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Device

Stimulation for Depression

N/A
Waitlist Available
Led By Sidney Kennedy, M.D.
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights

Study Summary

This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression (TRD). A total of 40 eligible participants will be randomized to four treatment sequences (10 participants per sequence). Each participant will be treated over a 6-month period with active or sham stimulation in which both the participants and the attending psychiatrists will be blinded to treatment allocation.

Eligible Conditions
  • Depression
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy: Changes in the Hamilton Depression Rating Scale-17
Secondary outcome measures
Showing SCG-DBS significantly increases health related quality of life compared to sham stimulation in patients with TRD
The incidence of all adverse events

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: StimulationActive Control1 Intervention
Libra Deep Brain Stimulation System is implanted and activated post implantation
Group II: No StimulationPlacebo Group1 Intervention
The Libra DBS System is implanted and not activated

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
404,456 Total Patients Enrolled
2 Trials studying Depression
134 Patients Enrolled for Depression
Sidney Kennedy, M.D.Principal InvestigatorToronto General Hospital
1 Previous Clinical Trials
86 Total Patients Enrolled
1 Trials studying Depression
86 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
2011. "A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01801319.
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~3 spots leftby Apr 2025
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