TMS Treatment for Depression in the National Health Service

Depression Clinical Trial

— TDEP  

Official title:

An Evaluation of Transcranial Magnetic Stimulation in the National Health Service

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016456
• Other study ID #: AMH/021213
• Status: Completed
• Phase: N/A
• First received: December 15, 2013
• Last updated: August 31, 2017
• Start date: October 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Institute of Mental Health Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Theta-Burst Stimulation
At 80% motor threshold determined using single pulse stimuli. Depending on the hemisphere determined by connectivity analysis and neuronavigation in each individual, either continuous (left prefrontal) or intermittent (right prefrontal) train of pulses will be delivered.
• High frequency stimulation
Left prefrontal stimulation. 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses

Locations

Country	Name	City	State
United Kingdom	Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust	Nottingham	England

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Mental Health Nottingham	Nottinghamshire Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in processing speed (using modified digit-symbol test) scores		4 weeks and 3 months
Other	Change in Clinical Global Impression scores		4 weeks and 3 months
Other	Change in Social and Occupational Functioning Assessment scores		4 weeks and 3 months
Primary	Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score		4 weeks
Secondary	Mean change in Beck Depression Inventory scores		4 weeks

External Links

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