Neurofeedback In Treatment Resistant Depression

NCT04078438 | Terminated

• 1 other identifier: YUH-14-0389-B4
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators evaluate the effects of neurofeedback as an augmentation treatment on depressive symptoms and functional recovery in patients with treatment-resistant depression (TRD). TRD patients are assigned to the neurofeedback augmentation group and the medication-only (treatment as usual, TAU) group. The neurofeedback augmentation group underwent combined therapy comprising medication and 12-24 sessions of neurofeedback training for 12 weeks. To assess the serum levels of brain-derived neurotrophic factor (BDNF) in both groups, a pre- and post-treatment blood samples are obtained. Patients are evaluated using the Hamilton Depression Rating Scale (HAM-D), Beck Depression Inventory (BDI), Clinical Global Impression-Severity (CGI-S), 5-level version of European Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D-5L), and Sheehan Disability Scale (SDS) at baseline, and at the 1-, 4-, and 12-week.

Conditions

Depression; Neurofeedback

Keywords

Treatment-resistant depression; Neurofeedback; Functional recovery

Outcome Measures

Primary Outcomes (1)

• Changes in Hamilton Rating Scale for Depression [HAM-D] score at baselline and the 1-, 4-, and 12-week time points

  The HAM-D is an observer rating scale and 1 of the most widely used measures of depressive disorder. This scale composed of 17 items, and it has been used to assess the therapeutic effect as well as the severity of depression. Total score is 52, where higher scores indicating more severe depression. Hamilton considered Total score of 8-13 mild range, 14-18 moderate, 18-22 severe, and 23 or higher very severe.

  at baseline, and at the 1-, 4-, and 12-week time points.

Secondary Outcomes (7)

• Changes in Beck Depression Inventory- II (BDI-II) scores at baselline and the 1-, 4-, and 12-week time points

  at baseline, and at the 1-, 4-, and 12-week time points.

• Changes in Sheehan Disability Scale (SDS) score at baselline and the 1-, 4-, and 12-week time points

  at baseline, and at the 1-, 4-, and 12-week time points.

• Changes in Clinical Global Impression-Severity (CGI-S) at baselline and the 1-, 4-, and 12-week time points

  at baseline, and at the 1-, 4-, and 12-week time points.

• Comparisons of serum brain-derived neurotrophic factor (BDNF) level between baseline and the 12-week time point among groups

  at baseline, and 12-week time points.

• Type and number of adverse events

  through study completion, an average of 12 weeks

Study Arms (3)

neurofeedback augmentation group

EXPERIMENTAL

The neurofeedback augmentation group was asked to participate in 12 weeks of combined therapy of medication and 12-24 sessions of neurofeedback training. The neurofeedback protocol was determined considering the patient's main symptoms. Patients in the neurofeedback augmentation group received sensorimotor rhythm (SMR) beta or beta training for 30 minutes, and then alpha/theta (A/T) training for 30 minutes in each session.

Device: neurofeedback augmentation; Drug: treatment as usual

medication-only (treatment as usual, TAU) group

ACTIVE COMPARATOR

To reduce the impact of confounding factors, the medication-only (treatment as usual, TAU) group visited at the same schedule as neurofeedback augmentation group and received psychotherapy placebo sessions instead of neurofeedback training sessions. These sessions included psychological assessment and supportive psychotherapy. The medication-only (treatment as usual, TAU) group maintained the same medication use as that before the study.

Drug: treatment as usual; Other: psychotherapy placebo sessions

healthy controls

NO INTERVENTION

The healthy controls provided blood samples using the same procedure at baseline only.

Interventions

neurofeedback augmentation DEVICE

Neurofeedback training was performed using a Neurocybernetics EEG Biofeedback system (Neurocybernetics Inc., Encino, CA, USA). The neurofeedback protocol was determined by the neurofeedback team, which included 3 psychiatrists, in consideration of the patient's main symptoms. The neurofeedback augmentation group was asked to participate in 12 weeks of combined therapy of medication and 12-24 sessions of neurofeedback training. Patients in the neurofeedback augmentation group received sensorimotor rhythm (SMR) beta or beta training for 30 minutes, and then alpha/theta (A/T) training for 30 minutes in each session. To reduce the impact of confounding factors, the medication-only (treatment as usual, TAU) group visited at the same schedule as neurofeedback augmentation group and received psychotherapy placebo sessions. The medication-only (treatment as usual, TAU) group maintained the same medication use as that before the study.

neurofeedback augmentation group

treatment as usual DRUG

The neurofeedback augmentation group and the medication-only group maintained the same medication use as that before the study.

Also known as: medication

medication-only (treatment as usual, TAU) group; neurofeedback augmentation group

psychotherapy placebo sessions OTHER

To reduce the impact of confounding factors, the medication-only (treatment as usual, TAU) group visited at the same schedule as neurofeedback augmentation group and received psychotherapy placebo sessions instead of neurofeedback training sessions. These sessions included psychological assessment and supportive psychotherapy.

medication-only (treatment as usual, TAU) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagosis with MDD according to the DSM-IV-TR criteria for MDD, and especially treatment-resistant MDD (Hamilton Rating Scale for Depression \[HAM-D\] score ⩾14) despite adequate antidepressant therapy)

You may not qualify if:

• Psychosis
• Bipolar disorder
• Brain injury
• Clinically diagnosed neurological disorder
• Convulsive disorder
• Pregnancy

Sponsors & Collaborators

• Yeungnam University Hospital: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Related Publications (1)

• Lee YJ, Lee GW, Seo WS, Koo BH, Kim HG, Cheon EJ. Neurofeedback Treatment on Depressive Symptoms and Functional Recovery in Treatment-Resistant Patients with Major Depressive Disorder: an Open-Label Pilot Study. J Korean Med Sci. 2019 Nov 4;34(42):e287. doi: 10.3346/jkms.2019.34.e287.

  PMID: 31674161 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant

Interventions

Therapeutics; Dosage Forms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Eun-Jin Cheon, M.D., Ph.D

  Yeungnam University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 6, 2019
• Study Start: June 27, 2014
• Primary Completion: December 27, 2019
• Study Completion: February 8, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

KR (1)