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Deep Brain Stimulation Surgery for Treatment Resistant Depression
Study Summary
This trial is investigating whether a surgical procedure called deep brain stimulation (DBS) is a safe and effective treatment for people with treatment resistant depression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am between 21 and 70 years old and not pregnant.I will keep taking my current antidepressant unless it's unsafe.I don't have any health conditions that would make surgery risky for me.My cognitive function is good, with a MoCA score above 25.I have had a bleeding stroke in the past.You should not have diathermy treatment during the study.You have experienced physical or sexual abuse during your childhood.I will keep taking my current antidepressant unless it's unsafe.Suicide Ideation Questionnaire-Revised (SIQ-R) ≥10
Hamilton Depression Rating Scale-17 item (HDRS17) severity indicates that a person has a major depressive episodeMy current major depressive episode has lasted over 24 months or I've had at least 2 episodes, including one longer than 12 months.I have tried at least four different depression treatments without success.My current major depressive episode has lasted 2 years or I've had at least 2 episodes, including one longer than a year.You have a medical condition or neurological issue that the surgeon believes may make you unsuitable for the study.My antidepressant medication has been the same for the last 30 days.I am between 21 and 70 years old and not pregnant.I have a history of seizures.Your symptoms of depression are severe, as measured by a rating scale called HDRS17, with a score of 20 or higher.You have struggled with alcohol or drug addiction in the past 6 months, except for nicotine (smoking).You have recently shown a strong desire to harm yourself, including making a plan or attempting suicide within the past year.I am at a higher risk of bleeding due to my health condition or medications.My depression symptoms are severe, scoring 27 or higher on the MADRS.I cannot or will not use birth control during the study.You have been diagnosed with a severe mental illness like schizophrenia or bipolar disorder in the past.I have tried at least four different depression treatments without success.You have a diagnosed personality disorder.I have been diagnosed with major depression for 10 years or less, starting in adulthood.My current major depressive episode has lasted 2 years or I've had at least 2 episodes, including one longer than a year.My depression symptoms are severe, scoring 27 or higher on the MADRS.
- Group 1: Randomized Discontinuation Period: OFF then ON DBS
- Group 2: Randomized Discontinuation Period: ON then OFF DBS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Am I eligible to participate in this clinical trial?
"This clinical study seeks to enroll 12 individuals, aged 21-70 years old, who suffer from persistent or recurrent depression and have been resistant to at least four prior treatment attempts. Furthermore, all applicants need a Hamilton Depression Rating Scale-17 item (HDRS17) score of 20 or more and Montgomery Asberg Rating Scale (MADRS) score of 27 or more one week pre-operatively. These participants must remain on stable antidepressant medication throughout the trial unless there are safety concerns."
Are individuals younger than 25 being considered for participation in the trial?
"This particular medical trial is looking for applicants aged between 21 to 70. However, there are 191 trials specifically targeting younger patients and 966 that prioritize those over the age of 65."
Is this experiment currently seeking participants?
"According to the clinicaltrials.gov platform, this medical trial is actively searching for volunteers; it was first introduced on October 28th 2022 and has been recently updated on October 31st of the same year."
What is the scope of this clinical research in terms of participants?
"Affirmative. According to clinicaltrials.gov, the trial was first made available on October 28th 2022 and has been actively recruiting since then. 12 participants are sought from 2 separate medical centres."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- University of California, Los Angeles: < 24 hours
- UT Southwestern Medical Center: < 48 hours
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