~4 spots leftby Apr 2026

Sertraline for PTSD

(SSRI Trial)

Recruiting in Palo Alto (17 mi)
+1 other location
SP
Overseen bySuzanne Pineles, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: VA Office of Research and Development
Must be taking: SSRIs
Must not be taking: SNRIs, Antipsychotics
Disqualifiers: Bipolar, Schizophrenia, Pregnancy, others
Prior Safety Data
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you have not used SSRIs or drugs affecting the serotonin system for 3 months before starting. Other psychotropic medications must be stable for 3 months before and during the study.

What data supports the effectiveness of the drug sertraline for treating PTSD?

Research shows that sertraline, a type of antidepressant, has been effective in treating PTSD in both civilian and military populations. It is well-tolerated and offers advantages over older antidepressants, making it a preferred choice for PTSD treatment.12345

Is sertraline safe for humans?

Sertraline, also known as Zoloft, has been studied for safety in various clinical trials for PTSD, showing it is generally well-tolerated with some patients experiencing mild side effects. In one study, only 13% of participants stopped using it due to adverse effects, indicating it is relatively safe for human use.13567

How does the drug sertraline differ from other treatments for PTSD?

Sertraline is unique because it is a selective serotonin reuptake inhibitor (SSRI), which helps increase serotonin levels in the brain to improve mood and reduce anxiety, and it is one of the few drugs approved specifically for PTSD. It is also effective for patients with PTSD who have additional mood or anxiety disorders, making it versatile for those with multiple conditions.34678

Research Team

SP

Suzanne Pineles, PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Eligibility Criteria

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.

Inclusion Criteria

I am interested in trying an SSRI medication.
A psychiatrist agrees SSRIs are suitable for my mental health issues.
You have experienced a traumatic event that meets the criteria for PTSD according to the DSM-5.
See 1 more

Exclusion Criteria

Pregnancy
I do not have any severe liver, kidney, or other unstable health conditions.
I have significant issues with my nervous system.
See 11 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Placebo Lead-in

Participants undergo a 2-week placebo lead-in phase to identify placebo responders

2 weeks
1 visit (in-person)

Treatment

Placebo non-responders receive sertraline, with dose adjustments based on clinical response and tolerability

12 weeks
Bi-weekly visits (in-person) with psychiatrist check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Sertraline (Selective Serotonin Reuptake Inhibitor)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+
Dr. Grant Huang profile image

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella profile image

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski profile image

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Middlebury College

Collaborator

Trials
1
Recruited
90+

Ralph H. Johnson VA Medical Center

Collaborator

Trials
21
Recruited
5,700+

Findings from Research

In a study of 395 PTSD patients, sertraline was found to be effective and well tolerated, significantly improving PTSD symptoms compared to placebo, regardless of whether patients had comorbid anxiety or depression.
Patients with both depression and anxiety disorders showed the highest severity of PTSD symptoms at baseline and benefited from slightly higher doses of sertraline, indicating that comorbidity may influence treatment response.
Affective and anxiety comorbidity in post-traumatic stress disorder treatment trials of sertraline.Brady, KT., Clary, CM.[2015]
In a study of 36 adults with PTSD, combining sertraline (an SSRI) with mirtazapine resulted in a significantly higher remission rate and greater improvement in depressive symptoms compared to sertraline plus placebo over 24 weeks.
Both treatment options were well-tolerated, with the combined treatment showing some increased appetite but no significant weight gain, suggesting it may be a viable option for improving symptoms in PTSD patients.
COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL.Schneier, FR., Campeas, R., Carcamo, J., et al.[2022]
In a study of 122 Japanese patients with PTSD treated with sertraline for an average of 10.6 months, 50% were considered responders, and 65.6% showed improvement in PTSD severity, indicating sertraline's effectiveness in this population.
The safety profile of sertraline was consistent with known data, with no serious adverse events reported, suggesting it is a safe option for treating PTSD in clinical practice.
Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study.Kamo, T., Maeda, M., Oe, M., et al.[2022]

References

Double-blind placebo-controlled pilot study of sertraline in military veterans with posttraumatic stress disorder. [2019]
Review of sertraline in post-traumatic stress disorder. [2022]
Affective and anxiety comorbidity in post-traumatic stress disorder treatment trials of sertraline. [2015]
COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL. [2022]
Effect and safety of sertraline for treat posttraumatic stress disorder: a multicenter randomised controlled study. [2022]
Sertraline treatment of children and adolescents with posttraumatic stress disorder: a double-blind, placebo-controlled trial. [2022]
Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study. [2022]
Characterizing the effects of sertraline in post-traumatic stress disorder. [2019]