Multimodal MRI Study of Acupuncture's Rapid Antidepressant Mechanisms and Response Prediction in Depression
22. mai 2026 oppdatert av: Fan Chunling,MD, Second Affiliated Hospital of Tsinghua University
A Multimodal MRI-Based Study on the Rapid Antidepressant Mechanisms of Acupuncture and Individualized Treatment Response Prediction in Depression
This study aims to investigate the rapid antidepressant effects of acupuncture and to explore the underlying brain mechanisms using multimodal MRI techniques. In addition, the study will evaluate whether individual treatment responses can be predicted based on neuroimaging and clinical data.
Participants diagnosed with mild to moderate depression will be enrolled and will receive acupuncture treatment. Depression-related clinical assessment scales and brain imaging data will be collected before and after treatment.
The results of this study may help to better understand the mechanisms of acupuncture in rapid antidepressant treatment and support the development of personalized treatment strategies.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Chunling Fan, M.D.
- Telefonnummer: +86 10 89926000
- E-post: fanjingzi1@126.com
Studer Kontakt Backup
- Navn: YU MA, M.D.
- Telefonnummer: +86 10 89926000
- E-post: mayu@tsinghua.edu.cn
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Aged 18 to 59 years, and right-handed;
- Patients who have received systematic antidepressant treatment (including antidepressant medications, sedative-hypnotics, electroconvulsive therapy, or transcranial magnetic stimulation) within the 4 weeks prior to enrollment;
- Having a total score on the 17-item Hamilton Depression Rating Scale (HAMD-17) greater than 7 and less than or equal to 24;
- Voluntary participation in the study, with written informed consent provided by the patient themselves or their legally authorized guardian.
Exclusion Criteria:
- Diagnosis of other major psychiatric disorders or presence of psychotic symptoms.
- History of other severe somatic diseases (e.g., cardiovascular/cerebrovascular diseases, autoimmune diseases), or current/past neurological or organic brain diseases.
- Current or past history of alcohol dependence or abuse of other psychoactive substances.
- Women who are lactating, pregnant, or menstruating.
- Patients who have participated in other clinical drug trials within the past 3 months.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Acupuncture group
Participants in the acupuncture group will receive real acupuncture treatment.
Acupoints will be selected according to the Chinese national standard "Nomenclature and Location of Meridian Points" (GB/T 12346-2006), including Baihui (GV20), Sishencong (EX-HN1), Shenting (GV24), Touwei (ST8), Fengchi (GB20), Anmian (EX-HN22), Neiguan (PC6), Shenmen (HT7), and Sanyinjiao (SP6).
Electrical stimulation will be applied using sparse-dense waves at frequencies of 2 Hz and 100 Hz, with an intensity ranging from 0.1 to 1 mA.
Treatment will be performed by licensed acupuncturists following a standardized operation manual.
Each acupuncture session lasts 30 minutes, and participants will receive one session of acupuncture treatment.
Participants will remain blinded to group allocation.
|
Participants will receive standardized acupuncture treatment for mild to moderate depression according to the study protocol.
Acupuncture will be administered by qualified practitioners at predefined acupoints during the treatment period.
|
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Sham-komparator: Sham Acupuncture Group
Participants in the sham acupuncture group will receive sham acupuncture using non-insertive placebo needles.
The same acupoints and treatment protocol will be applied as in the acupuncture group (sham acupuncture session lasting 30 minutes, single session).
The procedure mimics real acupuncture without skin penetration or active stimulation, and appears visually indistinguishable from real acupuncture.
The electroacupuncture device will not deliver electrical output.
Participants will remain blinded to group allocation.
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Participants will receive sham acupuncture as a control intervention using non-therapeutic acupuncture procedures designed to mimic acupuncture without providing active therapeutic effects.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale Score
Tidsramme: Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
|
Change in short-term depressive symptom severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), a 10-item scale with a total score ranging from 0 to 60. Higher scores indicate worse depression outcomes.
|
Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hamilton Depression Rating Scale
Tidsramme: Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
|
Change in short-term depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAMD-17).
The total score ranges from 0 to 52, with higher scores indicating more severe depression.
|
Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
|
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Positive and Negative Affect Schedule
Tidsramme: Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
|
Change in short-term positive and negative affect measured by the Positive and Negative Affect Schedule (PANAS).
The PANAS consists of two 10-item subscales: Positive Affect (PA) and Negative Affect (NA), each with a total score ranging from 10 to 50.
For the PA subscale, higher scores indicate better outcomes (greater positive affect).
For the NA subscale, higher scores indicate worse outcomes (greater negative affect).
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Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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Maudsley Three-Item Visual Analogue Scale
Tidsramme: Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
|
Change in short-term subjective mood state measured by the Maudsley Three-Item Visual Analogue Scale.
The scale consists of three separate visual analogue items (e.g., happiness, anxiety, depression), each scored from 0 to 100 mm (0 = absence of the feeling, 100 = extreme feeling).
For the happiness item, a higher score indicates a better outcome.
For the anxiety and depression items, higher scores indicate worse outcomes.
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Pre-acupuncture; 1 hour, 24 hours, and 3 days post-acupuncture
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
10. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
28. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026LH001
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