Exploring Biomarkers for Depression
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|ClinicalTrials.gov Identifier: NCT01424111|
Recruitment Status : Active, not recruiting
First Posted : August 26, 2011
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder||Drug: Escitalopram 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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Exploring Biomarkers for Depression|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
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
- Objective Biomarkers [ Time Frame: Participants will be followed for an expected average of 9 weeks of data collection. ]Objective biomarkers in voice, physiological, motor and brain imaging signals
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|