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Neurofeedback as a Treatment Tool for Depression (NFD)

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
National Institute for Social Care and Health Research
Information provided by (Responsible Party):
David Linden, Cardiff University
ClinicalTrials.gov Identifier:
NCT01544205
First received: February 23, 2012
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Unipolar Depression
Other: fMRI-based neurofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: fMRI Based Neurofeedback as a Treatment Method for Depression

Further study details as provided by Cardiff University:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale (HDRS) score [ Time Frame: Before start trial, after 4 weeks (i.e. 4 sessions), after 2 months (i.e. 5 sessions) and at 5 months (follow-up) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Emotion network up-regulation Other: fMRI-based neurofeedback
5 sessions lasting one hour each
Active Comparator: Place processing network up-regulation Other: fMRI-based neurofeedback
5 sessions lasting one hour each

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • major depressive disorder (MDD) diagnosis
  • stable Selective Serotonin Reuptake Inhibitors (SSRI) dose medication

Exclusion Criteria:

  • Other physical or psychiatric disorders
  • Current substance abuse
  • Current psychotherapy or other specific intervention
  • Exclusion criteria applicable to MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544205

Locations
United Kingdom
CUBRIC
Cardiff, Wales, United Kingdom, CF103AT
Sponsors and Collaborators
Cardiff University
Medical Research Council
National Institute for Social Care and Health Research
  More Information

Publications:
Responsible Party: David Linden, Professor of Translational Neuroscience, Cardiff University
ClinicalTrials.gov Identifier: NCT01544205     History of Changes
Other Study ID Numbers: SPON927-11, G 1100629, HS/10/25, 11/WA/0106
Study First Received: February 23, 2012
Last Updated: September 25, 2014
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014