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Selective Serotonin Reuptake Inhibitor
Sertraline for PTSD (SSRI Trial)
Phase 4
Recruiting
Led By Suzanne Pineles, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Interest in starting a trial of an SSRI
Study psychiatrist's judgment that SSRIs are an acceptable treatment option for the participant's presenting concerns
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14
Awards & highlights
SSRI Trial Summary
This trial is testing a brief screening to see if it can predict which people with PTSD or depression will respond well to SSRI medications. 94 people are needed for the 17 week study.
Who is the study for?
This trial is for veterans with PTSD or major depression who've experienced trauma, meet DSM-5 criteria for these conditions, and are open to trying SSRI medication. They shouldn't have a severe substance use disorder, be at immediate risk of harm to self or others, have used certain serotonin-affecting drugs recently, be pregnant, or currently in specific psychotherapies.Check my eligibility
What is being tested?
The study tests if a brief screening can predict positive responses to SSRIs in those with PTSD or depression. Participants will either receive the SSRI sertraline or a placebo over 17 weeks to assess the effectiveness of this prediction method.See study design
What are the potential side effects?
Sertraline may cause side effects like nausea, sleep issues, tremors, dizziness, dry mouth, loss of appetite and sexual side effects. Placebos typically don't cause side effects but any symptoms reported by participants receiving it will be noted.
SSRI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am interested in trying an SSRI medication.
Select...
A psychiatrist agrees SSRIs are suitable for my mental health issues.
Select...
I have been diagnosed with PTSD, subthreshold PTSD, or major depression.
SSRI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change
Secondary outcome measures
Depression Anxiety Stress Scales (DASS-21) Change
Hamilton Depression Rating Scale (HAM-D) Change
PTSD Checklist for DSM-5 (PCL-5) Change
+3 moreSSRI Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Sertraline armActive Control3 Interventions
After the 2-week placebo lead-in phase, placebo-non responders will receive sertraline 25 mg daily for 2 weeks. Thereafter, sertraline will be increased flexibly by 25 to 50 mg per day (at a rate no higher than 50 mg per week) to achieve a total daily dose of 50 to 200 mg, based on clinical response and tolerability, with a maximum dose of 200 mg/d. Subjects unable to tolerate higher doses may be dropped back to the previous dose and remain at that dose for the remainder of the study.
Group II: Placebo only armPlacebo Group2 Interventions
For individuals who are placebo responders during the 2 week placebo lead in phase, they will remain on placebo for the duration of the study (i.e., the 12 weeks where the placebo non-responders are taking sertraline).
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,261 Total Patients Enrolled
Middlebury CollegeUNKNOWN
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,509 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe liver, kidney, or other unstable health conditions.I have significant issues with my nervous system.I have a history of bipolar I, schizophrenia, or another psychotic disorder.I have tried sertraline before and it didn't work for me.I am interested in trying an SSRI medication.You have a serious problem with drugs or alcohol.You are currently at risk of harming yourself or others.You are allergic or have a bad reaction to sertraline.I haven't taken drugs for serotonin issues in the last 3 months.You are currently participating in therapy specifically focused on trauma.I do not have a severe brain injury or any condition faking illness.A psychiatrist agrees SSRIs are suitable for my mental health issues.I have been on a stable dose of psychiatric medication for 3 months.You have experienced a traumatic event that meets the criteria for PTSD according to the DSM-5.I have been diagnosed with PTSD, subthreshold PTSD, or major depression.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo only arm
- Group 2: Sertraline arm
Awards:
This trial has 2 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree does the Sertraline arm of this research present a hazard to individuals?
"There is existing approval for Sertraline, making it a safe option and receiving a score of 3."
Answered by AI
What is the maximum number of participants for this research project?
"Indeed, clinicaltrials.gov reports that this research is still looking for participants. This study was introduced on September 11th 2019 and has most recently been updated on March 9th 2022; 94 individuals will be recruited from one single location."
Answered by AI
What qualifications must a person possess to partake in this clinical research?
"To qualify for this clinical trial, applicants must have a documented case of post traumatic stress disorder and be between the ages of 18-70. Currently, a total of 94 patients are being sought after."
Answered by AI
What mental health issues is Sertraline arm frequently prescribed for?
"Sertraline arm is often employed to treat premenstrual dysphoric disorder and can prove useful in treating anxiety disorders, binge eating disorder (BED), and obsessive-compulsive disorder."
Answered by AI
Does this clinical trial extend to elderly adults, aged 65 or above?
"The trial is open to any individuals aged 18 or over and under the age of 70."
Answered by AI
Is registration still open for this research trial?
"This clinical trial is presently recruiting, as reported on the clinicaltrials.gov website. The initial post date was September 11th 2019 and it has been updated most recently on March 9th 2022."
Answered by AI
Who else is applying?
What site did they apply to?
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
What questions have other patients asked about this trial?
What is it in its entirety?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA: < 48 hours
Average response time
- < 2 Days
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