Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-11 @ 2:50 PM
Study NCT ID:
NCT04183205
Status:
TERMINATED
Last Update Posted:
2025-04-10
First Post:
2019-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting SSRI Efficacy in Veterans With PTSD
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
An Electrophysiological Predictor of SSRI Response in Veterans With PTSD
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty meeting recruitment goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSRI
Brief Summary:
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.
Detailed Description:
Selective serotonin reuptake inhibitors (SSRIs) are prescribed to approximately 60% of Veterans with PTSD treated within the Veterans Health Administration (VHA). However, many patients are not responsive to SSRIs. Currently, there is no way to determine whether a particular patient will benefit from an SSRI; treatment is primarily accomplished through 'trial and error' over several weeks or months. The overarching goal of this study is to investigate the pre-treatment usefulness of a simple electrophysiological test for predicting the likelihood of a favorable response to an SSRI. This study will investigate whether a brief pre-treatment auditory event-related potentials procedure \[referred to going forward as "Loudness Dependence of Auditory Evoked Potentials" (LDAEP)\] offers a means for predicting treatment response to an SSRI for men and women diagnosed with PTSD or depression.
This study has four aims: 1) To determine the strength of the relationship between LDAEP and clinical response to SSRI treatment. 2) To determine LDAEP cut-off values that would enable clinicians to make individualized SSRI treatment recommendations. 3) To assess the usefulness of change in LDAEP as an objective measure of SSRI response. 4) Exploratory: To determine whether the relationship between LDAEP and clinical response to sertraline differs between men and women.
Means to Protect Subjects' Identities:
To ensure confidentiality, questionnaire and interview data will be stored in locked filing cabinets within locked offices. Each participant will have his or her own participant number and these numbers will be the only means by which participant information can be identified. Electronic data will be stored on a secure private, password-protected drive that can only be accessed by members of the study team and labeled only with the participant number. One list of names and participant numbers will be kept on a private, password-protected computer account on a separate drive from the de-identified data and accessible only to the study team.
ADMINISTRATION OF DRUGS IN RESEARCH NOT FUNDED BY NIH Description Of Identification Of Drug: SERTRALINE. Because the goal of this study is to identify pre-treatment predictors of SSRI response that ultimately could be used in routine clinical care, the investigators designed the study with ecological validity in mind. Specifically, the investigators chose sertraline as the study medication because it is: a) the most commonly prescribed SSRI in the US, b) one of only two FDA-approved drugs for treating PTSD, and c) one of the two most effective SSRIs for major depression, a common comorbidity with PTSD. Dosing will follow clinical practice guidelines, i.e., doses will be chosen based on clinical response and tolerability.
Description Of Administration Of Drug: The investigators are using an approach , which represents enhanced clinical care in that participants discuss medication levels, side effects, and symptoms with a psychiatrist every two weeks. Study medication and placebo will be stored and distributed by VA Boston Pharmacy service.
This study has four aims: 1) To determine the strength of the relationship between LDAEP and clinical response to SSRI treatment. 2) To determine LDAEP cut-off values that would enable clinicians to make individualized SSRI treatment recommendations. 3) To assess the usefulness of change in LDAEP as an objective measure of SSRI response. 4) Exploratory: To determine whether the relationship between LDAEP and clinical response to sertraline differs between men and women.
Means to Protect Subjects' Identities:
To ensure confidentiality, questionnaire and interview data will be stored in locked filing cabinets within locked offices. Each participant will have his or her own participant number and these numbers will be the only means by which participant information can be identified. Electronic data will be stored on a secure private, password-protected drive that can only be accessed by members of the study team and labeled only with the participant number. One list of names and participant numbers will be kept on a private, password-protected computer account on a separate drive from the de-identified data and accessible only to the study team.
ADMINISTRATION OF DRUGS IN RESEARCH NOT FUNDED BY NIH Description Of Identification Of Drug: SERTRALINE. Because the goal of this study is to identify pre-treatment predictors of SSRI response that ultimately could be used in routine clinical care, the investigators designed the study with ecological validity in mind. Specifically, the investigators chose sertraline as the study medication because it is: a) the most commonly prescribed SSRI in the US, b) one of only two FDA-approved drugs for treating PTSD, and c) one of the two most effective SSRIs for major depression, a common comorbidity with PTSD. Dosing will follow clinical practice guidelines, i.e., doses will be chosen based on clinical response and tolerability.
Description Of Administration Of Drug: The investigators are using an approach , which represents enhanced clinical care in that participants discuss medication levels, side effects, and symptoms with a psychiatrist every two weeks. Study medication and placebo will be stored and distributed by VA Boston Pharmacy service.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: