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Clinical study of transcranial magnetic stimulation combined with electroconvulsive therapy to improve the efficacy index in major mental disorders

Clinical study of transcranial magnetic stimulation combined with electroconvulsive therapy to improve the efficacy index in major mental disorders

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044665
Enrollment
Unknown
Registered
2021-03-25
Start date
2021-04-07
Completion date
Unknown
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major mental disorders

Interventions

healthy control group:Nil
Depressive patients treated with MECT:Nil
Bipolar disorder group:Nil
experimental group:MECT+TMS
control group:MECT+ sham TMS

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.1 Major Depressive disorder In the first stage, 100 subjects with depression were planned to be included, and in the second stage, 50 subjects were planned to be included. Inclusion criteria were as follows: (1) meeting the diagnostic criteria for depression through the SCID-IV clinical interview; (2) 18-50 years old, right-handed, Han nationality; (3) The Hamilton Depression Scale (HAMD-24) score was above 20 points; (4) IQ>70 scores (Wechsler Intelligence Scale); 1.2 Bipolar disorder In the first stage, 100 subjects with bipolar disorder were planned to be included, and in the second stage, 50 subjects were planned to be included. Inclusion criteria were as follows: (1) meeting the diagnostic criteria for bipolar disorder through the SCID-IV clinical interview; (2) 18-50 years old, right-handed, Han nationality; (3) IQ>70 scores points (Wechsler Intelligence Scale); 1.3 Schizophrenia In the first stage, 100 subjects with schizophrenia were planned to be included, and in the second stage, 50 subjects were planned to be included. Inclusion criteria were as follows: (1) meeting the diagnostic criteria for schizophrenia through the SCID-IV clinical interview; (2) 18-50 years old, right-handed, Han nationality; (3) PANSS score >= 60 points at baseline; (4) cooperating to complete the evaluation content of the assessment; (5) IQ > 70 scores (Wechsler Intelligence Scale); 1.4 Healthy control subjects In the first stage, 100 patients with healthy control subjects will be included, and the inclusion criteria are as follows: (1) In good health, no disease meeting DSM-IV Axis I diagnostic criteria by SCID screening; (2) No history of mental illness; (3) No serious physical disease; (4) 18-50 years old, right-handed, Han nationality; (5) cooperating to complete the evaluation content of the project; (6) Matching with age, gender and education level of the patient group; (7) IQ > 70 scores (Wechsler Intelligence Scale); (8) Have lived in Chengdu, Sichuan for more than 6 months, and the emotion is stable in the past 3 months; (9) No major operation in the past 3 years; (10) The social function is intact (able to go to work, go to school normally, and retire without illness), with full behavioral ability and responsibility ability.

Exclusion criteria

Exclusion criteria: 2.1 Exclusion criteria for all patients (1) A history of substance dependence; have a mental illness or history that meets SCID axis I diagnostic criteria; history of brain injury, epilepsy or other brain organic disease; (2) Laboratory examination shows liver and kidney function impairment or other serious physical diseases and metabolic disorders; (3) Meeting contraindications of MRI and MECT; (4) Pregnant women or lactating patients; (5) Previous family history or seizure history of epilepsy. 2.2 Exclusion criteria for healthy controls (1) A history of substance dependence; Any mental illness or history that can meet criteria of SCID axis I or II; history of brain injury, epilepsy or other brain organic disease; (2) a history of disturbance of consciousness; (3) Two-line and third-generation family history of mental illness was positive; (4) History of taken antipsychotics and antidepressants; Use of benzodiazepines or other drugs affecting the central nervous system in the month prior to MRI examination; Received continuous medication within 6 months; (5) No cooperate or effectively complete the test; (6) Laboratory examination shows liver and kidney function impairment or other serious physical diseases and metabolic disorders; (7) Meeting contraindications of MRI and MECT; (8) Pregnant women or lactating patients; (9) Color blindness.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale;Hamilton Anxiety Scale;Scale for Suicide Ideation;Young manic rating scale;positive and negative syndrome scale;Self-rating depression scale;Self—Rating Anxiety scale;Psychotic Symptom Rating Scales;motor thresholds;silent period;Intracortical inhibition;Intracortical facilitation;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Life event scale;Childhood Trauma Scale;Clinical Global Impression;personal and social performance scale;Montreal Cognitive Assessment;TrailMakingTest;symbolic coding;visuo-spatial working memory;Raven's Standard Progressive Matrices;autobiographicalmemory test;Autobiographical Memory Interview-Short Form;

Countries

China

Contacts

Public ContactDeng Wei

West China Hospital of Sichuan University

likunyjs@163.com+86 18980605805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026