Exploring Biomarkers for Depression

Wyss Institute at Harvard University1 site in 1 country51 target enrollmentAugust 2011

ConditionsMajor Depressive Disorder

InterventionsEscitalopram Healthy Control

DrugsEscitalopram

Overview

Phase: Not Applicable
Intervention: Escitalopram
Conditions: Major Depressive Disorder
Sponsor: Wyss Institute at Harvard University
Enrollment: 51
Locations: 1
Primary Endpoint: Objective Biomarkers
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to explore objective biomarkers in voice, physiological, motor, and brain imaging signals that may one day be used to complement clinical evaluation and treatment of depression.

Detailed Description

The hypothesis for our work is that dynamical fluctuations of biological signals, such as, voice, video, pulse rate, oxygen saturation, skin temperature, skin conductivity, motor response, magnetoencephalography (MEG), and electroencephalography (EEG), are less complex during depressive than normal phases. There is a great need for objective biomarkers that may complement current clinical measures to help recognize depression, monitor its severity, and quantify the effect of interventions and recovery. Data will be collected from 20 adult participants seeking outpatient treatment for depression at the Depression and Clinical Research Program at Massachusetts General Hospital (MGH), each participating for a total of approximately 9 weeks. For correlation of findings, data will also be collected from 20 subjects who take part in the healthy/control group. The healthy/control group will participate in a more limited study visit schedule over the course of 9 weeks, and will not be given any treatment. During study visits, the investigators will conduct recordings of voice, video, pulse rate, oxygen saturation, body temperature, skin conductivity, and motor movement at the Department of Psychiatry at MGH. In addition, each subject may participate in MEG, EEG, and Magnetic Resonance Imaging (MRI) brain imaging sessions at the Athinoula A. Martinos Center for Biomedical Engineering. In order to collect relevant data and correlate findings with accepted clinical measures of depression severity and response to treatment, this study is conducted as a follow-up study in concert with a typical drug treatment protocol for Major Depressive Disorder (MDD). Specifically, our measurements will be made in conjunction with a standard of care drug treatment protocol using the antidepressant medication escitalopram, an FDA-approved selective serotonin re-uptake inhibitor (SSRI) commonly used to treat depression. The data will be collected over a period of approximately 9 weeks.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

October 14, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Wyss Institute at Harvard University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men or women age 18-65;
•Written informed consent;
•Meet DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for current major depressive episode (MDE);
•Hamilton Rating Scale for Depression (HAM-D-17) baseline score ≥
•Treatment Group

Exclusion Criteria

•Subjects whose first language is not English;
•In women, pregnancy, plans to conceive, or unwillingness to comply with birth control requirements;
•Subjects with a baseline Clinical Global Impressions-Severity score of 6 or 7;
•Subjects with suicidal ideation where outpatient treatment is determined unsafe by the clinician. These subjects will be immediately referred to appropriate clinical treatment;
•Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
•History of seizure disorder;
•History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months;
•Subjects with mood congruent or mood incongruent psychotic features;
•Clinical or laboratory evidence of hypothyroidism;
•Positive urine drug screen at evaluation visit;