Neurofeedback as a Treatment Tool for Depression (NFD)

This study is currently recruiting participants.
Verified February 2014 by Cardiff University
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: February 4, 2014
Last verified: February 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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Primary Completion Date: February 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544205

Contacts
Contact: David Linden, Professor +442920688320 LindenD@cf.ac.uk
Contact: Moses Sokunbi, Dr. +442920870716 SokunbiMO@cf.ac.uk

Locations
United Kingdom
CUBRIC Recruiting
Cardiff, Wales, United Kingdom, CF103AT
Contact: David Linden, Professor    +442920688320    LindenD@cf.ac.uk   
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: February 4, 2014
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on April 14, 2014