Evaluating Clinical Effectiveness of Acupuncture for Perimenopausal Depression (PMD) accompanying Insomnia

Phase 1

Recruiting

• Conditions: perimenopausal depression accompanying insomnia

• Registration Number: ITMCTR2100004380
• Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

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;
(11) Have any serious physical illness (such as serious cardiovascular, lung, liver, and kidney diseases, etc.);
(12) With alcohol or drug abuse/addiction;
(13) Have participated in any clinical trial in the last three months;
(14) With other conditions which makes them an unsuitable candidate for this trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HAMD-17;

Secondary Outcome Measures

Name	Time	Method
ISI;MS-TSQ;MENQOL;KI;SRRS;APS;Meno-D;Sleep hygiene behavior checklist;HAMA;MGHASS;sex hormone test;AES;PSQI;SCSQ;