Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication

Hadassah Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Major Depression

Treatments: Device: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00460902

395/3.11.06(HMO)

Details and patient eligibility

About

Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.

Enrollment: 57 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed as suffering from treatment resistant major depression
• Right laterality

Exclusion criteria

• other major axis I diagnosis
• severe axis II diagnosis
• risk factors to convulsions
• history of drug abuse in the past year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Deep TMS stimulation

Experimental group

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

DTMS with positive cognitive-emotional provocation

Experimental group

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

DTMS with negative cognitive-emotional provocation

Experimental group

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)