Abbott Laboratories Infinity™ implantable deep brain stimulation system for Major Depressive Disorder
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.
- Major Depressive Disorder
- Deep Brain Stimulation Surgery
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 19 Secondary · Reporting Duration: 18 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Randomized Discontinuation Period: OFF then ON DBS
1 of 2
Randomized Discontinuation Period: ON then OFF DBS
1 of 2
Experimental Treatment
12 Total Participants · 2 Treatment Groups
Primary Treatment: Abbott Laboratories Infinity™ implantable deep brain stimulation system · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 21 - 70 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 66.7% |
| California | 33.3% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| University of California, Los Angeles | 50.0% |
| UT Southwestern Medical Center | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "treatment and money from study"
How many prior treatments have patients received?
| 3+ | 100.0% |
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- University of California, Los Angeles: < 24 hours
- UT Southwestern Medical Center: < 48 hours
Typically responds via
| 50.0% | |
| Phone Call | 50.0% |
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor