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: August 19, 2015
Last verified: August 2015

February 23, 2012
August 19, 2015
March 2012
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01544205 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neurofeedback as a Treatment Tool for Depression
fMRI Based Neurofeedback as a Treatment Method for Depression

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Unipolar Depression
Other: fMRI-based neurofeedback
5 sessions lasting one hour each
  • Experimental: Emotion network up-regulation
    Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).
    Intervention: Other: fMRI-based neurofeedback
  • Active Comparator: Place processing network up-regulation
    Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to place and house pictures (as identified during a functional localiser scan).
    Intervention: Other: fMRI-based neurofeedback

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01544205
SPON927-11, G 1100629, HS/10/25, 11/WA/0106
Not Provided
David Linden, Cardiff University
Cardiff University
  • Medical Research Council
  • National Institute for Social Care and Health Research
Principal Investigator: David E Linden, MD Cardiff University
Cardiff University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP