NCT05598034 Evaluating tDCS Brain-stimulation in Depression Using MRI
| NCT ID | NCT05598034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2022-10-20 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2022-10-20 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients, physicians, and those who fund depression research are keenly interested in depression treatments that do not involve taking medications. One promising candidate treatment is transcranial direct current stimulation (tDCS), a low-cost technique that involves placing electrodes on specific scalp locations and using a 9-volt battery to cause a small amount of electricity to pass through parts of the brain. Depending on the direction of electrical flow, tDCS can make brain cells (neurons) more likely or less likely to generate their own electrical signals. When evaluated as a treatment, tDCS is typically done in daily sessions over a period of two weeks. One of the challenges of tDCS is to work out the best possible positioning of electrodes and direction of electricity flow to gradually cause lasting changes in brain activity in ways that might be expected to improve depression. To address this challenge, the investigators are using MRI to take pictures of the brain during tDCS. This data will help us better understand the short-term effects of tDCS in depression and help us learn how to customize future treatments to cause a lasting beneficial response. Patients with depression between the ages of 20-55 years are eligible to take part in this research. Potential participants will undergo: 1. An assessment to confirm eligibility. This will take place over a secure videoconference call lasting no more than 3 hours. 2. Two in-person study visits lasting 30 min and 2-1/2 hours respectively. In the first visit, the investigators will use the MRI to take a picture of the brain and head structure to determine appropriate locations for placing the tDCS electrodes at the start of the second visit. Following electrode placement, an MRI scan will be performed to take pictures of the brain during tDCS. Depending on the study arm, 1. Participants may receive 'active' or 'sham' tDCS. The 'sham' condition is identical to the 'active' tDCS in every way except that it involves minimal tDCS and is designed to help rule out effects unrelated to the administered tDCS electricity. 2. Participants may also be asked to perform a mental task during MRI.
Eligibility Criteria
Inclusion Criteria: 1. Age between 20 to 55 years, inclusive 2. Gender: all 3. Race/ethnicity: all races and ethnic groups 4. Capacity to provide informed consent 5. Hamilton Rating Scale for Depression score of ≥17 and \<24, with or without symptoms of anxiety. 6. Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic's (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention. 7. Work at UCLA or live within 1-hr driving distance of UCLA Exclusion Criteria: 1. Pregnancy 2. Non-English speaking (due to scales administered) 3. Substance Use Disorder within last 12 months 4. Neurological condition associated with brain abnormalities (e.g., traumatic brain injury; recent stroke, tumor) 5. Any contraindication to tDCS (e.g., skin disease or treatment causing irritation) 6. Any condition that would contraindicate scanning (metal implants, claustrophobia or a breathing or movement disorder) 7. Currently receiving any form of psychotherapy 8. Change in antidepressant medication within 6-weeks of starting the trial 9. Severe or treatment resistant depression - HAMD scores \> 24 and a history of a major depressive episode lasting \>2- years or failure to 2 or more antidepressant trials in the current index episode 10. Any neuromodulation therapy (e.g., ECT, rTMS, DBS, VNS or tDCS) within the last 3-months 11. Current or past (within the last 1-month) use of anticonvulsants, lithium, psychostimulant, dexamphetamine 12. Current use of decongestants or other medication previously shown to interfere with cortical excitability 13. Diagnosis: Schizophrenia Axis I disorder, or dementia of any type 14. Bipolar I disorder (due to possible risk of mania and because lithium and anticonvulsants are excluded). 15. On regular benzodiazepine medication that it is not clinically appropriate to discontinue for the 2-week duration of the trial 16. Depression related to serious medical illness (i.e., mood disorder due to general medical condition) 17. Actively suicidal as defined by a score of 4 on item 3 of HAMD
Contact & Investigator
Mayank A Jog, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05598034 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 55 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05598034 currently recruiting?
Yes, NCT05598034 is actively recruiting participants. Contact the research team at brainmapping.ucla@gmail.com for enrollment information.
Where is the NCT05598034 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05598034 clinical trial?
NCT05598034 is sponsored by University of California, Los Angeles. The principal investigator is Mayank A Jog, PhD at University of California, Los Angeles. The trial plans to enroll 144 participants.