Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Intradermal Needle Therapy for Major Depressive Disorder

27 aprile 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Zhejiang
      • Hangzhou, Zhejiang, Cina

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 60 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: SSRIs
SSRIs antidepressants will be used and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.
Altri nomi:
  • Antidepressivi SSRI
Procedura: acupuncture
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.
Altri nomi:
  • ago intradermico
Sperimentale: 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.
Procedura: acupuncture
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.
Altri nomi:
  • ago intradermico
Droga: placebo
Oral placebo mimicking SSRIs antidepressants. Once-daily for 6 weeks.
Altri nomi:
  • placebo mimicking SSRIs antidepressants
Sperimentale: 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.
Droga: SSRIs
SSRIs antidepressants will be used and the oral dose will be determined by the clinical specialist. Once-daily for 6 weeks.
Altri nomi:
  • Antidepressivi SSRI
Procedura: sham acupuncture
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.
Altri nomi:
  • finto ago intradermico

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the Hamilton Depression Scale-17 (HAMD-17)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the Pittsburgh Sleep Quality Index (PSQI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).
Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaboratori

The Zhejiang Provincial Tongde Hospital
The Affiliated Hangzhou First People's Hospital

Investigatori

  • Investigatore principale: Xiaomei M Shao, Ph.D, The Third Affiliated hospital of Zhejiang Chinese Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 maggio 2022

Completamento primario (Anticipato)

1 maggio 2025

Completamento dello studio (Anticipato)

30 dicembre 2025

Date di iscrizione allo studio

Primo inviato

27 aprile 2022

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2022

Primo Inserito (Effettivo)

28 aprile 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2022

Ultimo verificato

1 aprile 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2022ZX010-MDD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Disturbo depressivo maggiore

Prove cliniche su SSRIs

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Dominican Republic

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi