Intradermal Needle Therapy for Major Depressive Disorder
2022年4月27日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Xiaomei M Shao, Ph.D
- 電話番号：+8618957130287
- メール：shaoxiaomei@zcmu.edu.cn
研究場所
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- Xiaomei Medical Shao
-
コンタクト：
- Xiaomei M Shao
- 電話番号：+8618957130287
- メール：shaoxiaomei@zcmu.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年～60年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
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.
他の名前：
|
|
実験的：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.
他の名前：
Oral placebo mimicking SSRIs antidepressants.
Once-daily for 6 weeks.
他の名前：
|
|
実験的：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.
他の名前：
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the Hamilton Depression Scale-17 (HAMD-17)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the Pittsburgh Sleep Quality Index (PSQI)
時間枠：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)
時間枠：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)
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Xiaomei M Shao, Ph.D、The Third Affiliated hospital of Zhejiang Chinese Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2022年5月1日
一次修了 (予想される)
2025年5月1日
研究の完了 (予想される)
2025年12月30日
試験登録日
最初に提出
2022年4月27日
QC基準を満たした最初の提出物
2022年4月27日
最初の投稿 (実際)
2022年4月28日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月28日
QC基準を満たした最後の更新が送信されました
2022年4月27日
最終確認日
2022年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。