Residual sleep disturbances in patients remitted from major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Men or women aged 18-70 years; (2) Met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for MDD; (3)Taken fixed dose of the same antidepressant at least 12 weeks before the baseline review or during study participation; (4) HAMD-17 scores=17; (5) Insomnia at least 3 nights a week, which lasted for at least three months,PSQI scores=7; (6) ISI scores=15; (7) All subjects must give full informed consent to this project and sign a written informed consent form before being enrolled in this study.
Exclusion criteria
Exclusion criteria: (1) Participants at high risk of suicide; (2) Having a history of schizophrenic, other psychiatric disorders,or bipolar disorder; (3) Having current alcohol abuse or substance related disorder; (4) Women who are pregnant or lactating or planning to be pregnant during the study; (5) Subjects who have inflammation or abscess at the planned acupuncture site on the body; (6) Subjects who have any other serious illness;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index,PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index,ISI;Hamilton Depression Scale,HAMD17;Hamilton Anxiety Scale,HAMA17;SF-36;Adverse events; | — |
Countries
China
Contacts
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University