Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Conditions
Keywords
Treatment, Treatment Resistant Depression, Major Depressive Disorder, MDD
Brief summary
The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours a day. Participants will self-administer treatment at home under direct remote supervision. Pre- and post- treatment neurophysiological biomarkers sessions will also be carried out. The study aims to examine changes in mood, brain activity, and related clinical outcomes before, during, and after treatment, with the goal to provide more information that can be used for future studies. PLEASE NOTE: THERE WILL BE 4 APPOINTMENTS THAT MUST OCCUR IN PERSON IN SAN DIEGO, CA.
Interventions
DEVICESpaced Transcranial Direct Current Stimulation (tDCS)
tDCS will be self-administered at home under the supervision of a trained clinical research coordinator using the Soterix Medical mini-CT device with remote monitoring via a secure videoconferencing platform (e.g., Microsoft Teams).The device is designed for safe, remote tDCS delivery. Participants will be treated using a stimulation at 2 mA, with a 30-second ramp-up and ramp-down phase.
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. People between the ages of 18 and 85 at the time of screening. 2. Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20. 3. Safe for TMS as measures by the TMS Adult Safety Screening (TASS). 4. Medical records confirming a history of failing to achieve clinical response to an adequate antidepressant trial as defined an Antidepressant Treatment History Form (ATHF) score ≥ 3 or ) or shown intolerance to at least two inadequate trials (score 1 or 2), without psychiatric illness due to a general medical condition. 5. Stable internet connection and a device compatible with Microsoft Teams.
Exclusion criteria
1. History of psychotic or bipolar disorder or depression with psychotic features; 2. Significant borderline personality disorder; 3. Significant comorbid obsessive-compulsive or post-traumatic stress: 4. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal; 5. Clinically significant suicidality disorder; 6. Chronic depression (defined as of over 5 years duration); 7. Pregnancy or lactation, lack of adequate birth control in women of childbearing age; 8. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms; 9. Unstable medical illness; 10. Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion); 11. History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response; 12. Require a benzodiazepine with a dose \> lorazepam 2 mg/day; 13. dermatological conditions contraindicating tDCS; 14. Non-correctable sensory impairments; 15. Inability to consent or participate as an outpatient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Recruitment) | From baseline clinical assessment prior to treatment to 12 weeks after last treatment. | Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number. |
| Feasibility (Retention) | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. | Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage. |
| Feasibility (Adherence) | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. | The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage. |
| Safety of at-home spaced tDCS | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. | Safety will be measured by the number of serious adverse events (SAEs) |
| Tolerability to spaced tDCS | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. | Tolerability will be measured by the number of adverse events (AEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from pre-treatment depressive symptomatology in post-treatment | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. | Changes in depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), which ranges from 0 to 60, with higher scores indicating more severe depression. A decrease in the MADRS score will be interpreted as an improvement in symptoms. |
| Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) via TMS-EMG | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. | TMS-EMG will be used to evaluate changes in SICI. |
| Biomarker Discovery: Intracortical Facilitation (ICF) via TMS-EMG | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. | TMS-EMG will be used to evaluate changes in intracortical facilitation |
| Biomarker Discovery: Cortical Silent Period (CSP) via Transcranial Magnetic Stimulation-Electromyography (TMS-EMG) | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. | TMS-EMG will be used to assess changes in the cortical silent period (CSP). Unit of Measurement: Duration (milliseconds). |
| Biomarker Discovery: TMS-Evoked Potential (TEP) Component Amplitudes via TMS-EEG | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. | TMS-EEG will be used to evaluate changes in TMS-evoked potential (TEP) component amplitudes. Unit of Measurement: Voltage (µV). |
| Biomarker Discovery: Resting-State Electroencephalography (rsEEG) | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. | rsEEG will be used to analyze changes in brain activity patterns at rest. Unit of Measurement: Frequency (Hz) |
Countries
United States
Contacts
CONTACTInterventional Psychiatry
Outcome results
None listed