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Pilot-study into the effectiveness of neurofeedback in the treatment of major depressive disorder (MDD).


- candidate number5156
- NTR NumberNTR1629
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2009
- Secondary IDsNL25291.068.08 / 08-2-115 MEC Universiteit Maastricht
- Public TitlePilot-study into the effectiveness of neurofeedback in the treatment of major depressive disorder (MDD).
- Scientific TitlePilot-study into the effectiveness of neurofeedback in the treatment of major depressive disorder.
- ACRONYMN/A
- hypothesisNeurofeedback is effective in the treatment of major depressive disorder.
- Healt Condition(s) or Problem(s) studiedDepression, Depressive Disorder
- Inclusion criteria1. MMD as a primary axis-1 diagnosis according to criteria of the DSM-IV-TR;
2. Informed consent.
- Exclusion criteria1. History of braintrauma (commotio or contusio cerebri);
2. Current use of antipsychotics, moodstabilizers, benzodiazepines. the use of antidepressants is permitted if type and dosage are not changed during participation in the study;
3. Chronic MDD (>2 years duration of current episode);
4. Dysthymia;
5. Bipolar disorder;
6. Lefthandedness;
7. Severe (HDRS-17 > 25) episode of MDD which indicates prompt effective treatment;
8. Pregnancy;
9. Other psychiatric disorders other than co-morbid anxiety and personality disorders.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-nov-2009
- Target number of participants10
- InterventionsNeurofeedback will be administered based by means of frontal alpha-asymmetry (FA) feedback. Baseline resting-EEG signal will be analyzed and individual thresholds will be used to provide real-time visual feedback in order to diminish FA. A maximum of 30 NF sessions will be delivered with a frequency of 3 sessions each week.
- Primary outcome1. Hamilton depression rating scale (17-item);
2. Baseline frontal alpha-activity in resting EEG.
- Secondary outcomeQuick Inventory Depression Scale- SelfRating (16 items).
- Timepoints1. Premeasure; diagnosis and assessment of clinical variables (like severity of MDD);
2. Measurement of MDD severity before every NF session;
3. Assessment of clinical variables (like severity of MDD) upon completion of the intervention.

1. Premeasure: 6 days ESM;
2. Postmeasure: after 8 weeks of mindfulness training/time control: 6 days ESM;
3. Follow-ups are planned, but were not yet submitted to ethical committee;
4. Follow-up at 6 months;
5. Follow-up at 12 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. F.P.M.L. Peeters
- CONTACT for SCIENTIFIC QUERIESProf. Dr. F.P.M.L. Peeters
- Sponsor/Initiator University Maastricht (UM), Department of Psychiatry and Neuropsychology
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM), Department of Psychiatry and Neuropsychology
- PublicationsN/A
- Brief summaryIt is claimed that neurofeedback (NF) is efficacious in the treatment of MDD. So far, no studies have systematically examined such claims. However, basic neurophysiological studies appear to support the premise of NF that depression is associated with frontal alpha-asymmetry in the resting EEG. Reduction of this FA is thought to be related to a decrease in depressive symptomatology. The aim of this pilot-study is to investigate the effectiveness of NF (delivered as a frontal asymmetry protocol) in MDD by (1) decreasing FA, and (2) reducing severity of depressive symptomatology. In case of positive results in this pilot-study a larger scale RCT will be conducted.
- Main changes (audit trail)
- RECORD14-jan-2009 - 9-sep-2009


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