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

NCT03999736 | Terminated Phase 1

• 1 other identifier: 2019P000167
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Anxiety

Keywords

tDCS; fMRI; fear; vigilance; biomarkers

Outcome Measures

Primary Outcomes (1)

• Number of participants with a reduction in depressive symptoms of 50% or more

  The Montgomery-Asberg Depression Rating Scale will be used as a measure of depressive symptoms.

  4 weeks after first stimulation session

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

transcranial direct current stimulation using a Soterix mini-CT device 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.

Also known as: tDCS

Treatment

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: Open-label

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: February 13, 2020
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)