The Role of Neuromodulation Technique In Depression Disorder

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: drug therapy; Device: rTMS; Device: light therapy; Device: ECT; Device: MST

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / 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.	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.
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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of the HAMD-17 score	the change of HAMD-17 score between baseline and after treatment.	baseline, and 1, 2, 4, 8, 12, 24, 36, 48 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
remission rate	HAMD-17 total score ≤ 7 after treatment.	12, 24, 36, 48 weeks.
response rate	a reduction rate of HAMD-17 score ≥ 50% from baseline after treatment.	12, 24, 36, 48 weeks.

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2020-74

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No