Major Depressive DisorderNCT01424111
Exploring Biomarkers for Depression
An observational study of Major Depressive Disorder, run by Wyss Institute at Harvard University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 14 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seeking treatment for Major Depressive Disorder at the Depression Clinical and Research Program at Massachusetts General Hospital. This study also enrolls a limited number of healthy controls.
Treatment Group 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 ≥ 16.
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;
- Electro Convulsive Therapy (ECT) during the last year;
- Subjects who have failed to respond during the course of their current major depressive episode to a trial of escitalopram (at least 40mg/day for six weeks or more)
- History of intolerance to citalopram or escitalopram;
- Subjects requiring excluded medications including antidepressants, anorexics, antiarrhythmics, and other psychotropic agents (including lithium, benzodiazepine sedatives, other sedatives, and anti-seizure medications), beta-blockers (such as metoprolol or propranolol) ketoconazole, itraconazole, fluconazole, erythromycin, omeprazole, cimetidine, dehydroepiandrosterone (DHEA), entacapone, hydroxytryptophan (5-HTP), ginkgo, St. John's Wort (hypercium), naratriptan, rizatriptan, sibutramine, zolmitriptan and warfarin (Coumadin).
- Subjects who have failed two or more adequate antidepressant trials during the current Major Depressive Episode (MDE) If a subject is deemed eligible from the above criteria, there is additional exclusion criteria required to participate in Martinos Center study visits, listed below. Subjects meeting any of the below criteria will not be allowed to participate in visits to the Martinos Center.
- Subjects of weight above 300 lbs. (limit for 1.5T Siemens Sonata whole body scanner used in MRI data acquisition);
- History of significant head trauma (unconsciousness for 10 minutes or longer);
- Surgical aneurysm clips;
- Cardiac pacemaker;
- Prosthetic heart valve;
- Use of a neurostimulator;
- Implanted pumps;
- Cochlear implants;
- Metal rods, plates, or screws in the body, or metal foil medical skin patches that cannot be removed;
- IUD;
- Previous head surgery;
- Hearing aid;
- Non-removable dentures, root canals, dental implants, bridges, and wires in the mouth;
- Currently breastfeeding;
- Meniere's Disease;
- Metal (shiny) tattoos or metal body jewelry that cannot be removed;
- Claustrophobia;
- Abnormal hearing;
- Glasses with vision correction greater than +/- 6 diopters.
Healthy/Control Group Inclusion Criteria:
- Men or Women, ages 18-65;
- Written informed consent;
- QIDS-SR score of < 8 at Screening Visit;
- Agrees to, and is eligible for, all biomarkers procedures (M/EEG, MRI, physiological recordings);
Healthy/Control Group Exclusion Criteria:
- Subjects whose first language is not English;
- Current or lifetime history for major depressive disorder, psychotic depression bipolar (I, II, or NOS) disorder, schizoaffective disorder, schizophrenia, or other Axis I psychotic disorder;
- Meet DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for current major depressive episode (MDE);
- HAM-D-17 baseline score ≥ 8
- Any current Axis I or Axis II diagnoses;
- A woman who is pregnant or breastfeeding;
- Meeting DSM-IV criteria for substance dependence in the last 6 months, except for nicotine, or substance abuse in the last 2 months;
- Positive urine drug screen at evaluation visit;
- Any current history for an unstable general medical condition (GMC) that requires hospitalization or deemed by investigator to be clinically significant;
- Any current history for a moderate or severe acute or chronic medical condition that, based on the judgment of the PI or appropriate medical personnel would exclude the subject i.e. epilepsy, unstable hypothyroidism; If a subject is deemed eligible from the above criteria, there is additional exclusion criteria required to participate in Martinos Center study visits. Subjects meeting any of the below criteria will not be allowed to participate in visits to the Martinos Center:
- Subjects of weight above 300 lbs. (limit for 1.5T Siemens Sonata whole body scanner used in MRI data acquisition);
- History of significant head trauma (unconsciousness for 10 minutes or longer);
- Surgical aneurysm clips;
- Cardiac pacemaker;
- Prosthetic heart valve;
- Use of a neurostimulator;
- Implanted pumps;
- Cochlear implants;
- Metal rods, plates, or screws in the body, or metal foil medical skin patches that cannot be removed;
- IUD;
- Previous head surgery;
- Hearing aid;
- Non-removable dentures, root canals, dental implants, bridges, and wires in the mouth;
- Currently breastfeeding;
- Meniere's Disease;
- Metal (shiny) tattoos or metal body jewelry that cannot be removed;
- Claustrophobia;
- Abnormal hearing;
- Glasses with vision correction greater than +/- 6 diopters.
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Clinical and Research Program, MGH
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram, Healthy Control
- Keywords
- Biomarkers, Depression, Major Depressive Disorder, Escitalopram
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro, Cipralex, Seroplex, Lexamil
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.
Healthy ControlOther
No Treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Those receiving an open-label, 10-20 mg/day, flexible-dose of escitalopram. The treatment period is 8 weeks long. Receives: Drug: Escitalopram | |
| Healthy Control | Those not receiving treatment. Receives: Other: Healthy Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Biomarkers
Objective biomarkers in voice, physiological, motor and brain imaging signals
Measured: Participants will be followed for an expected average of 9 weeks of data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completion14 Oct 2017
- Study completion14 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyss Institute at Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Martinos Center for Biomedical Imaging, Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Andrew Nierenberg, MD, Principal investigator, DCRP, Massachusetts General HospitalDiana Young, Ph.D, Principal investigator, Wyss Institute, Harvard UniversityTommi Raij, MD, Ph.D, Principal investigator, Martinos Center, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424111
- Sponsor's protocol ID
- AMD-CS-0007
- Status last verified
- Apr 2018
- First submitted
- 19 Aug 2011
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Biomarkers for Depression
- ClinicalTrials.gov ID
- NCT01424111
- Acronym / sponsor ID
- AMD-CS-0007
- Conditions
- Major Depressive Disorder
- Keywords
- Biomarkers, Depression, Major Depressive Disorder, Escitalopram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Wyss Institute at Harvard UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Martinos Center for Biomedical Imaging, Massachusetts Institute of Technology
- Study start
- Aug 2011
- Primary completion
- 14 Oct 2017 (actual)
- Study completion
- 14 Oct 2017 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: EscitalopramThose receiving an open-label, 10-20 mg/day, flexible-dose of escitalopram. The treatment period is 8 weeks long. |
| Healthy Control | – | Other: Healthy ControlThose not receiving treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking treatment for Major Depressive Disorder at the Depression Clinical and Research Program at Massachusetts General Hospital. This study also enrolls a limited number of healthy controls.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Lexapro, Cipralex, Seroplex, LexamilAn 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. | Drug | Treatment |
| Healthy ControlNo Treatment | Other | Healthy Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Nierenberg, MD principal investigator
DCRP, Massachusetts General Hospital
Diana Young, Ph.D principal investigator
Wyss Institute, Harvard University
Tommi Raij, MD, Ph.D principal investigator
Martinos Center, Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Wyss Institute at Harvard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Biomarkers (time frame: Participants will be followed for an expected average of 9 weeks of data collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.