Brain Stimulation + Psychotherapy for Depression
(CARED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining brain stimulation and therapy can benefit individuals with depression unresponsive to typical treatments. Participants will receive Intermittent Theta Burst Stimulation (iTBS) alongside therapy and either an active or placebo version of another brain stimulation type. It targets individuals diagnosed with Major Depressive Disorder who experience at least mild to moderate symptoms and have not seen significant improvements with antidepressants. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for depression.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot have started any new psychotropic medication or changed doses in the 6 weeks before screening.
What prior data suggests that this combination of brain stimulation and psychotherapy is safe for treating depression?
Previous studies have shown that Intermittent Theta Burst Stimulation (iTBS) is safe and well-tolerated for treating depression. Research indicates that it may cause mild side effects like headaches or scalp discomfort, but these are usually temporary and not serious. The FDA has already approved iTBS for use in depression, supporting its safety.
For Transcranial Alternating Current Stimulation (tACS), studies show it is generally safe with no serious side effects reported. Some people might experience mild issues like skin irritation, but these are rare. Overall, tACS is considered a safe option for treating depression.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for depression because they combine brain stimulation with psychotherapy in a novel way. Unlike standard treatments like antidepressant medications or traditional talk therapy, Intermittent Theta Burst Stimulation (iTBS) and transcranial alternating current stimulation (tACS) directly target brain activity. iTBS uses rapid bursts of magnetic pulses to stimulate specific brain areas, potentially offering faster mood improvement. The active tACS, on the other hand, delivers gentle electrical currents to modulate brain wave patterns, which is a unique approach compared to typical treatments. This combination aims to enhance the effectiveness of psychotherapy, making this approach particularly promising for tackling depression.
What evidence suggests that this trial's treatments could be effective for Major Depressive Disorder?
Research has shown that Intermittent Theta Burst Stimulation (iTBS), which participants in this trial will receive, can significantly improve symptoms in people with depression. Studies have found that iTBS leads to a high rate of improvement, with one study noting a 69.2% improvement in symptoms four weeks after treatment. Additionally, about 30% of patients experienced remission, meaning their symptoms were greatly reduced.
In this trial, some participants will receive active Transcranial Alternating Current Stimulation (tACS) alongside psychotherapy and iTBS. Research indicates that tACS can effectively lessen depressive symptoms. One study reported a significant drop in depression severity, with some patients achieving up to 80% remission. This suggests that tACS, especially when combined with therapy, could be a promising way to treat depression.35678Who Is on the Research Team?
Flavio Frohlich, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with major depressive disorder who have not improved with at least one antidepressant. Participants must have mild to moderate symptoms, low suicide risk, be able to give informed consent, and agree to use contraception if needed.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Session Intervention
Participants receive psychotherapy, iTBS, and either active or sham tACS in a single session
Follow-up 1
Participants are monitored for symptom reduction and safety 2 weeks after the intervention
Follow-up 2
Participants are monitored for the longevity of intervention effectiveness 3 months after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Theta Burst Stimulation (iTBS)
- Psychotherapy
- Sham (Placebo) Transcranial Alternating Current Stimulation (tACS)
Trial Overview
The study tests a single session combining psychotherapy and non-invasive brain stimulation (iTBS) along with either real or placebo tACS in people with depression that hasn't responded well to standard treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive psychotherapy, active iTBS, and active tACS in which alpha-theta tACS will be delivered with a 20 second ramp up and ramp down, at the beginning and end of stimulation followed by 2 mA between the stimulation sites. The stimulation amplitude delivered is standard for tACS studies conducted in the Frohlich Lab
Participants will receive psychotherapy, active iTBS, and sham tACS in which alpha-theta tACS is delivered for 40 seconds before ramping down to close to 0 mA of current. The sham is designed to mimic the sensation of receiving Alpha and Theta tACS without delivering a sufficient dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Foundation of Hope, North Carolina
Collaborator
Citations
Intermittent Theta Burst Stimulation for Major Depressive ...
The most common outcomes reported were reductions in the severity of depressive and anxiety symptoms, improvements in emotional regulation, and ...
Pilot study on the intensity-response of Intermittent theta-burst ...
Results: The response rate was 40% for iTBS75 and 37.5% for iTBS120, while the remission rate was 20% for iTBS75 and 25% for iTBS120. There was an improvement ...
NCT07033780 | Theta-Burst Stimulation to Treat Depression
It has been demonstrated to induce sustained plasticity in the DLPFC and the motor cortex. Studies have shown that iTBS is equally effective as ...
Efficacy study of intermittent theta burst stimulation(iTBS) in ...
The current study suggests that two days of active iTBS to the DLPFC region can rapidly, safely, and effectively improve depressive symptoms in adolescents ...
Efficacy and safety of intermittent theta-burst stimulation ... - PMC
A recent network meta-analysis (24) showed a significant superiority of active over sham iTBS in improving depressive symptoms in depression, ...
Efficacy and Safety of Accelerated Intermittent Theta Burst ...
The a-iTBS group showed significantly greater improvements in anxiety and self-reported depression than the sham group at all time points (all p ...
Accelerated Intermittent Theta Burst Stimulation for ...
This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.
Efficacy and safety of intermittent theta burst stimulation ...
The objective of this systematic review was to compare the safety and efficacy of iTBS and high-frequency (≥ 5 Hz) rTMS (HF-rTMS) for patients with treatment- ...
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