Abbott Laboratories Infinity™ implantable deep brain stimulation system for Major Depressive Disorder

University of California, Los Angeles, Los Angeles, CA
Major Depressive Disorder+1 More ConditionsAbbott Laboratories Infinity™ implantable deep brain stimulation system - Device
Eligibility
21 - 70
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Major Depressive Disorder
  • Deep Brain Stimulation Surgery

Treatment Effectiveness

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: 18 months

18 months
Change in Montgomery and Asberg Depression Rating Scale (MADRS) score.
Change in another related clinical assessment: CGI
Change in another related clinical assessment: CSSRS
Change in another related clinical assessment: HAM-A
Change in another related clinical assessment: HAMD-17
Change in another related clinical assessment: HLQ
Change in another related clinical assessment: ISI
Change in another related clinical assessment: LAPS
Change in another related clinical assessment: MoCA
Change in another related clinical assessment: PGI
Change in another related clinical assessment: PHQ-9
Change in another related clinical assessment: PSQI
Change in another related clinical assessment: QIDS-SR
Change in another related clinical assessment: QOL
Change in another related clinical assessment: SAFTEE-SI
Change in another related clinical assessment: SCID-II
Change in another related clinical assessment: SF-36
Change in another related clinical assessment: SHAPS
Change in another related clinical assessment: TEPS
Change in another related clinical assessment: YMRS

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Randomized Discontinuation Period: OFF then ON DBS
Device
Experimental Group · 1 Intervention: Abbott Laboratories Infinity™ implantable deep brain stimulation system · Intervention Types: Device
Randomized Discontinuation Period: ON then OFF DBS
Device
Experimental Group · 1 Intervention: Abbott Laboratories Infinity™ implantable deep brain stimulation system · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,442 Previous Clinical Trials
10,082,009 Total Patients Enrolled
Nader PouratianLead Sponsor
1 Previous Clinical Trials
Nader Pouratian, MD, PhDPrincipal Investigator - UT Southwestern Medical Center
Ronald Reagan UCLA Medical Center, Santa Monica-UCLA Medical Center
University Of California (Medical School)
University Of Va Medical Center (Residency)
2 Previous Clinical Trials
264 Total Patients Enrolled
Randall Espinoza, MD, MPHPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
45 Total Patients Enrolled

Eligibility Criteria

Age 21 - 70 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced depression symptoms for at least two years, or you have had multiple episodes of depression, including your current episode, that have lasted for more than 12 months.

Who else is applying?

What state do they live in?
Texas66.7%
California33.3%
How old are they?
65+100.0%
What site did they apply to?
University of California, Los Angeles50.0%
UT Southwestern Medical Center50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
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:
  1. University of California, Los Angeles: < 24 hours
  2. UT Southwestern Medical Center: < 48 hours
Typically responds via
Email50.0%
Phone Call50.0%

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

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