- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05352113
Intradermal Needle Therapy for Major Depressive Disorder
27 april 2022 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Xiaomei M Shao, Ph.D
- Telefonnummer: +8618957130287
- E-post: shaoxiaomei@zcmu.edu.cn
Studieorter
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina
- Xiaomei Medical Shao
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Kontakt:
- Xiaomei M Shao
- Telefonnummer: +8618957130287
- E-post: shaoxiaomei@zcmu.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 60 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
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.
Andra namn:
|
Experimentell: 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.
Andra namn:
Oral placebo mimicking SSRIs antidepressants.
Once-daily for 6 weeks.
Andra namn:
|
Experimentell: 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.
Andra namn:
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in the Hamilton Depression Scale-17 (HAMD-17)
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in the Pittsburgh Sleep Quality Index (PSQI)
Tidsram: 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.
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Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
|
Change in the Treatment Emergent SymptomScale (TESS)
Tidsram: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
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The TESS scale rated each symptom on three dimensions: severity, the relationship between the symptom and the medication, and the measure taken.
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Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
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Change in the MOS item short from health survey (SF-36)
Tidsram: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
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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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Xiaomei M Shao, Ph.D, the Third Affiliated Hospital of Zhejiang Chinese Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 maj 2022
Primärt slutförande (Förväntat)
1 maj 2025
Avslutad studie (Förväntat)
30 december 2025
Studieregistreringsdatum
Först inskickad
27 april 2022
Först inskickad som uppfyllde QC-kriterierna
27 april 2022
Första postat (Faktisk)
28 april 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 april 2022
Senast verifierad
1 april 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2022ZX010-MDD
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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