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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24 post-intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Hamilton Depression Rating Scale-17 Score

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948

23%

Fall

15%

Depression

Hand fracture

Restless legs syndrome

Apathy

Head injury

Dyspepsia

Back pain

Speech disorder

Skeletal injury

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Pain in extremity

Diabetes mellitus

Intervertebral disc protrusion

Spinal osteoarthritis

Fluid retention

Postoperative wound infection

Osteoarthritis

Macular degeneration

Hypoaesthesia

Productive cough

Ingrowing nail

Respiratory depression

Parkinson's disease

Device migration

Akinesia

Syncope

Diplopia

Skin laceration

Joint sprain

Rib fracture

Drug withdrawal syndrome

Alcohol poisoning

Contusion

Cerebral microangiopathy

Dysarthria

Memory impairment

Movement disorder

Monarthritis

Neck pain

Adverse drug reaction

Cyst

Implant site haematoma

Oedema peripheral

Pyrexia

Pleural effusion

Nerve root lesion

Anxiety

Cough

Fibula fracture

Thermal burn

Sciatica

Anger

Bursitis

Cystitis

Helicobacter gastritis

Implant site infection

Localised infection

Pneumonia

Staphylococcal infection

Confusional state

Depressed mood

Hallucination, auditory

Impulse-control disorder

Insomnia

Panic attack

Rapid eye movements sleep abnormal

Bronchitis

Ear infection

Incision site infection

Arthralgia

Axillary pain

Folate deficiency

Hypertension

Hypotension

Thrombophlebitis

Laboratory test abnormal

Weight increased

Pericardial effusion

Seborrhoeic keratosis

Urinary incontinence

100%

80%

60%

40%

20%

Study treatment Arm

Deep Brain Stimulation

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

~700

Do I qualify?Apply below to find out

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

1,636 Previous Clinical Trials

2,560,536 Total Patients Enrolled

59 Trials studying Depression

8,979 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I qualify for this scientific research?

"This clinical trial is currently seeking 37 participants with Major Depressive Disorder (MDD) aged 18 to 70. To be eligible, potential volunteers must meet the following prerequisites: displaying a Current MDE of two years duration or greater OR having endured 4+ depressive episodes in their lifetime, an average HDRS-17 score of no less than 20 and not more than 30% lower than baseline screening HDRS-17 score at study commencement, assent to sign a written waiver allowing investigators access to information from the patient's psychiatrist, capability to provide informed consent in writing, identification as suffering from MDE secondary to either MDD or Bipolar"

Answered by AI

Are there still opportunities for enrollment in this research?

"The clinical trial mentioned is no longer actively recruiting, with its last update dated June 29th 2022. However, 1305 other medical studies are currently looking for participants on the same platform."

Answered by AI

Does the age cutoff for this research exclude octogenarians?

"All qualified applicants must be between 18 and 70 years of age to participate in this trial. Separately, there are 193 studies for those below the legal age limit as well as 975 trials aimed at elderly patients over 65."

Answered by AI