Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

This is a randomized single-blinded controlled trial. Patients will be randomly assigned to one of the three groups. One is the traditional acupuncture treatment group, one is the non-traditional acupuncture treatment group and the other is an acupuncture-like placebo treatment. Patients will be put into groups and then compared. The chance of getting into each group is 2:2:1.

Inclusion criteria

• Aged 18 years or above
• A previous Diagnostic and Statistical Manual of Mental Disorders-IV Major Depressive Disorder
• Have a current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of insomnia disorder
• Insomnia more than 3 nights per week for at least 3 months
• Insomnia Severity Scale (ISI) total score higher than 15 at screening and baseline visit
• Use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
• Hypnotic dosage has not been increased in the last 4 weeks

Exclusion criteria

• Have a Hamilton Depression Rating Scale scores above 18
• Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
• Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
• Have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
• Have current alcohol or drug abuse and dependence
• Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
• Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
• Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
• Any acupuncture treatment during the previous 12 months prior to baseline and
• Unstable medical conditions.