Depression Clinical Trial
Official title:
Neurofeedback Treatment on Depressive Symptoms and Functional Recovery in Treatment-resistant Patients With Major Depressive Disorder: an Open-label Pilot Study
Verified date | June 2020 |
Source | Yeungnam University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 70 |
Est. completion date | February 8, 2020 |
Est. primary completion date | December 27, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - Psychosis - Bipolar disorder - Brain injury - Clinically diagnosed neurological disorder - Convulsive disorder - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yeungnam University Hospital | Daegu |
Lead Sponsor | Collaborator |
---|---|
Yeungnam University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Changes in Beck Depression Inventory- II (BDI-II) scores at baselline and the 1-, 4-, and 12-week time points | The BDI is self-report scale designed to evaluate the presence and severity of depressive symptoms. It is consisted of 21 items including cognitive, emotional, motivative, and physical symptoms of depression. Each question is scored from 0 to 3 points, and the total score ranges from 0 to 63, indicating the higher the total scores, the more severe the depression. It is considered total score of 0-9 minimal range, 10-15 mild, 16-23 moderate, and 24-63 severe. | at baseline, and at the 1-, 4-, and 12-week time points. | |
Secondary | Changes in Sheehan Disability Scale (SDS) score at baselline and the 1-, 4-, and 12-week time points | The SDS is a self-report scale designed by Sheehan to assess the severity of functional impairment. This scale consists of 3 items, and each item is divided into 11 levels from 0 to 10 points. It is considered 0 point: none, 1-3 points: mild, 4-6 points: moderate, and 7-10 points: severe. Total score ranges from 0 to 30 and means that the higher the total scores, the more severe the functional impairment. | at baseline, and at the 1-, 4-, and 12-week time points. | |
Secondary | Changes in Clinical Global Impression-Severity (CGI-S) at baselline and the 1-, 4-, and 12-week time points | The CGI-S is a single-item scale composed of 7 levels ranging from maximum score of 7 to normal state of 1. This scale is a measure by which the evaluator comprehensively assesses the severity of mental illness regardless of diagnosis. | at baseline, and at the 1-, 4-, and 12-week time points. | |
Secondary | Comparisons of serum brain-derived neurotrophic factor (BDNF) level between baseline and the 12-week time point among groups | Brain-derived neurotrophic factor (BDNF) acts on certain neurons of the central nervous system and the peripheral nervous system. It helps support the survival of existing neurons and encourages the growth and differentiation of new neurons and synapses. Previous studies have suggested the presence of an etiological link between the development of depression and BDNF. | at baseline, and 12-week time points. | |
Secondary | Type and number of adverse events | adverse events | through study completion, an average of 12 weeks | |
Secondary | Changes in valuation of 5 level version of European Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D-5L) (converted tariff score) | The EQ-5D-5L was developed by the EuroQol Group, and is used to assess 5 dimensions: mobility, self care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is consisted of 5 levels, so total 3125 health states can be evaluated. The valuation of EQ-5D-5L (converted tariff score) is an index score calculated by applying weight to each of the 5 EQ-5D-5L questionnaires to provide a comprehensive summary of health-related quality of life. The resulting set of tariff is widely used to calculate preferences for EQ-5D-5L health states. As EQ-5D-5L is translated according to the culture and situation of each country, EQ-5D-5L tariffs may differ at each country. The index score is valued from 0 to 1, and the higher scores indicate the higher quality of life for the patients. In this study, EQ-5D-5L tariffs (index values) were calculated according to the [The EQ-5D-5L valuation study in Korea.]. | at baseline, and at the 1-, 4-, and 12-week time points. | |
Secondary | Changes in response and remission rate of Hamilton Rating Scale for Depression [HAM-D] score | Remission was defined as achieving a HAM-D score below 7, and response was defined as a 50% or greater reduction in HAM-D score from baseline. | at baseline, and at the 1-, 4-, and 12-week time points. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |