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Clinical Trials/NCT01544205
NCT01544205
Completed
Not Applicable

fMRI Based Neurofeedback as a Treatment Method for Depression

Cardiff University2 sites in 1 country43 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unipolar Depression
Sponsor
Cardiff University
Enrollment
43
Locations
2
Primary Endpoint
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of the study is to investigate whether neurofeedback delivered via functional magnetic resonance imaging signals can be used to train depressed patients to self-regulate emotion networks and whether this improves clinical symptoms.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
September 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Linden

Professor of Translational Neuroscience

Cardiff University

Eligibility Criteria

Inclusion Criteria

  • major depressive disorder (MDD) diagnosis
  • stable antidepressant dose medication

Exclusion Criteria

  • Other physical or psychiatric disorders
  • Current substance abuse
  • Current psychotherapy or other specific intervention
  • Exclusion criteria applicable to MRI

Outcomes

Primary Outcomes

Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)

Time Frame: Before start trial (baseline), after intervention (appr. 2 months)

Secondary Outcomes

  • Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at the end of intervention (after 5th session)(Baseline, end of intervention (appr. 2 months))
  • Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up(Baseline, 3-month follow-up)
  • Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up(Baseline, 3-month follow-up)
  • Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at the end of intervention (after 5th session)(Baseline, end of intervention (appr. 2 months))
  • Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session)(Baseline, end of intervention (appr. 2 months))
  • Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up(Baseline, 3-month follow-up)
  • Change from Baseline in the Quality of Life Scale (QOLS) at follow-up(Baseline, 3-month follow-up)
  • Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up(Baseline, 3-month follow-up)
  • Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session)(Baseline, end of intervention (appr. 2 months))

Study Sites (2)

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