The Role of Neuromodulation Technique In Depression Disorder

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05047159

Collaborator

(none)

450

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Device: rTMS Device: light therapy Device: ECT Device: MST Drug: drug therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: drug therapy group Drug: drug therapy There is no restriction on the choice of therapeutic drugs.	Drug: drug therapy There is no restriction on the choice of therapeutic drugs.
Experimental: drug therapy combined with repetitive transcranial magnetic stimulation (rTMS) group 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: 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.
Experimental: drug therapy combined with light therapy group 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: 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.
Experimental: drug therapy combined with electroconvulsive therapy (ECT) group 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: 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.
Experimental: drug therapy combined with magnetic seizure therapy (MST) group 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.	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.

Outcome Measures

Primary Outcome Measures

the change of the HAMD-17 score [baseline, and 1, 2, 4, 8, 12, 24, 36, 48 weeks.]
the change of HAMD-17 score between baseline and after treatment.

Secondary Outcome Measures

remission rate [12, 24, 36, 48 weeks.]
HAMD-17 total score ≤ 7 after treatment.
response rate [12, 24, 36, 48 weeks.]
a reduction rate of HAMD-17 score ≥ 50% from baseline after treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Mental Health Center	Shanghai	Shanghai	China	200030

Sponsors and Collaborators

Shanghai Mental Health Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Mental Health Center

ClinicalTrials.gov Identifier:

NCT05047159

Other Study ID Numbers:

2020-74

First Posted:

Sep 16, 2021

Last Update Posted:

Mar 22, 2022

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depressive Disorder

Depressive Disorder, Major

Study Results

No Results Posted as of Mar 22, 2022