26 Participants Needed

Sertraline for PTSD

(SSRI Trial)

Recruiting at 1 trial location
SP
AR
Overseen ByAnn Rasmusson, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: VA Office of Research and Development
Must be taking: SSRIs
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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

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.

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

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
Trial Overview 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.
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).

Sertraline is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Zoloft for:
  • Depression
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder
  • Post-traumatic stress disorder (PTSD)
  • Premenstrual dysphoric disorder (PMDD)
  • Social anxiety disorder
🇪🇺
Approved in European Union as Sertraline for:
  • Major depressive episodes
  • Panic disorder
  • Obsessive compulsive disorder
  • Social anxiety disorder
  • Post traumatic stress disorder
  • Premenstrual dysphoric disorder

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+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Middlebury College

Collaborator

Trials
1
Recruited
90+

Ralph H. Johnson VA Medical Center

Collaborator

Trials
21
Recruited
5,700+

Findings from Research

In a pilot study involving 42 Israeli military veterans with PTSD, sertraline showed a numeric advantage over placebo in reducing PTSD symptoms, although this was not statistically significant in the overall analysis.
Sertraline was well tolerated with a low discontinuation rate of 13% due to adverse events, suggesting it may be a viable treatment option for combat-induced PTSD, but further studies are needed to confirm its efficacy.
Double-blind placebo-controlled pilot study of sertraline in military veterans with posttraumatic stress disorder.Zohar, J., Amital, D., Miodownik, C., et al.[2019]
Sertraline is an effective treatment for post-traumatic stress disorder (PTSD), offering advantages over older antidepressants, including better tolerability and a lower risk of overdose lethality.
Due to its efficacy, favorable side effect profile, and minimal interaction with the cytochrome P450 system, sertraline is recommended as a first-line treatment option for PTSD.
Review of sertraline in post-traumatic stress disorder.Schwartz, AC., Rothbaum, BO.[2022]
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]

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]
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