Exploring Biomarkers for Depression

NCT01424111 | Completed

• 1 other identifier: AMD-CS-0007
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Biomarkers; Depression; Major Depressive Disorder; Escitalopram

Outcome Measures

Primary Outcomes (1)

• Objective Biomarkers

  Objective biomarkers in voice, physiological, motor and brain imaging signals

  Participants will be followed for an expected average of 9 weeks of data collection.

Study Arms (2)

Treatment

Those receiving an open-label, 10-20 mg/day, flexible-dose of escitalopram. The treatment period is 8 weeks long.

Drug: Escitalopram

Healthy Control

Those not receiving treatment.

Other: Healthy Control

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro, Cipralex, Seroplex, Lexamil, Lexam

Treatment

Healthy Control OTHER

No Treatment

Healthy Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wyss Institute at Harvard University: lead
• Massachusetts General Hospital: collaborator
• Martinos Center for Biomedical Imaging: collaborator
• Massachusetts Institute of Technology: collaborator

Study Sites (1)

Depression Clinical and Research Program, MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 26, 2011
• Study Start: August 1, 2011
• Primary Completion: October 14, 2017
• Study Completion: October 14, 2017
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (1)