intermittent theta burst stimulation for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA Depression Research and Clinic Program, Los Angeles, CA
Depression+3 More
intermittent theta burst stimulation - Device
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a form of transcranial magnetic stimulation can improve symptoms of depression.

See full description

Eligible Conditions

  • Depression
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether intermittent theta burst stimulation will improve 1 primary outcome and 1 secondary outcome in patients with Depression. Measurement will happen over the course of through study completion, an average of 10 days.

Day 10
Percent change in Hamilton Depression Scale
Percent. change in The Inventory of Depressive Symptomatology-Self Report

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

intravenous citalopram hydrochloride (CIT)
1 of 4
continuous Theta Burst Stimulation
1 of 4
intermittent Theta Burst Stimulation
1 of 4
Placebo infusion
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 30 total participants across 4 different treatment groups

This trial involves 4 different treatments. Intermittent Theta Burst Stimulation is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

continuous Theta Burst Stimulation
Device
10 sessions of treatment with iTBS to left or cTBS to right DLPFC TBS consists of three TMS pulses given at 50 Hz, with this triplet repeated at a frequency of 5 Hz (every 200 ms). 1800 pulses of cTBS will be delivered
intermittent Theta Burst Stimulation
Device
10 sessions of treatment with cTBS to right DLPFC TBS consists of three TMS pulses given at 50 Hz, with this triplet repeated at a frequency of 5 Hz (every 200 ms). iTBS paradigm of a 2 s train repeated every 10 seconds
Placebo infusion
Drug
Placebo comparator to active study drug
intravenous citalopram hydrochloride (CIT)
Drug
A single 40 mg dose of CIT diluted in 60 cc normal saline will be delivered intravenously under double-blind conditions via pump over a 40-minute period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intermittent theta burst stimulation
2012
N/A
~160
continuous theta burst stimulation
2011
N/A
~130

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 10 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 10 days for reporting.

Who is running the study

Principal Investigator
A. F. L.
Andrew F. Leuchter, Principal Investigator
University of California, Los Angeles

Closest Location

UCLA Depression Research and Clinic Program - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received 2 prior treatments for Depression or one of the other 3 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
21-55 years of age. MDD currently depressed subjects will meet DSM-V criteria for MDD based on the Mini-International Neuropsychiatric Interview (MINI) (http://www.medicaloutcomes.com/index/mini7fororganizations) with a 17-item Hamilton Depression Rating Scale (HamD17) (Hamilton, 1960) score > 17.
Subjects must have failed to enter remission with at least two prior antidepressant medications in the current episode (Vasavada et al., 2016)
Must have been free of any medications known to significantly affect brain function for at least ten days prior to enrollment (except fluoxetine, which will require a five-week washout).

Patient Q&A Section

What are the signs of depression?

"Most people report feeling unwell, especially emotionally, and they also report problems with personal and family function. It is crucial that GPs recognize the signs and symptoms of depression to enable timely diagnosis." - Anonymous Online Contributor

Unverified Answer

Can depression be cured?

"Patients with depression do not have a specific gene on which to rest. However, patients who have a stressful or traumatic past are at a greater risk of having symptoms in their lifetime. Furthermore, patients who have low socioeconomic status are at a higher risk." - Anonymous Online Contributor

Unverified Answer

What is depression?

"Depression is a mental disorder that can affect daily functioning. Depressed parents may have a difficult time coping with the depression. Depression usually starts with the child. Depression treatment may help the child learn strategies to help themselves and their parents through therapy and coping skills." - Anonymous Online Contributor

Unverified Answer

How many people get depression a year in the United States?

"There is a significant number of individuals who meet either the ICD-10 or DSM-IV criteria for major depressive disorder. However, it is unknown whether these individuals suffer significant psychosocial or functional impairment. Further research into these questions is warranted." - Anonymous Online Contributor

Unverified Answer

What are common treatments for depression?

"Antidepressants are often prescribed and self-medicated to treat depression. A significant number of depressed persons have co-morbid anxiety disorders such that specific antidepressants are more appropriate." - Anonymous Online Contributor

Unverified Answer

What causes depression?

"About 10% of men with depressed mood have depressive symptoms during their life; however, if they go untreated, about 80% of depressed men will develop major depression. Depression may be caused by stressful circumstances that are difficult to control. Depression can cause the depressed person to feel like a burden to other people on account of what he or she is already doing for them. Depression is also associated with marital problems and financial hardship and can cause suicidal thoughts, which can then trigger the onset of suicide or attempt. Depression can result in a person failing to take advantage of the right opportunity as well as not focusing on the future and having a lower standard of living." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for depression?

"Data from a recent study of our survey indicate that patients are not satisfied by many clinical trials and that patient participation in clinical trials should not be limited only to randomized controlled trials. Trials in which nonrandomized or not randomized patients are included appear to have a significant impact on the results." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of continuous theta burst stimulation?

"The data illustrate the relative safety of the use of TBS on most of the common side effects experienced with other forms of tDCS, specifically headaches, sleep disturbances and alterations in tremor. A prospective study with a larger sample size is required to further clarify the most commonly reported side effects, especially the subjective ones." - Anonymous Online Contributor

Unverified Answer

What is continuous theta burst stimulation?

"CTBS is a non-invasive method of inducing long lasting changes of cortico-limbic communication. The data support evidence that CTBS can induce persistent inhibition of a single motor cortex brain rhythm. In contrast, the results also suggest that alterations induced by CTBS are transient and restricted to certain rhythmic components of ipsilateral cortical oscillatory EEG." - Anonymous Online Contributor

Unverified Answer

Is continuous theta burst stimulation typically used in combination with any other treatments?

"In our studies we used anodal BTABS only for the treatment of depression and did not use it in combination with other treatments. This suggests that anodal BTABS used alone might be sufficient to treat depression." - Anonymous Online Contributor

Unverified Answer

Does continuous theta burst stimulation improve quality of life for those with depression?

"In this small sample, CTS was effective for improving depression and QOL. Further studies are needed to determine the effectiveness of CTS versus traditional antidepressant treatment in improving QOL, and to establish the optimal frequency of stimulation to maximize benefits over time." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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