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

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ClinicalTrials.gov Identifier: NCT02016456
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Nottinghamshire Healthcare NHS Trust
Information provided by (Responsible Party):
Sudheer Lankappa, Institute of Mental Health Nottingham

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Depression Device: Theta-Burst Stimulation Device: High frequency stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of Transcranial Magnetic Stimulation in the National Health Service
Study Start Date : October 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Theta-Burst Stimulation
Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)
 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.
Active Comparator: High Frequency stimulation
High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.
 Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Mean change in Beck Depression Inventory scores [ Time Frame: 4 weeks ]

Other Outcome Measures:
  1. Change in processing speed (using modified digit-symbol test) scores [ Time Frame: 4 weeks and 3 months ]
  2. Change in Clinical Global Impression scores [ Time Frame: 4 weeks and 3 months ]
  3. Change in Social and Occupational Functioning Assessment scores [ Time Frame: 4 weeks and 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016456


Locations
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United Kingdom
Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust
Nottingham, England, United Kingdom, NG2 7UH
Sponsors and Collaborators
Institute of Mental Health Nottingham
Nottinghamshire Healthcare NHS Trust
Investigators
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Principal Investigator: Sudheer Lankappa, MRCPsych Nottinghamshire Healthcare NHS Trust
More Information
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Additional Information:

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Responsible Party: Sudheer Lankappa, Consultant Psychiatrist, Institute of Mental Health Nottingham
ClinicalTrials.gov Identifier: NCT02016456    
Other Study ID Numbers: AMH/021213
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Keywords provided by Sudheer Lankappa, Institute of Mental Health Nottingham:
Transcranial Magnetic Stimulation
Neuronavigation
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders