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A double-blind, randomized, placebo controlled study of the efficacy of repeated transcranial magnetic stimulation (rTMS) combined with sertraline in the treatment of depression

A double-blind, randomized, placebo controlled study of the efficacy of repeated transcranial magnetic stimulation (rTMS) combined with sertraline in the treatment of depression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073584
Enrollment
Unknown
Registered
2023-07-14
Start date
2023-07-31
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

major depressive disorder

Interventions

Sertraline combined with sham stimulation group:Sertraline
Sertraline combined with rTMS treatment group:Sertraline combined with rTMS

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 65 Years

Inclusion criteria

Inclusion criteria: Meet The diagnostic criteria for depression of The diagnostic and statistical manual of mental disorders-5 (DSM-5); No previous antidepressant treatment, or antidepressant withdrawal for more than 2 weeks; Age: 13-65 years old; 17-item Hamilton Depression Rating Scale for depression (HAMD) score >7; Culture: primary school graduate or above, can understand the content of neuropsychological test; Race: Han nationality; Handedness: right-handed; Volunteer to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: Those with other DSM-V axis I and II disorders (e.g., schizophrenia, substance use-related disorders, mental retardation, etc.); Unstable medical conditions, such as pregnancy, breastfeeding, etc.; Have organic diseases of the brain, neurological diseases or serious endocrine or metabolic diseases; Patients with color blindness and color weakness may affect neurocognitive test related factors; Any implantable medical devices, metal objects in the head and neck (such as metal dentures, cardiac pacemakers, etc.) that affect rTMS treatment and MRI examination. A history of physical therapy

Design outcomes

Primary

MeasureTime frame
17-item Hamilton Depression Scale (HAMD-17);Beck Depression Inventory, BDI;Beck Anxiety Inventory, BAI;Hamilton Anxiety Scale ;Head MRI;

Secondary

MeasureTime frame
Pittsburgh sleep quality index, PSQI;Connor-Davidson resilience scale, CD-RISC;Social support rating scale, SSRS;Eysenck Personality Questionnaire, EPQ-88;Life Events Scale, LES;Adolescent Self-Rating Life Events Check List, ASLEC;Dimensional Anhedonia Rating Scale, DARS;The Cambridge Neuropsychological Automated Test Battery;the 14-item Hamilton Rating Scale for Anxiety (HAMA-14);Global Assessment Scale, GAS;Insight and Treatment Attitude Questionnaire, ITAQ;Insight and Treatment Attitude Questionnaire, ITAQ;Social Disability Screening Schedule, SDSS;Childhood Trauma Questionnaire, CTQ;

Countries

China

Contacts

Public ContactXiaohong Ma

West China Hospital of Sichuan University

maxiaohong@scu.edu.cn+86 189 8060 2101

Outcome results

None listed

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