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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months (hypotheses 2a and 2b)

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

0 / 6Eligibility criteria met