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The Role of Neuromodulation Technique In Depression Disorder

Primary Purpose

Depressive Disorder, Major

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rTMS
light therapy
ECT
MST
drug therapy
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-60;
  2. Meet the DSM-IV "major Depressive Episode" diagnostic criteria and are currently in the depressive episode (MDE) stage;
  3. The 17-item Hamilton Depression Scale (HAMD-17) score was > 17, and the HAMD-17 item 1 (depression) score was ≥2;
  4. Failure to respond adequately to at least one of the new antidepressants (including a HAMD-17 reduction rate of less than 50% and an intolerant drug side effect);
  5. Junior high school education or above, with sufficient audio-visual understanding of the research content, and signed the informed consent;
  6. If drug therapy is used at the same time, the medication regimen should remain unchanged at least 4 weeks before the follow-up group, and continue to remain unchanged during the neurological intervention in the acute phase;
  7. Right-handed.

Exclusion Criteria:

  1. Schizophrenia, or psychotic symptoms unrelated to depression, bipolar disorder, eating disorder, etc.;Personality disorders and mental retardation;Patients with depression caused by physical diseases;
  2. Suffering from the following serious diseases:History of brain injury or cerebrovascular accident, narrow-angle glaucoma, epilepsy, myocardial infarction, unstable angina pectoris, congestive heart failure, severe cirrhosis, acute and chronic renal failure, severe diabetes, aplastic anemia,Moderate to severe malnutrition and other serious neurological, heart, liver, kidney, endocrine, blood system and other physical diseases or diseases that may interfere with the study (abnormal index is more than 2 times the normal value);
  3. Patients with metal implants or electronic instruments (such as embedded intracranial electrodes, cochlea, medical pump, etc.), photosensitive dermatitis and other skin diseases or other contraindications in the body;
  4. Intracranial mass, cerebral infarction, increased intracranial pressure, or other active central nervous system disease, including epilepsy;Dementia, delirium, memory loss or other cognitive disorders;Brain trauma that increases the risk of seizures;
  5. Severe drug allergic reaction;
  6. Pregnant, lactating or planning to become pregnant;
  7. Substance abuse (excluding caffeine and nicotine) in the past 3 months;
  8. Received rTMS, tDCS, tACS, light therapy, ECT, MST, DBS therapy in the past 3 months;
  9. Serious suicide attempt (hamD-17 item 3 "suicide" score ≥3);
  10. Refuse to sign the informed consent.

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

drug therapy group

drug therapy combined with repetitive transcranial magnetic stimulation (rTMS) group

drug therapy combined with light therapy group

drug therapy combined with electroconvulsive therapy (ECT) group

drug therapy combined with magnetic seizure therapy (MST) group

Arm Description

Drug: drug therapy There is no restriction on the choice of therapeutic drugs.

Device: rTMS Stimulation will be performed for 20 working days once a day (4 weeks). Extend course to 30 sessions (6 weeks) in responders who have not achieved symptom remission. Frequency: 10Hz; Intensity: 110% RMT; Coil-type: F8; Sessions-pulse: 3000; Site: the left dorsolateral prefrontal cortex. Drug: drug therapy There is no restriction on the choice of therapeutic drugs.

Device: light therapy Active 10,000-lux fluorescent white light box for 30 min/d in the early morning for 6 weeks. Drug: drug therapy There is no restriction on the choice of therapeutic drugs.

Device: ECT The electrode placements are bifrontal (BF); the electrical intensity is 1.5 to 2.0 times the seizure threshold (ST); 3 times per week. Drug: drug therapy There is no restriction on the choice of therapeutic drugs.

Device: MST A coil placement at the vertex (i.e., Cz in 10-20 electroencephalogram [EEG] system) with a frequency of stimulation of 100 Hz, pulse width of 0.2 to 0.4 ms, and stimulation duration of 10 seconds; 2 times per week. Drug: drug therapy There is no restriction on the choice of therapeutic drugs.

Outcomes

Primary Outcome Measures

the change of the HAMD-17 score
the change of HAMD-17 score between baseline and after treatment.

Secondary Outcome Measures

remission rate
HAMD-17 total score ≤ 7 after treatment.
response rate
a reduction rate of HAMD-17 score ≥ 50% from baseline after treatment.

Full Information

First Posted
August 9, 2021
Last Updated
October 26, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05047159
Brief Title
The Role of Neuromodulation Technique In Depression Disorder
Official Title
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to explore the efficacy, safety and long-term effects of common and available non-invasive neuromodulation techniques in the treatment of depression, and to provide a data basis for the establishment of individualized treatment and efficacy prediction models. 450 patients will be enrolled and randomly assigned to five different treatments. Psychopathological assessment will be performed in both acute and maintenance phases of treatment with the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Patient Health Questionaire-9, the Sheehan Disability Scale, the Vascular Quality of Life-6 Questionnaire respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drug therapy group
Arm Type
Experimental
Arm Description
Drug: drug therapy There is no restriction on the choice of therapeutic drugs.
Arm Title
drug therapy combined with repetitive transcranial magnetic stimulation (rTMS) group
Arm Type
Experimental
Arm Description
Device: rTMS Stimulation will be performed for 20 working days once a day (4 weeks). Extend course to 30 sessions (6 weeks) in responders who have not achieved symptom remission. Frequency: 10Hz; Intensity: 110% RMT; Coil-type: F8; Sessions-pulse: 3000; Site: the left dorsolateral prefrontal cortex. Drug: drug therapy There is no restriction on the choice of therapeutic drugs.
Arm Title
drug therapy combined with light therapy group
Arm Type
Experimental
Arm Description
Device: light therapy Active 10,000-lux fluorescent white light box for 30 min/d in the early morning for 6 weeks. Drug: drug therapy There is no restriction on the choice of therapeutic drugs.
Arm Title
drug therapy combined with electroconvulsive therapy (ECT) group
Arm Type
Experimental
Arm Description
Device: ECT The electrode placements are bifrontal (BF); the electrical intensity is 1.5 to 2.0 times the seizure threshold (ST); 3 times per week. Drug: drug therapy There is no restriction on the choice of therapeutic drugs.
Arm Title
drug therapy combined with magnetic seizure therapy (MST) group
Arm Type
Experimental
Arm Description
Device: MST A coil placement at the vertex (i.e., Cz in 10-20 electroencephalogram [EEG] system) with a frequency of stimulation of 100 Hz, pulse width of 0.2 to 0.4 ms, and stimulation duration of 10 seconds; 2 times per week. Drug: drug therapy There is no restriction on the choice of therapeutic drugs.
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
Stimulation will be performed for 20 working days once a day (4 weeks). Extend course to 30 sessions (6 weeks) in responders who have not achieved symptom remission. Frequency: 10Hz; Intensity: 110% RMT; Coil-type: F8; Sessions-pulse: 3000; Site: the left dorsolateral prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
light therapy
Intervention Description
Active 10,000-lux fluorescent white light box for 30 min/d in the early morning for 6 weeks.
Intervention Type
Device
Intervention Name(s)
ECT
Intervention Description
The electrode placements are bifrontal (BF); the electrical intensity is 1.5 to 2.0 times the seizure threshold (ST); 3 times per week.
Intervention Type
Device
Intervention Name(s)
MST
Intervention Description
A coil placement at the vertex (i.e., Cz in 10-20 electroencephalogram [EEG] system) with a frequency of stimulation of 100 Hz, pulse width of 0.2 to 0.4 ms, and stimulation duration of 10 seconds; 2 times per week.
Intervention Type
Drug
Intervention Name(s)
drug therapy
Intervention Description
There is no restriction on the choice of therapeutic drugs.
Primary Outcome Measure Information:
Title
the change of the HAMD-17 score
Description
the change of HAMD-17 score between baseline and after treatment.
Time Frame
baseline, and 1, 2, 4, 8, 12, 24, 36, 48 weeks.
Secondary Outcome Measure Information:
Title
remission rate
Description
HAMD-17 total score ≤ 7 after treatment.
Time Frame
12, 24, 36, 48 weeks.
Title
response rate
Description
a reduction rate of HAMD-17 score ≥ 50% from baseline after treatment.
Time Frame
12, 24, 36, 48 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-60; Meet the DSM-IV "major Depressive Episode" diagnostic criteria and are currently in the depressive episode (MDE) stage; The 17-item Hamilton Depression Scale (HAMD-17) score was > 17, and the HAMD-17 item 1 (depression) score was ≥2; Failure to respond adequately to at least one of the new antidepressants (including a HAMD-17 reduction rate of less than 50% and an intolerant drug side effect); Junior high school education or above, with sufficient audio-visual understanding of the research content, and signed the informed consent; If drug therapy is used at the same time, the medication regimen should remain unchanged at least 4 weeks before the follow-up group, and continue to remain unchanged during the neurological intervention in the acute phase; Right-handed. Exclusion Criteria: Schizophrenia, or psychotic symptoms unrelated to depression, bipolar disorder, eating disorder, etc.;Personality disorders and mental retardation;Patients with depression caused by physical diseases; Suffering from the following serious diseases:History of brain injury or cerebrovascular accident, narrow-angle glaucoma, epilepsy, myocardial infarction, unstable angina pectoris, congestive heart failure, severe cirrhosis, acute and chronic renal failure, severe diabetes, aplastic anemia,Moderate to severe malnutrition and other serious neurological, heart, liver, kidney, endocrine, blood system and other physical diseases or diseases that may interfere with the study (abnormal index is more than 2 times the normal value); Patients with metal implants or electronic instruments (such as embedded intracranial electrodes, cochlea, medical pump, etc.), photosensitive dermatitis and other skin diseases or other contraindications in the body; Intracranial mass, cerebral infarction, increased intracranial pressure, or other active central nervous system disease, including epilepsy;Dementia, delirium, memory loss or other cognitive disorders;Brain trauma that increases the risk of seizures; Severe drug allergic reaction; Pregnant, lactating or planning to become pregnant; Substance abuse (excluding caffeine and nicotine) in the past 3 months; Received rTMS, tDCS, tACS, light therapy, ECT, MST, DBS therapy in the past 3 months; Serious suicide attempt (hamD-17 item 3 "suicide" score ≥3); Refuse to sign the informed consent.
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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The Role of Neuromodulation Technique In Depression Disorder

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