Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression
NCT ID: NCT01407094
Last Updated: 2018-12-26
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
296 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-07-29
Study Completion Date
2016-04-30
Brief Summary
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This study will examine multiple carefully selected clinical and biological markers, using both existing state-of-the-art technologies as well as pioneering, innovative approaches. The study is designed to identify moderators and mediators of treatment response for depression in order to specify a biosignature of treatment response for depression. Evaluation of the usefulness of these markers in a carefully conducted clinical trial comparing an antidepressant to placebo will assist in developing a Depression Treatment Response Index (DTRI) to help clinicians match treatments to patients with MDD, resulting in timely selection of treatments best suited for individual patients and thus approaching personalized treatment. The resulting index provides a truly novel means of synthesizing the contribution of key clinical and biological parameters in an easy to use tool for clinical care.
Detailed Description
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The current study is designed to identify biomarkers for the prediction of differential treatment outcomes between the SSRI antidepressant sertraline (SERT) and placebo (PBO) in a randomized trial for patients with MDD. In addition, a second stage will collect data to explore moderators and mediators of treatment outcomes between pharmacologically distinct active treatment arms: sertraline (SERT), a serotonergic antidepressant or bupropion (BUP), a nonserotonergic antidepressant. To reduce biologic heterogeneity, we will only enroll patients with early onset of DSM IV MDD (before age 30) because these criteria in probands have been shown to be associated with increased familial loading in families. Patients will also have recurrent MDD with 2 or more recurrences (including current episode). Additionally, patients will be required to have a current symptom severity score of 14 or more on the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR), both at study screening and at the randomization (baseline) visit. In the first stage, patients will receive an 8-week course of treatment in one of the two study arms. As part of the Sequential Multiple Assignment Randomized Trial (SMART) design patients that have not achieved a response at the end of 8 weeks to their stage one treatment, defined by \< 50% improvement on the Clinical Global Improvement scale (CGI), will be switched to Stage 2 treatment (8 weeks). Patients who have achieved satisfactory response (\>= 50% improvement on the CGI) will be continued on treatment for an additional 8 weeks.
Specific Aims
Moderator Aims (Aim 1): To identify baseline clinical, neuroimaging, neurophysiological, and behavioral moderators of differential treatment outcome (mean symptom change and tolerability) for sertraline (SERT, a serotonergic antidepressant) versus placebo (PBO) for the treatment of MDD. Symptom change will be measured using the mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD17). Tolerability will be measured using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) and the Treatment Emergent Symptom Scale (TESS).
Mediator Aims (Aim 2): To identify early phase (week 1) changes in neuroimaging, neurophysiological, and behavioral tasks as mediators of differential treatment outcomes (symptom change, tolerability) to SERT and PBO.
Main Treatment Effects Aim (Aim 3): To compare the 8-week outcomes of SERT vs. PBO using mixed model regression analysis to maximize power to discriminate treatment efficacy differences.
Primary Outcomes:
\- 17-item Hamilton Rating Scale for Depression (HRSD17)
Secondary Outcomes:
\- the Frequency, Intensity, and Burden Side Effects Rating (FIBSER)
Specific Aims
Moderator Aims (Aim 1): To identify baseline clinical, neuroimaging, neurophysiological, and behavioral moderators of differential treatment outcome (mean symptom change and tolerability) for sertraline (SERT, a serotonergic antidepressant) versus placebo (PBO) for the treatment of MDD. Symptom change will be measured using the mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD17). Tolerability will be measured using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) and the Treatment Emergent Symptom Scale (TESS).
Mediator Aims (Aim 2): To identify early phase (week 1) changes in neuroimaging, neurophysiological, and behavioral tasks as mediators of differential treatment outcomes (symptom change, tolerability) to SERT and PBO.
Main Treatment Effects Aim (Aim 3): To compare the 8-week outcomes of SERT vs. PBO using mixed model regression analysis to maximize power to discriminate treatment efficacy differences.
Primary Outcomes:
\- 17-item Hamilton Rating Scale for Depression (HRSD17)
Secondary Outcomes:
\- the Frequency, Intensity, and Burden Side Effects Rating (FIBSER)
Conditions
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Depression
Keywords
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Depression, Major Depressive Disorder, Mood Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Patients were entered into Stage 1, treated with sertraline (Treatment A) or placebo (Treatment B), and used for the primary analysis which included the identification of potential mediators and moderators of response for these two treatments.
In stage two, responders to Treatment A remained on sertraline, and non-responders were switched to bupropion (Treatment C). Responders to Treatment B remained on placebo, and non-responders were switched to sertraline (Treatment D).
In stage two, responders to Treatment A remained on sertraline, and non-responders were switched to bupropion (Treatment C). Responders to Treatment B remained on placebo, and non-responders were switched to sertraline (Treatment D).
Primary Study Purpose
OTHER
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Sertraline
SSRI monotherapy
Group Type
ACTIVE_COMPARATOR
Sertraline
Intervention Type
DRUG
50-200mg/day
Placebo
Placebo control
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
1-4 pills per day
Bupropion
BupropionXL
Group Type
ACTIVE_COMPARATOR
BupropionXL
Intervention Type
DRUG
150-450 mg/day
Interventions
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Sertraline
50-200mg/day
Intervention Type
DRUG
Placebo
1-4 pills per day
Intervention Type
DRUG
BupropionXL
150-450 mg/day
Intervention Type
DRUG
Other Intervention Names
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Zoloft
WelbutrinXL
Eligibility Criteria
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Inclusion Criteria
* Adults, age 18-65
* Written informed consent obtained
* Outpatients with a current primary diagnosis of nonpsychotic recurrent or chronic MDD per the SCID-I
* QIDS-SR score of ≥ 14 at Screening Visit and Randomization (Baseline) Visit
* No failed antidepressant trials of adequate dose and duration, as defined by the MGH-ATRQ, in the current episode
* Agrees to, and is eligible for, all biomarkers procedures (EEG/psychological testing, MRI, and blood draws)
* Written informed consent obtained
* Outpatients with a current primary diagnosis of nonpsychotic recurrent or chronic MDD per the SCID-I
* QIDS-SR score of ≥ 14 at Screening Visit and Randomization (Baseline) Visit
* No failed antidepressant trials of adequate dose and duration, as defined by the MGH-ATRQ, in the current episode
* Agrees to, and is eligible for, all biomarkers procedures (EEG/psychological testing, MRI, and blood draws)
Exclusion Criteria
* History of inadequate response (to trials at adequate dose for adequate duration) or poor tolerability to sertraline (SERT) or bupropion (BUP)
* Pregnant or breastfeeding
* Plan to become pregnant over the ensuing 12 months following study entry or are sexually active and not using adequate contraception
* History (lifetime) of psychotic depression, schizophrenia, bipolar (I, II, or NOS) disorder, schizoaffective disorder, or other Axis I psychotic disorder
* Current primary anxiety disorder diagnosis
* Meeting DSM-IV criteria for substance abuse in the last 2 months or substance dependence in the last 6 months (except for nicotine)
* Require immediate hospitalization for psychiatric disorder
* Have an unstable general medical condition (GMC) that will likely require hospitalization or to be deemed terminal (life expectancy \< 6 months after study entry)
* Require medications for their GMCs that contraindicate any study medication
* Have epilepsy or other conditions requiring an anticonvulsant
* Receiving or have received during the index episode vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatments
* Currently taking any of the following exclusionary medications: antipsychotic medications, anticonvulsant medications, mood stabilizers, central nervous system stimulants, daily use of benzodiazepines or hypnotics, or antidepressant medication used for the treatment of depression or other purposes such as smoking cessation, since these agents may interfere with the testing of the major hypotheses under study. Nonexcluded concomitant medications are acceptable as long as their clinician determines that antidepressant treatment is safe and appropriate.
* Significant liver disease that would contraindicate any study medication
* Taking thyroid medication for hypothyroidism may be included only if they have been stable on the thyroid medication for 3 months
* Using agents that are potential augmenting agents (e.g., T3 in the absence of thyroid disease, SAMe, St. John's Wort, lithium, buspirone, Omega 3 fatty acids)
* Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of Depression (IPT) is not allowed during participation (participants can participate if they are receiving psychotherapy that is not targeting the symptoms of depression, such as supportive therapy, marital therapy).
* Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent since non-English speaking personnel are not available for this study, and the research instruments are not yet translated and validated in other languages.
* Currently actively suicidal or considered a high suicide risk
* Are currently enrolled in another study, and participation in that study contraindicates participation in the EMBARC study.
* Any reason not listed herein yet, determined by the site PI, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the site PI, medical personnel, or designee make participation in the study hazardous.
* Pregnant or breastfeeding
* Plan to become pregnant over the ensuing 12 months following study entry or are sexually active and not using adequate contraception
* History (lifetime) of psychotic depression, schizophrenia, bipolar (I, II, or NOS) disorder, schizoaffective disorder, or other Axis I psychotic disorder
* Current primary anxiety disorder diagnosis
* Meeting DSM-IV criteria for substance abuse in the last 2 months or substance dependence in the last 6 months (except for nicotine)
* Require immediate hospitalization for psychiatric disorder
* Have an unstable general medical condition (GMC) that will likely require hospitalization or to be deemed terminal (life expectancy \< 6 months after study entry)
* Require medications for their GMCs that contraindicate any study medication
* Have epilepsy or other conditions requiring an anticonvulsant
* Receiving or have received during the index episode vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatments
* Currently taking any of the following exclusionary medications: antipsychotic medications, anticonvulsant medications, mood stabilizers, central nervous system stimulants, daily use of benzodiazepines or hypnotics, or antidepressant medication used for the treatment of depression or other purposes such as smoking cessation, since these agents may interfere with the testing of the major hypotheses under study. Nonexcluded concomitant medications are acceptable as long as their clinician determines that antidepressant treatment is safe and appropriate.
* Significant liver disease that would contraindicate any study medication
* Taking thyroid medication for hypothyroidism may be included only if they have been stable on the thyroid medication for 3 months
* Using agents that are potential augmenting agents (e.g., T3 in the absence of thyroid disease, SAMe, St. John's Wort, lithium, buspirone, Omega 3 fatty acids)
* Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of Depression (IPT) is not allowed during participation (participants can participate if they are receiving psychotherapy that is not targeting the symptoms of depression, such as supportive therapy, marital therapy).
* Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent since non-English speaking personnel are not available for this study, and the research instruments are not yet translated and validated in other languages.
* Currently actively suicidal or considered a high suicide risk
* Are currently enrolled in another study, and participation in that study contraindicates participation in the EMBARC study.
* Any reason not listed herein yet, determined by the site PI, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the site PI, medical personnel, or designee make participation in the study hazardous.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Madhukar H. Trivedi
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Madhukar H Trivedi, M.D.
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Patrick J McGrath, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Myrna Weissman, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Ramin Parsey, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Maurizio Fava, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Boston
Boston, Massachusetts, United States
Site Status
University of Michigan Ann Arbor
Ann Arbor, Michigan, United States
Site Status
Columbia Univerisity New York City
New York, New York, United States
Site Status
UT Southwestern Medical Center Dallas
Dallas, Texas, United States
Site Status
Countries
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United States
References
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Rolle CE, Fonzo GA, Wu W, Toll R, Jha MK, Cooper C, Chin-Fatt C, Pizzagalli DA, Trombello JM, Deckersbach T, Fava M, Weissman MM, Trivedi MH, Etkin A. Cortical Connectivity Moderators of Antidepressant vs Placebo Treatment Response in Major Depressive Disorder: Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2020 Apr 1;77(4):397-408. doi: 10.1001/jamapsychiatry.2019.3867.
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Pillai RLI, Huang C, LaBella A, Zhang M, Yang J, Trivedi M, Weissman M, McGrath P, Fava M, Kurian B, Cooper C, McInnis M, Oquendo MA, Pizzagalli DA, Parsey RV, DeLorenzo C. Examining raphe-amygdala structural connectivity as a biological predictor of SSRI response. J Affect Disord. 2019 Sep 1;256:8-16. doi: 10.1016/j.jad.2019.05.055. Epub 2019 May 28.
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Fournier JC, Chase HW, Greenberg T, Etkin A, Almeida JR, Stiffler R, Deckersbach T, Weyandt S, Cooper C, Toups M, Carmody T, Kurian B, Peltier S, Adams P, McInnis MG, Oquendo MA, McGrath PJ, Fava M, Weissman M, Parsey R, Trivedi MH, Phillips ML. Neuroticism and Individual Differences in Neural Function in Unmedicated Major Depression: Findings from the EMBARC Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2017 Mar;2(2):138-148. doi: 10.1016/j.bpsc.2016.11.008. Epub 2016 Dec 6.
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Greenberg T, Chase HW, Almeida JR, Stiffler R, Zevallos CR, Aslam HA, Deckersbach T, Weyandt S, Cooper C, Toups M, Carmody T, Kurian B, Peltier S, Adams P, McInnis MG, Oquendo MA, McGrath PJ, Fava M, Weissman M, Parsey R, Trivedi MH, Phillips ML. Moderation of the Relationship Between Reward Expectancy and Prediction Error-Related Ventral Striatal Reactivity by Anhedonia in Unmedicated Major Depressive Disorder: Findings From the EMBARC Study. Am J Psychiatry. 2015 Sep 1;172(9):881-91. doi: 10.1176/appi.ajp.2015.14050594. Epub 2015 Jul 17.
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Petkova E, Ogden RT, Tarpey T, Ciarleglio A, Jiang B, Su Z, Carmody T, Adams P, Kraemer HC, Grannemann BD, Oquendo MA, Parsey R, Weissman M, McGrath PJ, Fava M, Trivedi MH. Statistical Analysis Plan for Stage 1 EMBARC (Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care) Study. Contemp Clin Trials Commun. 2017 Jun;6:22-30. doi: 10.1016/j.conctc.2017.02.007. Epub 2017 Feb 24.
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Trivedi MH, South C, Jha MK, Rush AJ, Cao J, Kurian B, Phillips M, Pizzagalli DA, Trombello JM, Oquendo MA, Cooper C, Dillon DG, Webb C, Grannemann BD, Bruder G, McGrath PJ, Parsey R, Weissman M, Fava M. A Novel Strategy to Identify Placebo Responders: Prediction Index of Clinical and Biological Markers in the EMBARC Trial. Psychother Psychosom. 2018;87(5):285-295. doi: 10.1159/000491093. Epub 2018 Aug 15.
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Trivedi MH, McGrath PJ, Fava M, Parsey RV, Kurian BT, Phillips ML, Oquendo MA, Bruder G, Pizzagalli D, Toups M, Cooper C, Adams P, Weyandt S, Morris DW, Grannemann BD, Ogden RT, Buckner R, McInnis M, Kraemer HC, Petkova E, Carmody TJ, Weissman MM. Establishing moderators and biosignatures of antidepressant response in clinical care (EMBARC): Rationale and design. J Psychiatr Res. 2016 Jul;78:11-23. doi: 10.1016/j.jpsychires.2016.03.001. Epub 2016 Mar 15.
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Trombello JM, Pizzagalli DA, Weissman MM, Grannemann BD, Cooper CM, Greer TL, Malchow AL, Jha MK, Carmody TJ, Kurian BT, Webb CA, Dillon DG, McGrath PJ, Bruder G, Fava M, Parsey RV, McInnis MG, Adams P, Trivedi MH. Characterizing anxiety subtypes and the relationship to behavioral phenotyping in major depression: Results from the EMBARC study. J Psychiatr Res. 2018 Jul;102:207-215. doi: 10.1016/j.jpsychires.2018.04.003. Epub 2018 Apr 6.
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Ulke C, Tenke CE, Kayser J, Sander C, Bottger D, Wong LYX, Alvarenga JE, Fava M, McGrath PJ, Deldin PJ, Mcinnis MG, Trivedi MH, Weissman MM, Pizzagalli DA, Hegerl U, Bruder GE. Resting EEG Measures of Brain Arousal in a Multisite Study of Major Depression. Clin EEG Neurosci. 2019 Jan;50(1):3-12. doi: 10.1177/1550059418795578. Epub 2018 Sep 5.
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Webb CA, Trivedi MH, Cohen ZD, Dillon DG, Fournier JC, Goer F, Fava M, McGrath PJ, Weissman M, Parsey R, Adams P, Trombello JM, Cooper C, Deldin P, Oquendo MA, McInnis MG, Huys Q, Bruder G, Kurian BT, Jha M, DeRubeis RJ, Pizzagalli DA. Personalized prediction of antidepressant v. placebo response: evidence from the EMBARC study. Psychol Med. 2019 May;49(7):1118-1127. doi: 10.1017/S0033291718001708. Epub 2018 Jul 2.
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Chin Fatt CR, Minhajuddin A, Jha MK, Mayes T, Rush AJ, Trivedi MH. Data driven clusters derived from resting state functional connectivity: Findings from the EMBARC study. J Psychiatr Res. 2023 Feb;158:150-156. doi: 10.1016/j.jpsychires.2022.12.002. Epub 2022 Dec 27.
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DERIVED
Jha MK, Schatzberg A, Minhajuddin A, Chin Fatt C, Mayes TL, Trivedi MH. Cross-Sectional Associations Among Symptoms of Pain, Irritability, and Depression and How These Symptoms Relate to Social Functioning and Quality of Life: Findings From the EMBARC and STRIDE Studies and the VitalSign6 Project. J Clin Psychiatry. 2021 Apr 13;82(3):20m13740. doi: 10.4088/JCP.20m13740.
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Jha MK, Fava M, Minhajuddin A, Chin Fatt C, Mischoulon D, Cusin C, Trivedi MH. Association of anger attacks with suicidal ideation in adults with major depressive disorder: Findings from the EMBARC study. Depress Anxiety. 2021 Jan;38(1):57-66. doi: 10.1002/da.23095. Epub 2020 Oct 10.
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Chin Fatt CR, Cooper C, Jha MK, Aslan S, Grannemann B, Kurian B, Greer TL, Fava M, Weissman M, McGrath PJ, Parsey RV, Etkin A, Phillips ML, Trivedi MH. Dorsolateral Prefrontal Cortex and Subcallosal Cingulate Connectivity Show Preferential Antidepressant Response in Major Depressive Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Jan;6(1):20-28. doi: 10.1016/j.bpsc.2020.06.019. Epub 2020 Jul 8.
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Jha MK, Minhajuddin A, Chin Fatt C, Trivedi MH. Improvements in irritability with sertraline versus placebo: Findings from the EMBARC study. J Affect Disord. 2020 Oct 1;275:44-47. doi: 10.1016/j.jad.2020.06.021. Epub 2020 Jun 26.
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Other Identifiers
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STU 092010-151
Identifier Type: -
Identifier Source: org_study_id