ITMCTR2100004380
Recruiting
Phase 1
Evaluating Clinical Effectiveness of Acupuncture for Perimenopausal Depression (PMD) accompanying Insomnia
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- perimenopausal depression accompanying insomnia
- Sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Aged 45\-55 years;
- •(2\) Experiencing the perimenopausal phase;
- •(3\) Meeting the International Classification of Diseases\-Ten Edition (ICD\-10\) diagnostic criteria for mild or moderate depressive episode and International Classification of Sleep Disorders\-Third Edition (ICSD\-3\) diagnostic criteria for insomnia; Minimum duration of the depression episode accompanying insomnia is about four weeks;
- •(4\) 8 points \<\= HAMD\-17 \<\= 23 points;
- •(5\) PSQI \> 5 points;
- •(6\) In accordance with the diagnostic criteria for Depression of Liver and Deficiency of Kidney in TCM theory;
- •(7\) Volunteering to join this trial and sign a written informed consent form.
Exclusion Criteria
- •(1\) Belong to non\-natural menopause transition due to premature ovarian failure, medication intake, or surgery (e.g., oophorectomy);
- •(2\) Are pregnant or currently lactating;
- •(3\) Depression or insomnia is caused by systemic diseases (e.g., stroke, Parkinson's disease, surgery, etc.);
- •(4\) Are diagnosed as severe depressive episode according to ICD\-10 and/or have ideas or acts of suicide;
- •(5\) Had a depressive disorder diagnosis prior to perimenopausal phase;
- •(6\) Comorbid with other psychiatric and mental disorders, other depression\-related disorder, or sleep\-related disorders diagnosed by DSM\-V and ICD\-10 in addition to depression and insomnia;
- •(7\) Take medications (e.g., antidepressant, hypnotic, other psychotropic substances, Chinese herbal medicine, etc.) and/or health care products (e.g., melatonin, black cohosh, etc.), or receive other therapies (e.g., CBT, Mindfulness\-Based Exercise, etc.) that are intended to treat depression and insomnia within the last one month prior to the commencement of this trial;
- •(8\) Receive hormones therapy within the last two months prior to the commencement of this trial;
- •(9\) Had acupuncture treatment experience in the past 3 months;
- •(10\) Have an infection close to the position of the specified acupoints;
Outcomes
Primary Outcomes
Not specified
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