A randomized controlled trial into the efficacy of neurofeedback for treatment of major depressive disorder

A randomized controlled trial into the efficacy of neurofeedback for treatment of major depressive disorder - Neurofeedback for depression

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41680

Enrollment

Registered

2014-08-12

Start date

2014-11-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression major depressive disorder

Interventions

After signing informed consent, participants will be invited to the neurofeedback laboratory of the school for Mental Health and Neuroscience (MheNS). This laboratory is a facility that meets the re

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Primary axis-1 disorder of Major Depressive Disorder fulfilling DSM-IV-TR criteria. • Written informed consent.

Exclusion criteria

Exclusion criteria: • History of brain trauma (commotio or contusio cerebra) or CVA • Current use of antipsychotics, moodstabilizers or benzodiazepines. Current use of antidepressants is permitted if this medication is not changed within a period of 6 weeks prior to participation in the study. Additionally, no changes in antidepressant medication are allowed during active participation in the study. • Chronic depression (> two years duration). • Dysthymia as a primary axis-1 diagnosis • Bipolar disorder or schizophrenia as a primary axis-1 diagnosis • Severe suicidality (HDRS item # 3 with a score >2) or severe depression symptomatology (HDRS score > 25). • Pregnancy. • Age 7 units.

Design outcomes

Primary

Measure	Time frame
Main outcome measures are the Quick Inventory of Depressive Symptoms (QIDS-SR), the Hamilton Depression Rating Scale (HDRS), the Remission from Depression Questionnaire (RDQ) and change in AA between frontal cortical regions. • The QIDS-SR is a 16-item self-rating scale to assess symptom severity of MDD and will be administered prior to each NF session (3 times a week). • The HDRS is a 17-item clinician-rated scale for estimating severity of depression during the past week. It will be administered once a week by a trained research assistant during the 6-week study period. • The RDQ is a 41-item self-rating scale that measures symptomatic and functional remission from depression. It will be administrated once a week during the 6-week study period. • AA in frontal regions (F3-F4) will be calculated as described in the intervention paragraph above. Based on results from our studies in healthy volunteers and depressed participants, no changes in AA in the sham-condition can be expected as opposed to significant decreases in AA in the active condition.	—

Measure

Time frame

Main outcome measures are the Quick Inventory of Depressive Symptoms (QIDS-SR), the Hamilton Depression Rating Scale (HDRS), the Remission from Depression Questionnaire (RDQ) and change in AA between frontal cortical regions. • The QIDS-SR is a 16-item self-rating scale to assess symptom severity of MDD and will be administered prior to each NF session (3 times a week). • The HDRS is a 17-item clinician-rated scale for estimating severity of depression during the past week. It will be administered once a week by a trained research assistant during the 6-week study period. • The RDQ is a 41-item self-rating scale that measures symptomatic and functional remission from depression. It will be administrated once a week during the 6-week study period. • AA in frontal regions (F3-F4) will be calculated as described in the intervention paragraph above. Based on results from our studies in healthy volunteers and depressed participants, no changes in AA in the sham-condition can be expected as opposed to significant decreases in AA in the active condition.

—

Secondary

Measure	Time frame
• The State and Trait Anxiety Inventory (STAI). This instrument measures state and trait anxiety symptomatology. • RAND-36. Based on 36 items, this instrument measures the general health on several dimensions. • Age, gender, duration of current depressed episode, marital status, educational level.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)