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Deep Brain Stimulation System

Phase 2

Depression | Unknown | Psychiatry |Medtronic plc.|Last Updated: Jul 24, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01069952Electrical Stimulation of the Internal Capsule for Intractable DepressionPHASE2 COMPLETED 5 — — Dec 1, 2002 -Jul 24, 20121 United States
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Study Endpoints
Primary Endpoints
Hamilton Depression Rating Scale (HDRS)
Administered at base line, every 1 to 5 days during the acute phase (2 months), monthly during the chronic phase, then every three months during the open continuation phase
Secondary Endpoints
Inventory for Depressive Symptoms, Self Report (IDS-SR)
Administered at base line, every 1 to 5 days during the acute phase (2 months), monthly during the chronic phase, then every three months during the open continuation phase
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active DBSEXPERIMENTALParticipants will receive deep brain stimulation.
Interventions
NameTypeDescription
Deep Brain Stimulation SystemDEVICEIn DBS, thin wires are used to carry electric current to the parts of the brain involved in depression symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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

Countries:United States
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