Sertraline for PTSD
(SSRI Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
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?
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
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).
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
Research Locations NearbySelect from list below to view details:
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, MA
Ralph H. Johnson VA Medical Center, Charleston, SCCharleston, SC
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
Massachusetts General HospitalCollaborator
Middlebury CollegeCollaborator
Ralph H. Johnson VA Medical CenterCollaborator
References
Double-blind placebo-controlled pilot study of sertraline in military veterans with posttraumatic stress disorder. [2019]The efficacy of sertraline in the treatment of civilian posttraumatic stress disorder (PTSD) has been established by two large placebo-controlled trials. The purpose of the current pilot study was to obtain preliminary evidence of the efficacy of sertraline in military veterans suffering from PTSD. Outpatient Israeli military veterans with a DSM-III-R diagnosis of PTSD were randomized to 10 weeks of double-blind treatment with sertraline (50-200 mg/day; N = 23, 83% male, mean age = 41 years) or placebo (N = 19, 95% male, mean age = 38 years). Efficacy was evaluated by the Clinician-Administered PTSD Scale (CAPS-2) and by Clinical Global Impression Scale-Severity (CGI-S) and -Improvement (CGI-I) ratings. Consensus responder criteria consisted of a 30% or greater reduction in the CAPS-2 total severity score and a CGI-I rating of "much" or "very much" improved. The baseline CAPS-2 total severity score was 94.3 +/- 12.9 for sertraline patients, which is notably higher than that reported for most studies of civilian PTSD. On an intent-to-treat endpoint analysis, sertraline showed a numeric but not statistically significant advantage compared with placebo on the CAPS-2 total severity and symptom cluster scores. In the study completer analysis, the mean CGI-I score was 2.4 +/- 0.3 for sertraline and 3.4 +/- 0.3 for placebo (t = 2.55, df = 30, p = 0.016), CGI-I responder rates were 53% for sertraline and 20% for placebo (chi2 = 3.62, df = 1, p = 0.057), and combined CGI-I and CAPS-2 responder rates (>or=30% reduction in baseline CAPS-2 score) were 41% for sertraline and 20% for placebo (chi2 = 1.39, df = 1, p = 0.238). Sertraline treatment was well tolerated, with a 13% discontinuation rate as a result of adverse events. This pilot study suggests that sertraline may be an effective treatment in patients with predominantly combat-induced PTSD, although the effect size seems to be somewhat smaller than what has been reported in civilian PTSD studies. Adequately powered studies are needed to confirm these results and to assess whether continued treatment maintains or further improves response.
Review of sertraline in post-traumatic stress disorder. [2022]Sertraline (Zoloft trade mark, Pfizer) is a selective serotonin re-uptake inhibitor (SSRI) with proven efficacy in the treatment of post-traumatic stress disorder (PTSD). PTSD is a serious, complex and often chronic mental illness that may follow exposure to a traumatic event. The high prevalence of traumatic events and PTSD in the general population and the resulting distress and dysfunction present a need for the systematic study of the efficacy and effectiveness of treatments for PTSD. Sertraline offers advantages over the older antidepressants, including demonstrated efficacy in PTSD, improved tolerability and low risk of lethality in overdose. Sertraline's efficacy, favourable tolerability profile and relatively weak effect on the cytochrome P450 system are factors that contribute to make it a first-line agent of choice in the treatment of PTSD.
Affective and anxiety comorbidity in post-traumatic stress disorder treatment trials of sertraline. [2015]Comorbidity of mood and anxiety disorders is common in patients suffering from post-traumatic stress disorder (PTSD). The current study evaluated the efficacy and tolerability of sertraline in a subgroup of PTSD patients suffering from anxiety or depression comorbidity. Two multicenter, 12-week, double-blind, flexible-dose US studies of adult outpatients from the general population with a DSM-III-R diagnosis of PTSD evaluated the safety and efficacy of sertraline (50 to 200 mg/d) compared to placebo in the treatment of PTSD. The total severity score of the Clinician-Administered PTSD Scale (CAPS-2) and the Davidson Trauma Scale (DTS) were used to examine the effect of comorbidity on treatment outcome. Among the combined 395 subjects enrolled in the two trials, 32.9% had a comorbid depressive diagnosis (no anxiety diagnosis), 6.3% had a comorbid anxiety disorder diagnosis (no depression), 11.4% had both a depression and anxiety disorder diagnosis, and 49.4% had no comorbidity. The correlation, at baseline, between Hamilton Depression Rating Scale (HAM-D) total score and the three CAPS-2 clusters was 0.37 for the re-experiencing/intrusion cluster, 0.52 for the avoidance/numbing cluster, and 0.45 for the hyperarousal cluster. Patients suffering from PTSD complicated by a current diagnosis of both depression and an anxiety disorder showed the highest baseline CAPS-2 cluster score severity. Patients treated with sertraline improved significantly (P
COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL. [2022]Combined treatment with a selective serotonin reuptake inhibitor (SSRI) plus mirtazapine has shown superior efficacy in some studies of depression, but has not been studied in posttraumatic stress disorder (PTSD). This study aimed to assess acceptability of combined sertraline plus mirtazapine treatment for PTSD and to estimate its effect size relative to sertraline plus placebo.
Effect and safety of sertraline for treat posttraumatic stress disorder: a multicenter randomised controlled study. [2022]Although several previous studies have examined the efficacy of sertraline in the treatment of posttraumatic stress disorder (PTSD), none involved Chinese PTSD patients. This study aimed to evaluate sertraline efficacy and adverse events in Chinese patients with PTSD over 12 weeks.
Sertraline treatment of children and adolescents with posttraumatic stress disorder: a double-blind, placebo-controlled trial. [2022]The aim of this study was to evaluate the safety and efficacy of sertraline in children and adolescents who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for posttraumatic stress disorder (PTSD).
Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study. [2022]Many of the posttraumatic stress disorder (PTSD) treatment guidelines recognize the use of selective serotonin reuptake inhibitors as first-line pharmacological treatment. In Japan, there were no published studies investigating the effectiveness and safety of sertraline for PTSD in a clinical setting.
Characterizing the effects of sertraline in post-traumatic stress disorder. [2019]Sertraline has a proved efficacy in post-traumatic stress disorder (PTSD), but it is unknown which symptoms respond or in what sequence this occurs. Such information might be useful clinically and heuristically.