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

I

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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