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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 below
Select...
You have served in the military.
Select...
I have been diagnosed with PTSD.
Select...
I am willing to participate in talk therapy, medications, or both.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks to 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks to 40 weeks 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 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 more
Secondary 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 more

Trial 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
87 Previous Clinical Trials
56,413 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,881,759 Total Patients Enrolled

Media Library

Paroxetine (Selective Serotonin Reuptake Inhibitor (SSRI)) Clinical Trial Eligibility Overview. Trial Name: NCT04961190 — Phase 4
Post-Traumatic Stress Disorder Research Study Groups: Prolonged Exposure Therapy, Pharmacotherapy, Combined treatment (Prolonged Exposure and Pharmacotherapy)
Post-Traumatic Stress Disorder Clinical Trial 2023: Paroxetine Highlights & Side Effects. Trial Name: NCT04961190 — Phase 4
Paroxetine (Selective Serotonin Reuptake Inhibitor (SSRI)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04961190 — Phase 4
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04961190 — Phase 4

Frequently Asked Questions

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

What is the present enrollment size for this trial?

"Affirmative. The available information hosted on clinicaltrials.gov confirms that this medical study, which was initially posted on May 25th 2022, is actively seeking participants. 450 individuals are needed to enrol from 6 distinct health-care sites."

Answered by AI

What mental health issues are usually addressed with Prolonged Exposure Therapy?

"Prolonged Exposure Therapy is a recommended treatment for menopausal symptoms, phobias, social anxieties and Post Traumatic Stress Disorder (PTSD)."

Answered by AI

Are participants in this experiment required to be at least 18 years old?

"This medical trial has an age cap of 75 and a floor of 18 years old. Further, there are 45 studies for those aged younger than eighteen and 337 for seniors over 65."

Answered by AI

Is there capacity for additional participants in this research?

"Affirmative. Clinicaltrials.gov data confirms that recruitment for this medical trial is still underway; it was initially published on May 25th 2022 and last updated on October 31st 2022, seeking 450 participants across 6 different sites."

Answered by AI

Are various hospitals in this city conducting the research?

"Investigating this medical trial are the VA San Diego Healthcare System, Milwaukee VA Medical Center and Coatesville VA Medicial Centre. Additionally, another 6 clinical sites across the country will be participating as well."

Answered by AI

What outcomes is this experiment trying to realize?

"This medical trial seeks to gauge the efficacy of a treatment over a period ranging from 14 weeks to 40 weeks, and will track changes in patients' PTSD Checklist for DSM-5 (PCL-5) scores. Additionally, secondary outcomes such as improvement on the Social and Occupational Functioning Assessment Scale (SOFAS), Patient Health Questionnaire depression module's (PHQ-9) readings, and Quick Inventory of Depressive Symptoms - clinician rated (QIDS-C) results are also being monitored."

Answered by AI

Is this a pioneering medical trial?

"Fifteen studies for Prolonged Exposure Therapy are running across five nations' 20 cities, with the initial trial commencing in 2013. Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd., this Phase 2 & 3 drug approval undertaking engaged 300 individuals and concluded successfully. Subsequent to that inaugural experiment, 210 additional experiments have been conducted so far."

Answered by AI

Could I potentially join this clinical experiment?

"Participants with post traumatic stress disorder (PTSD) in the age range of 18 to 75 are eligible for this clinical trial, which requires 450 participants."

Answered by AI

Has the FDA validated Prolonged Exposure Therapy as an acceptable treatment?

"Due to its acceptance as a legitimate therapeutic option, Prolonged Exposure Therapy was ranked 3 on our team's scale. This is reflective of the fact that it has completed Phase 4 trials and is officially sanctioned by medical boards."

Answered by AI

Could you please provide a synopsis of the research that has been conducted using Prolonged Exposure Therapy?

"Currently, 15 trials for Prolonged Exposure Therapy are underway with 4 of those in their final stage. Most notably, the research is centered around Philadelphia but 30 other locations have been identified to run such studies as well."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
Other
Wisconsin
What site did they apply to?
Corporal Michael J. Crescenz VA Medical Center
Other
Milwaukee VA Medical Center
VA North Texas Healthcare System
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0
3+

Why did patients apply to this trial?

Interested seeing if this helps. Curious about these treatment options. I struggle with relationships and jobs.
PatientReceived 1 prior treatment
I have struggled with complex ptsd from a do. I have ptsd n would like to handle it better.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many appointments in a week? How long does screening take? Are there any risks?
PatientReceived no prior treatments
How frequently are we required to be at the testing facility? How long are the visits. Can I do any on the phone? Do I do them all at the medical office? Do you pay for this trial? How much?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Milwaukee VA Medical Center: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
Contemporary Clinical TrialsJournal
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best and for Whom; Study Protocol for a Randomized Trial
Bredemeier, Keith, Sadie Larsen, Geetha Shivakumar, Kathleen Grubbs, Carmen McLean, Carmella Tress, David Rosenfield, et al.. 2022. “A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best and for Whom; Study Protocol for a Randomized Trial”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106850.
Contemporary Clinical TrialsJournal
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best and for Whom; Study Protocol for a Randomized Trial
Bredemeier, Keith, Sadie Larsen, Geetha Shivakumar, Kathleen Grubbs, Carmen McLean, Carmella Tress, David Rosenfield, et al.. 2022. “A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best and for Whom; Study Protocol for a Randomized Trial”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106850.
Contemporary Clinical TrialsJournal
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best and for Whom; Study Protocol for a Randomized Trial
Bredemeier, Keith, Sadie Larsen, Geetha Shivakumar, Kathleen Grubbs, Carmen McLean, Carmella Tress, David Rosenfield, et al.. 2022. “A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best and for Whom; Study Protocol for a Randomized Trial”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2022.106850.
clinicaltrials.govStudy
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD
2022. "A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04961190.
All > Ptsd Anaheim > Effexor
~127 spots leftby Feb 2025
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