Functional Brain Imaging Study of Response to Repetitive TMS (rTMS) Treatment of Major Depression

Status unconfirmed

Conditions studied: Major Depression

In brief

The investigators plan to use optical brain imaging technology to observe patients with current major depression before, during, and after repetitive Transcranial Magnetic Stimulation (rTMS) clinical treatment. Clinical treatment involves 20-30 rTMS sessions over the course of 4-6 weeks. Our primary hypotheses are as follows: 1. Primary Hypothesis: In patients with a positive response to rTMS, the investigators will observe an increase in the strength of connectivity as measured by fMRI among brain regions in the cognitive control network after 4 weeks of treatment. 2. Secondary Hypothesis: Brain activation measured by functional Near-Infrared Spectroscopy(fNIRS) in the dorso-lateral prefrontal cortex (DLPFC) during rTMS will increase as the number of treatments increase. Detection of this increase in brain activity at the beginning of the treatment help researchers and physicians assess treatment response.

Key facts

Study ID

NCT01768052

Run by

Mclean Hospital

People needed

40

Starts

2013-06-01

Expected to finish

2016-01-01

Last updated by the study team

2015-05-04

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be 21-45 years old.
• Current episode of depression must be of a duration of three years or less
• Participants must have a score of 18 or more on the 24-item version of the HDRS
• Participants must have failed at least one adequate trial of antidepressant medication in this or the most recent depressive episode, but not more than four medications.
• Alternatively, they can have shown an inability to tolerate four such agents due to side effects
• Participants may be medicated or un-medicated.
• Medication adjustments may be introduced during the course of the TMS treatment by his or her primary psychiatrist in consultation with Dr. Morales. At the discretion of the PI and study physician, subjects that begin taking or undergo a change in certain medications known to influence mood or vascular circulation may be excluded from the study analysis. Exclusion from the analysis will not affect their clinical treatment.
• Women entering this study must complete a urine pregnancy screen prior to fMRI scanning unless they are post-menopausal, clinically defined as no menses in greater than 12 months or having had surgical removal of the ovaries.
• Subjects must be in inpatient/outpatient treatment with a prescribing mental health clinician.
• Subjects will meet DSM-IV criteria for or Major Depressive Disorder and be currently depressed.
• Subject must have a HAM-D score ≥ 18 and a MADRS score > 18.
• At the discretion of a study psychiatrist or PI, a HAM-D/MADRS score of less than 18 may be accepted if enough depressive symptoms are present and the subject meets DSM criteria for depression.
• Capable of giving informed consent, including compliance with restrictions and restrictions listed on consent form.

You may not qualify if…

• Currently pregnant or planning to be pregnant during the course of the study, as verified by positive pregnancy test on fMRI scan days, or childbearing potential and not using adequate contraception. Adequate contraception includes birth control pills, birth control shots, or a non-metallic, MRI-compatible intrauterine device (IUD). Those not of childbearing potential include post-menopausal for more than 6 months, surgically sterilized, or male participants.
• Active neurological diseases, history of seizure disorder, dementias, or acute medically unstable or unmanaged physical illnesses.
• Failed more than four antidepressant medications in this or the most recent depressive episode
• Any contraindication to MRI scanning as assessed by pre-screening MRI questionnaire (including, but not limited to, the presence of ferrous implant, pacemaker, etc…).
• History of clinically significant claustrophobia.
• Weight greater than 250 pounds (>113.4kg).
• Evidence of drug use, nicotine use, alcohol use, or caffeine use by participant and/or clinical observation on the fMRI scanning days.
• Any clinically significant brain structural abnormalities per patient's medical history or per report generated from the clinical structural scan performed during baseline scanning. Per the discretion of the study physician and the principal investigator, subjects who meet this exclusion criterion may be included in the research study and excluded from the study analysis.
• Patients who, in the investigators' judgment, will not likely be able to comply with the study protocol.

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States (enrolling)
• McLean Imaging Center/McLean TMS Service — Belmont, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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