Predicting SSRI Efficacy in Veterans With PTSD (NCT04183205) | Clinical Trial Compass
TerminatedPhase 4
Predicting SSRI Efficacy in Veterans With PTSD
Stopped: difficulty meeting recruitment goals
United States19 participantsStarted 2019-09-11
Plain-language summary
This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) or depression are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 5.25 years, until at least 94 participants complete the 17 week study.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. has a history of trauma exposure as defined by criterion A of PTSD in the DSM-5
. meets diagnostic criteria for PTSD, subthreshold PTSD, or MDD as defined by DSM-5
. study psychiatrist's judgment that SSRIs are an acceptable treatment option for the participant's presenting concerns, and
. interest in starting a trial of an SSRI
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect whether the brain-wave biomarker approach it was testing is still considered a valid or promising way to predict whether an SSRI might work for my PTSD?
2The study was trying to use a pre-treatment EEG brain signal called LDAEP to predict how someone would respond to an SSRI after 14 weeks — is that kind of brain-based prediction tool available or useful in my care right now, or is it still purely experimental?
3Since this trial was terminated and didn't complete its full data collection, would my doctor consider a standard 14-week SSRI trial for my PTSD and depression to be a reasonable next step on its own, without waiting for this type of biomarker research to mature?
4This trial enrolled veterans with both PTSD and major depressive disorder — given that I may have one or both of those conditions, how does my specific diagnosis affect which medication options or studies might actually be relevant for me to explore?
5Because this study was terminated, is there another active trial or established clinical pathway my doctor knows of that uses measurable biological markers to guide SSRI treatment decisions for PTSD, so we aren't just relying on trial and error with medications?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the PZ Site) and Controlling for Baseline CAPS Score
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
2
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the CZ Site) and Controlling for Baseline CAPS Score
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
3
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial as Predicted by Pretreatment LDAEP Slope (Calculated With P200 at the FZ Site) and Controlling for Baseline CAPS Score
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
4
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the PZ Site) and Controlling for Baseline CAPS Score
Timeframe: CAPS score administered 14 weeks after starting the medication trial, controlling for baseline CAPS score
5
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) After 14 Weeks of the Medication Trial Predicted by Pretreatment LDAEP Slope (Calculated With N100 at the CZ Site) and Controlling for Baseline CAPS Score