- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05352113
Intradermal Needle Therapy for Major Depressive Disorder
27. april 2022 oppdatert av: Xiaomei Shao, The Third Affiliated hospital of Zhejiang Chinese Medical University
Major depressive disorder (MDD) is a common mental disorder that affects patients' physical health and quality of life.
Although traditional acupuncture therapy has certain advantages in improving MDD, there are still some limitations, such as being time-consuming and some people having a fear of acupuncture.
Therefore, intradermal needle therapy will be chosen in the treatment of MDD in this study, which is more convenient, shallow needling, and gentle than traditional acupuncture therapy.
The study is designed to investigate the therapeutic effect and safety of intradermal needles for MDD.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A total of 120 participants with MDD who meet the inclusion criteria will be included in the study.
Participants will be randomly divided into the SSRIs + acupuncture group, acupuncture + placebo group, and SSRIs + sham acupuncture group.
This study will evaluate the efficacy and safety of the intradermal needle for MDD and investigate whether the intradermal needle reduces side effects and increases the efficacy of selective serotonin reuptake inhibitors (SSRIs) antidepressants for MDD.
Furthermore, the study will demonstrate whether the intradermal needle has a synergistic effect with SSRIs on the treatment of MDD.
Studietype
Intervensjonell
Registrering (Forventet)
120
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: Xiaomei M Shao, Ph.D
- Telefonnummer: +8618957130287
- E-post: shaoxiaomei@zcmu.edu.cn
Studiesteder
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina
- Xiaomei Medical Shao
-
Ta kontakt med:
- Xiaomei M Shao
- Telefonnummer: +8618957130287
- E-post: shaoxiaomei@zcmu.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
12 år til 60 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 1. Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for depression and are evaluated as moderate or severe MDD according to the severity of depression; 2. 12 ≤ age ≤60, male or female; 3. Participants have clear consciousness and could communicate with others normally; 4. Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin (for minor participants, their guardian should sign the informed consent form for them).
Exclusion Criteria:
- 1. Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically; 2. Major depressive disorders caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances; 3. Participants with suicidal tendencies; 4. Pregnant or lactating participants; 5. Participants taking other antidepressants that were not SSRIs or the pharmacological effects of such antidepressants have not been cleared; 6. Participants with intellectual disabilities who cannot cooperate with the questionnaire survey; 7. Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape; 8. Participants are participating in other trials.
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: acupuncture + SSRIs group
This group will include 40 patients with MDD who will be treated with acupuncture and SSRIs antidepressants.
Acupoints related to MDD will be stimulated.
The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
|
SSRIs antidepressants will be used and the oral dose will be determined by the clinical specialist.
Once-daily for 6 weeks.
Andre navn:
This study will use the intradermal needle as an acupuncture intervention.
Acupoints related to MDD will be stimulated.
According to the position of the acupoints, choose a needle of φ0.20*1.5m
or φ0.20*1.2mm.
Press the needle to insert the acupoint vertically and retain it in the skin.
After the intervention, the needle will be retained for 72 hours with a day of rest after removal.
During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours.
A total of 10 treatment sessions will be performed for 6 weeks.
Andre navn:
|
Eksperimentell: acupuncture + placebo group
This group will include 40 patients with MDD who will be treated with acupuncture and a placebo.
Acupoints related to MDD will be stimulated.
The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
|
This study will use the intradermal needle as an acupuncture intervention.
Acupoints related to MDD will be stimulated.
According to the position of the acupoints, choose a needle of φ0.20*1.5m
or φ0.20*1.2mm.
Press the needle to insert the acupoint vertically and retain it in the skin.
After the intervention, the needle will be retained for 72 hours with a day of rest after removal.
During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours.
A total of 10 treatment sessions will be performed for 6 weeks.
Andre navn:
Oral placebo mimicking SSRIs antidepressants.
Once-daily for 6 weeks.
Andre navn:
|
Eksperimentell: sham acupuncture + SSRIs group
This group will include 40 patients with MDD who will be treated with sham acupuncture and SSRIs antidepressants.
The sham acupuncture will be needled on the points 1cm lateral to acupoints.
The oral dose of SSRIs antidepressants will be determined by the clinical specialist.
|
SSRIs antidepressants will be used and the oral dose will be determined by the clinical specialist.
Once-daily for 6 weeks.
Andre navn:
Sham acupuncture will use the same size, color, and material as the verum intradermal needle with a thin silicone pad in the middle instead of the needle body.
The sham acupuncture will be needled on the points 1cm lateral to MDD-related acupoints.
After the intervention, the needle will be retained for 72 hours with a day of rest after removal.
A total of 10 sessions will be performed for 6 weeks.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in the Hamilton Depression Scale-17 (HAMD-17)
Tidsramme: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
|
The HAMD scale is the most commonly used in the clinical assessment of depression, including 17 items.
The higher the score, the more severe the depression.
0-7 means no depressive symptoms, 8-17 means mild depression, 18-24 was divided into moderate depression, and 25-52 was divided into severe depression.
|
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in the Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
|
The PSQI is used to assess the sleep quality of the participant in the last 1 month and consisted of 19 self-rated and 5 other rated items.
The higher the score, the worse the sleep quality.
Sleep quality is divided into 4 levels according to the total score.
|
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
|
Change in the Treatment Emergent SymptomScale (TESS)
Tidsramme: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
|
The TESS scale rated each symptom on three dimensions: severity, the relationship between the symptom and the medication, and the measure taken.
|
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
|
Change in the MOS item short from health survey (SF-36)
Tidsramme: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
|
The SF-36 scale evaluates the quality of healthy life into 8 dimensions, which are divided into two categories: physical health and mental health, namely physical function (PF), role physical (RP), body pain (BP), general health (GH), vitality (VT), social function (SF), role emotional (RE), mental health (MH).
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Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Xiaomei M Shao, Ph.D, the Third Affiliated Hospital of Zhejiang Chinese Medical University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. mai 2022
Primær fullføring (Forventet)
1. mai 2025
Studiet fullført (Forventet)
30. desember 2025
Datoer for studieregistrering
Først innsendt
27. april 2022
Først innsendt som oppfylte QC-kriteriene
27. april 2022
Først lagt ut (Faktiske)
28. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2022ZX010-MDD
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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