Clinical trial NCT05605002: Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder
Official title: Efficacy and Safety of Intradermal Acupuncture for Major Depressive Disorder: a Study Protocol for a Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Intradermal Acupuncture
Magnetic Resonance Imaging
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Tongde Hospital
name: First People's Hospital of Hangzhou
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
First posted: 2022-11-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depressive disorder (MDD) is a common mental illness that severely affects the health and quality of life of patients. Treatment with acupuncture alone or a combination of appropriate adjuncts has been reported to be significantly effective in reducing the severity of MDD, relieving patients' somatic symptoms and improving sleep. This study will focus on the intradermal acupuncture, which is more convenient, gentler and has longer lasting effects. The aim is to study the efficacy and safety of intradermal acupuncture for MDD, and to preliminarily explore the central nervous mechanisms by which it exerts its therapeutic effects.

Detailed description: A total of 90 patients with MDD who meet the inclusion criteria will be included in the study. 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 will assess the efficacy and safety of intradermal acupuncture for MDD and examine whether intradermal acupuncture reduces side effects and improves the efficacy of SSRIs for MDD. In addition, the study will use magnetic resonance imaging (MRI) to study the possible central mechanisms by which intradermal acupuncture exerts its antidepressant effects.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with MDD according to the International Classification of Disease-10 (ICD-10);
2. Aged between 18 and 60 years (no limitation on gender);
3. No depression-related treatment in the past two weeks, except SSRIs;
4. Patients undergoing MRI and MRS should be right-handed and free of traumatic brain injury, claustrophobia or metal implants;
5. 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: 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 Treatment Emergent Symptom Scale (TESS) Scores
timeFrame: Baseline, 6 weeks after treatment
measure: Adverse Events
timeFrame: Up to 10 weeks
Other outcomes:
measure: Magnetic resonance imaging (MRI) data acquisition
timeFrame: Baseline, 6 weeks after treatment
measure: Magnetic resonance spectroscopy (MRS ) data acquisition
timeFrame: Baseline, 6 weeks after treatment
measure: Blood samples biobank establishment
timeFrame: Baseline, 6 weeks after treatment
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: