Neurofeedback as a Treatment Tool for Depression (NFD)

This study is currently recruiting participants.

Verified February 2012 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 28, 2012

Last verified: February 2012

History of Changes

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:

MedlinePlus related topics: Depression

U.S. FDA Resources

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:	March 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

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

Contacts

Contact: Isabelle Habes, MD	+442920870345	HabesI@cf.ac.uk
Contact: David Linden, Professor	+442920687064	LindenD@cf.ac.uk

Locations

United Kingdom
CUBRIC	Recruiting
Cardiff, Wales, United Kingdom, CF103AT
Contact: Isabelle Habes, MD 02920870345 HabesI@cf.ac.uk

Sponsors and Collaborators

Cardiff University

Medical Research Council

National Institute for Social Care and Health Research

More Information

Publications:

Johnston SJ, Boehm SG, Healy D, Goebel R, Linden DE. Neurofeedback: A promising tool for the self-regulation of emotion networks. Neuroimage. 2010 Jan 1;49(1):1066-72. Epub 2009 Jul 29.

Johnston S, Linden DE, Healy D, Goebel R, Habes I, Boehm SG. Upregulation of emotion areas through neurofeedback with a focus on positive mood. Cogn Affect Behav Neurosci. 2011 Mar;11(1):44-51.

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 28, 2012
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 June 18, 2013

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