Neurofeedback as a Treatment Tool for Depression (NFD)
This study is currently recruiting participants.
Verified February 2012 by Cardiff University
Sponsor:
Cardiff University
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 23, 2012 | ||||||||
| Last Updated Date | February 28, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01544205 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Neurofeedback as a Treatment Tool for Depression | ||||||||
| Official Title ICMJE | fMRI Based Neurofeedback as a Treatment Method for Depression | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Unipolar Depression | ||||||||
| Intervention ICMJE | Other: fMRI-based neurofeedback
5 sessions lasting one hour each |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01544205 | ||||||||
| Other Study ID Numbers ICMJE | SPON927-11, G 1100629, HS/10/25, 11/WA/0106 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | David Linden, Cardiff University | ||||||||
| Study Sponsor ICMJE | Cardiff University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Cardiff University | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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