TMS Treatment for Depression in the National Health Service (TDEP)

Institute of Mental Health Nottingham

Status: Completed

Conditions: Depression

Treatments: Device: Theta-Burst Stimulation; Device: High frequency stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02016456

AMH/021213

Details and patient eligibility

About

This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.

Enrollment: 29 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of depressive disorder (DSM-IV)
• Diagnosis of treatment resistance (at least stage 1 as defined by Thase & Rush, 1997 for depression)
• Female or male between 18 and 70 years

Exclusion criteria

• History of Bipolar disorder
• Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery
• Metal objects in and around body that cannot be removed
• Pregnancy
• Cardiac pacemaker or implanted medication pump
• Major unstable medical illness
• Change in prescribed medication in the 2 weeks preceding the start of TMS trial
• Current alcohol/stimulant dependence with propensity for toxic/withdrawal seizures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups

Theta-Burst Stimulation

Experimental group

Description:

Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)

Treatment:

Device: Theta-Burst Stimulation

High Frequency stimulation

Active Comparator group

Description:

High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.

Treatment:

Device: High frequency stimulation