is the pharmacological combination of SSRI and WET a safe option for individuals?

"Our evaluation of the safety level associated with SSRI Then Augmentation by WET was a 3, given that this treatment is approved and has been tested in Phase 4 clinical trials."

Answered by AI

In what locations is the management of this research project taking place?

"This research endeavor is currently running at 16 sites across the USA, including but not limited to Missoula, San Diego and Franklin. Prospective participants should consider selecting the site closest to them in order to minimize any travel-related burdens."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Oklahoma
Other
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Little Rock VA Medical Center
San Diego VA Medical Center
VA Eastern Colorado Health Care
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
2

What questions have other patients asked about this trial?

Is there a BMI limit?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I don’t like being depressed. Living with PTSD is hard,very hard. I am interested in new ways to treat my PTSD and help further study on PTSD.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Sequenced Treatment Effectiveness for Posttraumatic Stress
John Cooper Fortney 2021. "Sequenced Treatment Effectiveness for Posttraumatic Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04597190.
~175 spots leftby Apr 2025
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