Exploring Biomarkers for Depression
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Exploring Biomarkers for Depression|
- Objective Biomarkers [ Time Frame: Participants will be followed for an expected average of 9 weeks of data collection. ] [ Designated as safety issue: No ]Objective biomarkers in voice, physiological, motor and brain imaging signals
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Those receiving an open-label, 10-20 mg/day, flexible-dose of escitalopram. The treatment period is 8 weeks long.
An open-label, 10-20 mg/day, flexible-dose of escitalopram will be administered to all subjects included in this study in the form of tablets. The treatment period is 8 weeks long.
Those not receiving treatment.
Other: Healthy Control
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424111
|United States, Massachusetts|
|Depression Clinical and Research Program, MGH|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Andrew Nierenberg, MD||DCRP, Massachusetts General Hospital|
|Principal Investigator:||Diana Young, Ph.D||Wyss Institute, Harvard University|
|Principal Investigator:||Tommi Raij, MD, Ph.D||Martinos Center, Massachusetts General Hospital|