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Device

Deep Brain Stimulation for Depression

N/A
Waitlist Available
Led By Patricio Riva Posse, MD
Research Sponsored by Emory University
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 baseline, week 24 post-intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a brain stimulator can help those with severe depression who haven't responded to other treatments. It will last ten years or until the device is FDA approved.

Who is the study for?
This trial is for adults with severe depression that hasn't improved after trying at least four different treatments, including medications and possibly ECT. They should have been depressed for at least two years or had more than four episodes of depression in their lifetime. Participants must be able to give consent and not be pregnant, abusing substances, or have other serious mental health conditions.
What is being tested?
The study is testing Deep Brain Stimulation (DBS) targeting a brain area called the subgenual cingulate (Cg25). It aims to see if DBS can safely improve symptoms in those with treatment-resistant major depression over a ten-year period or until the device gets FDA approval.
What are the potential side effects?
Potential side effects may include discomfort from surgery, headache, infection risk at the implant site, mood changes like mania or apathy, cognitive changes such as memory problems, and possible hardware-related complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24 post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Hamilton Depression Rating Scale-17 Score

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948
23%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Dyspepsia
5%
Back pain
5%
Skeletal injury
5%
Head injury
5%
Speech disorder
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Osteoarthritis
3%
Ingrowing nail
3%
Postoperative wound infection
3%
Diabetes mellitus
3%
Pain in extremity
3%
Spinal osteoarthritis
3%
Alcohol poisoning
3%
Intervertebral disc protrusion
3%
Hypoaesthesia
3%
Diplopia
3%
Contusion
3%
Productive cough
3%
Joint sprain
3%
Macular degeneration
3%
Fluid retention
3%
Device migration
3%
Skin laceration
3%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Respiratory depression
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain StimulationExperimental Treatment1 Intervention
Participants with treatment resistant depression will have a device implanted for deep brain stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~710

Find a Location

Who is running the clinical trial?

The Dana FoundationOTHER
17 Previous Clinical Trials
947 Total Patients Enrolled
5 Trials studying Depression
321 Patients Enrolled for Depression
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,881 Total Patients Enrolled
62 Trials studying Depression
9,563 Patients Enrolled for Depression
Patricio Riva Posse, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Depression
10 Patients Enrolled for Depression
~2 spots leftby Nov 2025
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