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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
Must not have
Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or dementia
Current prescription of venlafaxine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months (hypotheses 2a and 2b)
Awards & highlights

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or dementia.
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I am currently taking venlafaxine.
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I haven't changed my mental health medication in the last 2 months.
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I cannot communicate in English or Spanish.
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I am under 18 years old.
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I have difficulty making decisions due to my health condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PTSD symptoms
PTSD symptoms
Secondary study objectives
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 study objectives
Number of Severe and Moderate Side Effects

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
1,791 Previous Clinical Trials
1,904,806 Total Patients Enrolled
Stanford UniversityOTHER
2,448 Previous Clinical Trials
17,491,694 Total Patients Enrolled
Boston UniversityOTHER
467 Previous Clinical Trials
9,953,568 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
~133 spots leftby Sep 2025
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