Clinical trial NCT05832619: Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder
Official title: Intradermal Acupuncture Versus Sham Acupuncture and SSRI for Treating Adolescents With Major Depressive Disorder: a Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Intradermal Acupuncture
Randomized Controlled Trial
Adolescent
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depressive disorder (MDD) is a prevalent mental illness characterised by influencing the health and quality of life of patients，often manifesting in individuals under the age of 18. It has been wildly confirmed that acupuncture alone or in combination with the applicable adjuvant therapy for MDD can not only relieve patients' physical symptoms, but also enhance sleep quality. Intradermal acupuncture, as an acceptable and long-lasting treatment modality, is the focus of this research. This study was conducted to investigate the efficacy of intradermal acupuncture in the treatment of MDD.

Detailed description: This study will enroll a total of 120 adolescents with MDD who meet the inclusion criteria. Participants will be randomly assigned 1:1:1 to the waiting list group (patients in this group will be treated with selective 5-hydroxytryptamine reuptake inhibitors (SSRIs) only), sham intradermal acupuncture combined with SSRIs (SIA) group and active intradermal acupuncture combined with SSRIs (AIA) group. The study is aim to evaluate the efficacy of intradermal acupuncture for MDD and examine whether intradermal acupuncture reduces side effects and improves the efficacy of SSRIs for MDD.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10); HAMD-17≥7
2. Aged between 12 and 17 years (no limitation on gender);
3. Take SSRI for at least two weeks;
4. Written informed consent is obtained by the person or guardian.

Exclusion Criteria:

1. ICD-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction;
2. Significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system;
3. Acute suicidal tendency;
4. Allergy to adhesive tape and fear of intradermal acupuncture;
5. Pregnancy and lactation;
6. Mental retardation and difficult to cooperate with doctors.
7. Participating in other clinical trials.

Primary outcomes:
measure: Changes in the Hamilton Depression Scale-17 (HAMD-17) Scores
timeFrame: [Time Frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.]
Secondary outcomes:
measure: Changes in the Self-Rating Depression Scale (SDS) Scores
timeFrame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
measure: Changes in the Pittsburgh Sleep Quality Index (PSQI) Scores
timeFrame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
measure: Changes in the Patient Health Questionaire-9 (PHQ-9)
timeFrame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
measure: Changes in the Short Form 36 Questionnaire（SF-36）
timeFrame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Xiaomei Shao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: