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

Stopped early · Phase 1/Phase 2

Conditions studied: Major Depressive Disorder, Anxiety

In brief

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.

Key facts

Study ID

NCT03999736

Run by

Mclean Hospital

People needed

1

Starts

2020-02-13

Expected to finish

2021-02-09

Last updated by the study team

2021-02-12

Who can join

Age: 18 and older, up to 28. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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