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Biomarkers of Response to Treatment With Frontal Cortex Stimulation for Anxious Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03999736
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Diego A. Pizzagalli, Mclean Hospital

Brief Summary:
This is an add-on study to an existing multimodal neuroimaging study in MDD by investigating the acute effects of DLPFC tDCS on threat vigilance in 24-44 patients with MDD, as part of an open-label treatment intervention study. Behavioral and neural measures of threat vigilance will be taken acutely and investigated as predictors of subsequent treatment response to a four-week, fourteen-session DLPFC tDCS intervention, using a novel home-tDCS protocol. The design takes advantage of an existing rich set of candidate baseline behavioral, neural and molecular measures from the existing neuroimaging study, which could be used to predict treatment response to tDCS and thereby, aid future patient selection for clinical trials.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Anxiety Device: transcranial direct current stimulation using a Soterix mini-CT device Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarkers of Response to Treatment With Frontal Cortex Stimulation for Anxious Depression
Estimated Study Start Date : November 3, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Treatment

14 sessions x 30 minutes of 2mA transcranial direct current stimulation to the dorsolateral prefrontal cortex.

10 x sessions over the course of the initial two weeks (e.g. 5 x per week with flexibility).

4 x sessions over the course of a two week maintenance treatment.

Device: transcranial direct current stimulation using a Soterix mini-CT device
TDCS is used to non-invasively stimulate the brain through the application of electrical currents to a small region of the scalp using a battery-powered stimulator (Soterix Medical 2018) with rubber electrodes and conductive material (saline-soaked sponges). Both electrodes are attached to the scalp with a band. The stimulation points will be located using the 10-20 system of electroencephalogram (EEG) electrode location (localization carried out using a bespoke head strap). The electrode size of the stimulator used in this study is large (25 cm2) and the current strength used is low (2 mA) resulting in very low current density (0.08 mA/cm2). This protocol applies no more than 30 minutes of stimulation in a single session, which is typical for experimental studies (Brunoni et al. 2015; Loo et al. 2017). TDCS is an investigational device and has proceeded with a non-significant risk designation in many past trials and not required an investigational device exemption from the FDA.
Other Name: tDCS

Primary Outcome Measures :
  1. Number of participants with a reduction in depressive symptoms of 50% or more [ Time Frame: 4 weeks after first stimulation session ]
    The Montgomery-Asberg Depression Rating Scale will be used as a measure of depressive symptoms.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, of any race or ethnic origin. Females should be in follicular phase of their menstrual cycle during the MRI scan.
  • Ages 18 to 28
  • Right-handed, with normal or corrected-to-normal vision and hearing
  • Fluent English speaker, capable of providing written informed consent
  • Must meet diagnostic criteria for current MDD as defined in the DSM-V
  • A QIDS-C score ≥ 12 and a Beck Depression Inventory-II (BDI-II) score ≥ 14 (Beck et al., 1996)

Exclusion Criteria:

  • No contraindications to transcranial direct current stimulation including but not limited to: history of seizures or epilepsy, history of migraine, certain kinds of implants
  • Participants with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment
  • Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device (IUD), s/p tubal ligation, or partner with vasectomy) or currently breastfeeding women
  • Failure to meet MRI safety requirements
  • Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
  • History of seizures or seizure disorder
  • History or current diagnosis of any of the following DSM-5 psychiatric illnesses: attention-deficit/hyperactivity disorder (ADHD), organic mental disorder, learning disabilities, autism or any other pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder (OCD), anorexia nervosa, somatoform disorders, severe borderline or antisocial personality disorder, mild alcohol or substance use disorder within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion); specific phobia, social anxiety disorder, panic disorder, and generalized anxiety disorder will be allowed only if secondary to MDD; a history of PTSD if secondary to MDD and in remission for < 2 years
  • Patients with mood congruent or mood incongruent psychotic features
  • Current use of other psychotropic drugs
  • Patients with a lifetime history of electroconvulsive therapy (ECT)
  • Evidence of sickle cell anemia, Raynaud's disease, ulcerative skin diseases, and hemophilia
  • Evidence of significant inconsistencies in self-report
  • History of significant head injury of concussion with loss of consciousness of two minutes or more, or head injury with lingering functional/psychological impact
  • Claustrophobia or severe anxiety that might impact participation in neuroimaging
  • Injury or movement disorder that may make it difficult to lie still in an MRI scanner
  • History of regular marijuana use (5-7x) per week before age 15
  • Recent use (within 3 weeks) of any medication that affects blood flow or blood pressure, or which is vasodilating/vasoconstricting
  • Illness currently receiving acute treatment (e.g., taking antibiotics)
  • Current infectious illness (either transient or chronic, such as Lyme disease)
  • Current episode of allergic reaction or asthma
  • History of chronic migraine (> 15 days in a month)
  • History or current diagnosis of dementia
  • History or family history of mania
  • History of repeated fainting

Information from the National Library of Medicine

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 identifier (NCT number): NCT03999736

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Contact: Maria A Ironside, DPhil 617 417 5065
Contact: Diego A Pizzagalli, PhD 617 855 4230

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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital

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Responsible Party: Diego A. Pizzagalli, Professor of Psychiatry, Mclean Hospital Identifier: NCT03999736     History of Changes
Other Study ID Numbers: 2019P000167
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diego A. Pizzagalli, Mclean Hospital:
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders