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Randomized controlled trial of buccal acupuncture for subthreshold depression

Randomized controlled trial of buccal acupuncture for subthreshold depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000341
Enrollment
Unknown
Registered
2024-08-31
Start date
2024-09-05
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

subthreshold depression

Interventions

Buccal acupuncture treatment group:Cheek needle therapy
Waiting group:Wait for treatment

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Subthreshold depression is defined as two or more depressive symptoms lasting for more than two weeks, most of the day, accompanied by some degree of occupational decline and social impairment, but does not meet the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) of the "major depressive episode" symptom indicators. The subjects were evaluated by the large-scale self-rating scale, and the high-risk groups of depression were selected, and then diagnosed by the Hamilton depression scale assessed by specialists. Specific inclusion criteria and exclusion criteria are as follows: Inclusion criteria (1) Meet the above diagnostic criteria for subthreshold depression; (2) Hamilton Depression Scale (HAMD-17) score: 7 = total HAMD score < 17; (3) Regardless of gender, age above 18 years old, under 55 years old; (4) Be able to complete the questionnaire independently, give informed consent and fill it out voluntarily. Note: Patients who meet the above four criteria may be included in this study.

Exclusion criteria

Exclusion criteria: Those with any of the exclusion criteria may not be included in clinical trials: (1) Clinically diagnosed patients with depression, previous mental illness or organic mental disorders; (2) suffering from serious heart, brain, liver, kidney, hematopoietic system and other diseases; (3) Pregnant and lactating women; Women of childbearing age who intend to have children; (4) episodes of depression caused by psychoactive and non-addictive substances; (5) Concurrent use of other depression medications or therapies during the trial; (6) a known alcoholic or substance dependent person; (7) The patient has a strong suicide attempt or behavior; (8) Participating in other clinical trials; (9) Patients who had received antidepressant treatment within 1 week before the trial. (10) Skull absence and skin infection scar at the acupuncture site affected the treatment; (11) Patients who are allergic to acupuncture or have experienced acupuncture dizziness; (12) Aged over 55 or under 18. Those who meet one of the above criteria are excluded.

Design outcomes

Primary

MeasureTime frame
HAMD reduction rate;

Secondary

MeasureTime frame
BDI-II Depression Self-rating Scale score;Quality of life scale;Resting state fMRI local consistency coefficient (ReHo) and low frequency amplitude (ALFF) differences in brain regions;Self-rating anxiety scale score;Pittsburgh Sleep Quality Index Scale score;

Countries

China

Contacts

Public ContactCheng Yu

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

18765800733@163.com18765800733

Outcome results

None listed

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