Status:
COMPLETED
Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 design...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
July 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT01407094
Start Date
July 29 2011
End Date
April 1 2016
Last Update
December 26 2018
Active Locations (4)
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1
Massachusetts General Hospital Boston
Boston, Massachusetts, United States, 02114
2
University of Michigan Ann Arbor
Ann Arbor, Michigan, United States, 48104
3
Columbia Univerisity New York City
New York, New York, United States, 10032
4
UT Southwestern Medical Center Dallas
Dallas, Texas, United States, 75309