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Clinical efficacy and possible mechanism of hypothermia combined with antidepressants in the treatment of major depressive disorder

Clinical efficacy and possible mechanism of hypothermia combined with antidepressants in the treatment of major depressive disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088544
Enrollment
Unknown
Registered
2024-08-21
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

major depressive disorder

Interventions

Hypothermia combined with antidepressant treatment group:Hypothermia combined with antidepressant
Normothermic combined with antidepressant treatment group:Normal temperature combined with antidepressant
Healthy control group:None

Sponsors

Zhongda Hospital, School of Medicine, Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients group: ? Hospitalized patients; ? Aged 18-65 years (including 18 and 65 years old), male or female; ? Meet the diagnostic criteria of DSM-5 for depression; ? Patients with depression, 20 <= HAMD-24; ? No history of electroconvulsive therapy; ? Those who have not used psychotropic medication in the past two weeks; ? Those who have not used probiotics in the past one weeks; ? Subjects or their legal guardian sign the informed consent form. Healthy group: ? Select healthy individuals who match the patient group in terms of gender, age, education level, and HAMD-24 rating of<8 points; ? No history of serious heart, brain, or kidney diseases; ? No history of alcohol and drug abuse; ? No family history of mental illness; ? Subjects or their legal guardian sign the informed consent form.

Exclusion criteria

Exclusion criteria: ? History of schizophrenia, alcohol and drug dependence; ? Patients with organic brain diseases and endocrine diseases; ? Patients with severe primary diseases of cardiovascular, liver, and kidney diseases; ? Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Scores of HAMD-24;

Secondary

MeasureTime frame
MDD related hormone levels;PHQ-9/GAD-7;SERS;Daily monitoring of subjects' body temperature;16S rRNA gene sequencing;CircRNAs specifically expressed in MDD;

Countries

China

Contacts

Public ContactYonggui Yuan

Zhongda Hospital, Affiliated to Southeast University

yygylh2000@sina.com+86 139 1393 9082

Outcome results

None listed

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