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Research on the Clinical Symptom Improvement and Brain Mechanism of Patients with Refractory Depression Treated with Graphene Far-Infrared Radiation

Research on the Clinical Symptom Improvement and Brain Mechanism of Patients with Refractory Depression Treated with Graphene Far-Infrared Radiation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111801
Enrollment
Unknown
Registered
2025-11-06
Start date
2025-11-06
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Depression, anxiety, insomnia, loss of pleasure, etc

Interventions

Experimental group:Graphene far-infrared intervention

Sponsors

The Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age: 18 - 65 years old, right-handed; 2. Meets the diagnostic criteria for depression as stipulated in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3.Total score of HAMD-24 >= 20 points; 4.According to the Mosley Staging Method (MSM), there is moderate to severe treatment resistance, with a score higher than 6 points; 5.Physical examination, medical history, vital signs, routine blood, urine and stool tests, liver and kidney function, electrolytes, electrocardiogram, and electroencephalogram of the patient are all normal; 6.After fully understanding the safety of graphene far-infrared, the patient is willing to cooperate with the treatment and signs an informed consent form with both the patient and the family members; 7.All patients are taking selective serotonin reuptake inhibitors (SSRI) drugs.

Exclusion criteria

Exclusion criteria: 1.History of severe physical diseases and depression caused by psychoactive substances and non-addictive substances; 2.Patients with implanted metal or electronic devices, such as intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, and metal foreign bodies in the heart, etc.; 3. At risk of epileptic seizures, with previous cranial diseases, head trauma, alcohol abuse, abnormal electroencephalograms, MRI evidence of brain structural abnormalities, or a family history of epilepsy; 4.With psychotic symptoms requiring combined use of antipsychotic drugs; 5.Received ECT or other physical therapy within 3 months prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale (HAMD-24) Score;Hamilton Anxiety Scale (HAMA) Score;Montreal-Asberg Depression Scale (MADRS) Score;Pittsburgh Sleep Quality Index (PSQI);Snays-Hamilton Pleasure Scale (SHAPS) Score;Chinese Version of Beck Suicide Ideation Scale (BSI-CV) Score;Neuropsychological Status Assessment Scale (RBANS) Score;

Secondary

MeasureTime frame
Brain region activation, functional connectivity, plasticity changes, etc;

Countries

China

Contacts

Public ContactDongsheng Zhou

The Affiliated Kangning Hospital of Ningbo University

wyzhouds@sina.com+86 574 2630 2565

Outcome results

None listed

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