|- candidate number||5156|
|- NTR Number||NTR1629|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jan-2009|
|- Secondary IDs||NL25291.068.08 / 08-2-115 MEC Universiteit Maastricht|
|- Public Title||Pilot-study into the effectiveness of neurofeedback in the treatment of major depressive disorder (MDD).|
|- Scientific Title||Pilot-study into the effectiveness of neurofeedback in the treatment of major depressive disorder.|
|- hypothesis||Neurofeedback is effective in the treatment of major depressive disorder.|
|- Healt Condition(s) or Problem(s) studied||Depression, Depressive Disorder |
|- Inclusion criteria||1. MMD as a primary axis-1 diagnosis according to criteria of the DSM-IV-TR;|
2. Informed consent.
|- Exclusion criteria||1. 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);
5. Bipolar disorder;
7. Severe (HDRS-17 > 25) episode of MDD which indicates prompt effective treatment;
9. Other psychiatric disorders other than co-morbid anxiety and personality disorders.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2009|
|- planned closingdate||1-nov-2009|
|- Target number of participants||10|
|- Interventions||Neurofeedback 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 outcome||1. Hamilton depression rating scale (17-item);|
2. Baseline frontal alpha-activity in resting EEG.
|- Secondary outcome||Quick Inventory Depression Scale- SelfRating (16 items).|
|- Timepoints||1. 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 site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. F.P.M.L. Peeters|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. F.P.M.L. Peeters|
|- Sponsor/Initiator ||University Maastricht (UM), Department of Psychiatry and Neuropsychology|
(Source(s) of Monetary or Material Support)
|University Maastricht (UM), Department of Psychiatry and Neuropsychology|
|- Brief summary||It 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)|
|- RECORD||14-jan-2009 - 9-sep-2009|