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Selective Serotonin Reuptake Inhibitor (SSRI)
Prolonged Exposure Therapy + Medication for PTSD
Phase 4
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
military veteran
You have been diagnosed with Posttraumatic Stress Disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks to 40 weeks
Awards & highlights
Study Summary
This trial will compare the effectiveness of different treatments for PTSD, including therapy and medication. The goal is to develop algorithms to predict the best treatment for individual patients.
Who is the study for?
This trial is for military veterans who have been diagnosed with PTSD, can give informed consent, and speak English. They must be willing to undergo Prolonged Exposure therapy or take medications like paroxetine or venlafaxine XR, or both. Veterans who've had a failed trial of these therapies, active psychosis, certain medical conditions that conflict with the treatments, recent suicidal behavior, or history of manic episodes cannot participate.Check my eligibility
What is being tested?
The study compares the effectiveness of Prolonged Exposure (PE) therapy and pharmacotherapy using paroxetine or venlafaxine XR against their combination in treating PTSD. Participants will receive up to 14 sessions of PE and/or medication management over several weeks with follow-up assessments to measure treatment impact on PTSD severity and quality of life.See study design
What are the potential side effects?
Possible side effects from PE may include temporary increases in distress during exposure tasks. Paroxetine can cause dizziness, sleep disturbances, sexual dysfunction among others; venlafaxine XR might lead to nausea, dry mouth, appetite changes etc. Both drugs could potentially increase suicidal thoughts especially at the start.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have served in the military.
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I have been diagnosed with PTSD.
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I am willing to participate in talk therapy, medications, or both.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks to 40 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks to 40 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change during active treatment on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Change during active treatment on the PTSD Checklist for DSM-5 (PCL-5)
Change during follow-up on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
+1 moreSecondary outcome measures
Change during active treatment on the Patient Health Questionnaire depression module (PHQ-9)
Change during active treatment on the Quick Inventory of Depressive Symptoms - clinician rated (QIDS-C)
Therapeutic procedure
+5 moreTrial Design
3Treatment groups
Active Control
Group I: Prolonged Exposure TherapyActive Control1 Intervention
8-14 sessions of psychotherapy, each lasting 60-90 minutes, focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders
Group II: PharmacotherapyActive Control1 Intervention
20-60mg of paroxetine daily, or 75-300mg of venlafaxine XR daily
Group III: Combined treatment (Prolonged Exposure and Pharmacotherapy)Active Control2 Interventions
8-14 sessions of psychotherapy, each lasting 60-90 minutes, focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders AND 20-60mg of paroxetine daily, or 75-300mg of venlafaxine XR daily
Find a Location
Who is running the clinical trial?
San Diego Veterans Healthcare SystemFED
34 Previous Clinical Trials
3,456 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
88 Previous Clinical Trials
56,453 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,016 Previous Clinical Trials
42,873,646 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had episodes of mania in the past.I am not on any treatments that clash with paroxetine or venlafaxine.I have tried Prolonged Exposure therapy or medications like paroxetine and venlafaxine XR without success.I have been diagnosed with PTSD.I am able to understand and agree to the study's procedures and risks.You have served in the military.I am open to trying exercise, medication, or both for my condition.You have served in the military.I am able to understand and agree to the study's procedures and risks.I have been diagnosed with PTSD.I am willing to participate in talk therapy, medications, or both.You currently have severe mental health issues that affect your ability to participate in the study.I have been diagnosed with PTSD.I am willing to undergo physical exercise, medication treatment, or both.I have not had thoughts or plans of suicide in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Prolonged Exposure Therapy
- Group 2: Pharmacotherapy
- Group 3: Combined treatment (Prolonged Exposure and Pharmacotherapy)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04961190 — Phase 4
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