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Clinical Trials/NCT02016456
NCT02016456
Completed
Not Applicable

An Evaluation of Transcranial Magnetic Stimulation in the National Health Service

Institute of Mental Health Nottingham1 site in 1 country29 target enrollmentOctober 2014
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ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Institute of Mental Health Nottingham
Enrollment
29
Locations
1
Primary Endpoint
Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institute of Mental Health Nottingham
Responsible Party
Principal Investigator
Principal Investigator

Sudheer Lankappa

Consultant Psychiatrist

Institute of Mental Health Nottingham

Eligibility 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

Outcomes

Primary Outcomes

Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score

Time Frame: 4 weeks

Secondary Outcomes

  • Mean change in Beck Depression Inventory scores(4 weeks)

Study Sites (1)

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