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Deep Brain Stimulations for Depression

Phase 1

Depression | Unknown | Psychiatry |Medtronic plc.|Last Updated: Mar 28, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

Deep Brain Stimulations for Depression · 1 trial · 1 indication

Early Phase 1 1
NCT00555698Feasibility, Safety and Efficacy of Deep Brain Stimulation for DepressionDepression
COMPLETED8 Analytics
EARLY_PHASE1COMPLETED
Feasibility, Safety and Efficacy of Deep Brain Stimulation for Depression
Depression
NCT005556988
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Study Endpoints

Primary Endpoints

Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Depression Rating Scale (HDRS)
These scales are administered on each postoperative clinic visit. Visits occur monthly, except during the open continuation phase, when they occur every three months.

Secondary Endpoints

Inventory for Depressive Symptoms, Self-report (IDS-SR), Clinical Global Impressions (CGI), Patient Global Impressions (PGI), Global Assessment of Functioning (GAF), Social and Occupational Function Assessment Scale (SOFAS), Quality of LIfe Enjoyment and
These measures will be obtained at baseline, at the end of the initial chronic phase (typically after three months of chronic stimultion), at the end of the open continuation phase (at two years into the study).
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DBSEXPERIMENTALDBS

Interventions

NameTypeDescription
Deep Brain Stimulations for DepressionDEVICEDeep Brain Stimulations for Depression
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Major depression, severe, unipolar type, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity * 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 * Global Assessment of Function (GAF) score of 45 or less. * A re...

Countries:United States
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Frequently asked questions about Deep Brain Stimulations for Depression

What is Deep Brain Stimulation for Depression used for?

Deep Brain Stimulation for Depression is an investigational therapy being studied for the treatment of depression. It involves the use of a device to deliver electrical stimulation to specific areas of the brain. The therapy is currently in early-phase clinical development and is not yet approved for general use.

Who makes Deep Brain Stimulation for Depression?

Medtronic plc (NYSE: MDT) is developing Deep Brain Stimulation for Depression. The company is conducting clinical research to evaluate the feasibility, safety, and efficacy of this approach for treating depression.

What phase is Deep Brain Stimulation for Depression in?

Deep Brain Stimulation for Depression is in Phase 1 clinical development. A single early-phase trial has been completed, involving 8 participants with depression. The therapy remains investigational and has not been approved by regulatory authorities.

What clinical trials is Deep Brain Stimulation for Depression in?

Deep Brain Stimulation for Depression has one completed clinical trial, registered as NCT00555698, titled 'Feasibility, Safety and Efficacy of Deep Brain Stimulation for Depression.' This early-phase study enrolled 8 participants in the United States and was not randomized or blinded.

Is Deep Brain Stimulation for Depression FDA approved?

Deep Brain Stimulation for Depression is not FDA approved. It is an investigational therapy currently in Phase 1 clinical development. A single early-phase trial has been completed, but the therapy has not yet received regulatory approval for the treatment of depression.