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A randomized controlled study on the treatment of depressive disorder with transcranial direct current stimulation of the orbitofrontal cortex

Study on the treatment of depressive disorder with transcranial direct current stimulation of the orbitofrontal cortex

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034671
Enrollment
Unknown
Registered
2020-07-14
Start date
2020-07-20
Completion date
Unknown
Last updated
2020-07-20

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

Conditions

Depressive disorder

Interventions

A:OFC-tDCS 2mA 1time/day
B:OFC-tDCS 2mA 1time/day
C:dlPFC-tDCS 2mA 1time/day
D:dlPFC-tDCS 2mA 1time/day
E:OFC-Pseudo-stimulus 1time/day
F:dlPFC-Pseudo-stimulus 1time/day

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with depressive disorder diagnosed by dsm-5 (including unipolar depression and bipolar depression); 2. Patients aged from 14 to 65 years old; 3. Sex and nationality are not limited; 4. Patients with Hamilton depression score HAMD >= 8 and the first item >= 2; 5. For the patients who did not receive treatment related to depression other than drugs within two weeks of the inclusion time, the drugs and their doses remained unchanged during the treatment; 6. The objects whose educational level requires primary school or above; 7. Be able to accept the objects of numbness, slight tingling and other discomfort during the treatment process; 8. Adult patients should sign informed consent form (adult version), and minor patients should sign informed consent form (minor version) with their parents at the same time.

Exclusion criteria

Exclusion criteria: 1. Subjects with high suicide risk; 2. Pregnant women; 3. Patients with clinically diagnosed neurological disorders such as epilepsy, stroke, Alzheimer's disease, Parkinson's disease, etc.; 4. Patients with head trauma or skin diseases; 5. Patients with any implants or implantable devices interacting with tDCS current in the head; 6. Patients who had changed antidepressant drugs in the first two weeks; 7. Patients who have received any neuromodulation therapy in the past three months (e.g. (m) ect, (R) TMS, TES); 8. Patients with psychotic disorder, obsessive-compulsive disorder, phobia, panic disorder or stress-related disorder; 9. Patients with any type of substance abuse, such as alcohol and drugs, were included.

Design outcomes

Secondary

MeasureTime frame
Hamilton Anxiety Scale;Positive and Negative Syndrome Scale;Pittsburgh Sleep Quality Index;cognitive ability;Daily activity and sleep;Electroencephalogram data;

Primary

MeasureTime frame
HAMD-17reduction rate;

Countries

China

Contacts

Public ContactWu Hong

Shanghai Mental Health Center

drhongwu@126.com+86 13611978319

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026