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Effectiveness of iTBS in stimulating the V1 region of visual cortex versus classical target region in patients with depression—a randomized, double-blind, non-inferiority trial

Effectiveness of iTBS in stimulating the V1 region of visual cortex versus classical target region in patients with depression—a randomized, double-blind, non-inferiority trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039353
Enrollment
Unknown
Registered
2020-10-24
Start date
2020-10-26
Completion date
Unknown
Last updated
2023-02-13

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

Conditions

Depression

Interventions

Group 1:iTBS(L-DLPFC), SSRIs, SSNIs antidepressant
Group 2:iTBS(L-V1), SSRIs, SSNIs antidepressant

Sponsors

Zhongda Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Subjects who meet or reach the diagnostic criteria of unipolar depression; 2. Subjects with Hamilton Depression Scale (17 items) score >= 18; 3. Subjects aged 18-55 years; 4. The subjects who signed the informed consent voluntarily and were able to comply with the treatment plan and complete all the studies; 5. The subjects without obvious mental retardation can understand the questionnaire and evaluate the related questions.

Exclusion criteria

Exclusion criteria: 1. Patients with the following diseases: schizophrenia, paranoia, bipolar disorder, dementia, or other severe cognitive impairment, mental disorders caused by physical diseases or substance abuse; 2. Patients with history of brain trauma or other known organic diseases of central nervous system; 3. The subjects with psychotic symptoms and suicidal behavior in the course of depression attack; 4. Subjects with endocrine disease, blood disease or obvious abnormality of heart, liver and kidney function; 5. Patients who had received electroconvulsive therapy or rTMS; 6. Subjects who are taking antidepressants other than SSRIs and SNRIs and do not accept dressing change; 7. Patients with contraindications of rTMS or MRI.

Design outcomes

Primary

MeasureTime frame
17-item Hamilton Rating Scale for Depression;adverse events scale;

Secondary

MeasureTime frame
Montgomery Depression Rating Scale;Beck suicide ideation scale;life events scale;mini-mental state examination;Montreal cognitive assessment;cognitive task;visual evoked potential;event-related potential P300;

Countries

China

Contacts

Public ContactZhijun Zhang

Zhongda Hospital

janemengzhang@vip.163.com+86 13851687583

Outcome results

None listed

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