Predicting SSRI Efficacy in Veterans With PTSD
Key facts
- Who runs it
- VA Office of Research and Development
- Where
- Boston and Charleston, United StatesSee the 2 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 4
- People taking part
- 19 people enrolled
- Started
- 11 Sept 2019
- Ended
- 31 Mar 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- LDAEP
- Placebo
- sertraline
- Record updated
- 17 June 2026
- Why it stopped
- difficulty meeting recruitment goals
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- use of drugs that directly affect the serotonin system (e.g., SNRIs, antipsychotics) within 3 months of the study
- use of an SSRI within 3 months of the study. Use of other psychotropic medications must have been stable for 3 months prior to enrollment and remain stable throughout participation
- current or past history of bipolar I disorder, schizophrenic or other psychotic disorders
- current organic brain disorder including severe traumatic brain injury, factitious disorder, or malingering
- current moderate or severe substance use disorder
- evidence of clinically significant hepatic or renal disease or any other acute or unstable medical condition that might interfere with safe conduct of the study
- intolerance or hypersensitivity to sertraline
- hearing impairment for 780 Hz tones
- for those participants who currently have a non-VA or VA psychiatrist or primary care provider who is willing to prescribe medications, they must be willing to sign a release of information (ROI) for study staff to communicate with their providers and the provider believes that including the participant in the study is potentially appropriate; As discussed above, the investigators will inform the participant that the investigators will share the following information with their current relevant care provider:; information about the design of the study, inclusion and exclusion criteria, the participant's psychiatric and medical diagnoses as well as illness severity, as assessed in the screening evaluation, and any history of safety issues such as risk to self or others; If the participant doesn't sign a release of release of information (ROI) to contact the provider, the participant will not be entered into the active study
- pregnancy
- major neurological problems
- active risk to self or others
- failed past trial of sertraline (confirmed by medical record review)
- current enrollment in trauma-focused psychotherapy
Where in United States
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, United States
- Ralph H. Johnson VA Medical Center, Charleston, SCCharleston, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Placebo only armPlacebo, for comparison
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).
Treatment: LDAEP and Placebo
- Sertraline armExisting treatment, for comparison
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.
Treatment: LDAEP, Placebo, and sertraline
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Electrophysiological Predictor of SSRI Response in Veterans With PTSD
- Record updated
- 17 June 2026