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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  1. Men or women age 18-65;
  2. Written informed consent;
  3. Meet DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for current major depressive episode (MDE);
  4. Hamilton Rating Scale for Depression (HAM-D-17) baseline score ≥ 16.

Treatment Group Exclusion Criteria:

  1. Subjects whose first language is not English;
  2. In women, pregnancy, plans to conceive, or unwillingness to comply with birth control requirements;
  3. Subjects with a baseline Clinical Global Impressions-Severity score of 6 or 7;
  4. Subjects with suicidal ideation where outpatient treatment is determined unsafe by the clinician. These subjects will be immediately referred to appropriate clinical treatment;
  5. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
  6. History of seizure disorder;
  7. 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;
  8. Subjects with mood congruent or mood incongruent psychotic features;
  9. Clinical or laboratory evidence of hypothyroidism;
  10. Positive urine drug screen at evaluation visit;
  11. Electro Convulsive Therapy (ECT) during the last year;
  12. 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)
  13. History of intolerance to citalopram or escitalopram;
  14. 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).
  15. 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.
  16. Subjects of weight above 300 lbs. (limit for 1.5T Siemens Sonata whole body scanner used in MRI data acquisition);
  17. History of significant head trauma (unconsciousness for 10 minutes or longer);
  18. Surgical aneurysm clips;
  19. Cardiac pacemaker;
  20. Prosthetic heart valve;
  21. Use of a neurostimulator;
  22. Implanted pumps;
  23. Cochlear implants;
  24. Metal rods, plates, or screws in the body, or metal foil medical skin patches that cannot be removed;
  25. IUD;
  26. Previous head surgery;
  27. Hearing aid;
  28. Non-removable dentures, root canals, dental implants, bridges, and wires in the mouth;
  29. Currently breastfeeding;
  30. Meniere's Disease;
  31. Metal (shiny) tattoos or metal body jewelry that cannot be removed;
  32. Claustrophobia;
  33. Abnormal hearing;
  34. Glasses with vision correction greater than +/- 6 diopters.

Healthy/Control Group Inclusion Criteria:

  1. Men or Women, ages 18-65;
  2. Written informed consent;
  3. QIDS-SR score of < 8 at Screening Visit;
  4. Agrees to, and is eligible for, all biomarkers procedures (M/EEG, MRI, physiological recordings);

Healthy/Control Group Exclusion Criteria:

  1. Subjects whose first language is not English;
  2. 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;
  3. Meet DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for current major depressive episode (MDE);
  4. HAM-D-17 baseline score ≥ 8
  5. Any current Axis I or Axis II diagnoses;
  6. A woman who is pregnant or breastfeeding;
  7. Meeting DSM-IV criteria for substance dependence in the last 6 months, except for nicotine, or substance abuse in the last 2 months;
  8. Positive urine drug screen at evaluation visit;
  9. Any current history for an unstable general medical condition (GMC) that requires hospitalization or deemed by investigator to be clinically significant;
  10. 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:
  11. Subjects of weight above 300 lbs. (limit for 1.5T Siemens Sonata whole body scanner used in MRI data acquisition);
  12. History of significant head trauma (unconsciousness for 10 minutes or longer);
  13. Surgical aneurysm clips;
  14. Cardiac pacemaker;
  15. Prosthetic heart valve;
  16. Use of a neurostimulator;
  17. Implanted pumps;
  18. Cochlear implants;
  19. Metal rods, plates, or screws in the body, or metal foil medical skin patches that cannot be removed;
  20. IUD;
  21. Previous head surgery;
  22. Hearing aid;
  23. Non-removable dentures, root canals, dental implants, bridges, and wires in the mouth;
  24. Currently breastfeeding;
  25. Meniere's Disease;
  26. Metal (shiny) tattoos or metal body jewelry that cannot be removed;
  27. Claustrophobia;
  28. Abnormal hearing;
  29. 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

Other trials in United States

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.

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 groups in NCT01424111
Study groupRoleWhat they receive
TreatmentThose receiving an open-label, 10-20 mg/day, flexible-dose of escitalopram. The treatment period is 8 weeks long.
Receives: Drug: Escitalopram
Healthy ControlThose not receiving treatment.
Receives: Other: Healthy Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted26 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completion14 Oct 2017
  4. Study completion14 Oct 2017

Resources

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)
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

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.

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Exploring Biomarkers for Depression (NCT01424111) | AzTrials