Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

Depression Clinical Trial

Official title:

A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms Associated With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707706
• Other study ID #: ACUP-004
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: December 12, 2013
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on residual insomnia in major depressive patients.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Insomnia

Intervention

Other:
• Acupuncture
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Locations

Country	Name	City	State
Hong Kong	Western Psychiatry Centre	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire		Baseline, 1-week and 5-week posttreatment.	No
Secondary	Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire		Baseline, 1-week posttreatment, and 5-week posttreatment.	No
Secondary	Depression state measured by Hamilton Depression Rating Scale (HAMD)		Baseline, 1-week posttreatment, and 5-week posttreatment.	No
Secondary	Depression state measured by Hamilton Anxiety Rating Scale (HAMA)		Baseline, 1-week posttreatment, and 5-week posttreatment	No
Secondary	Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)		Baseline, 1-week posttreatment, and 5-week posttreatment.	No
Secondary	Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)		Baseline, 1-week posttreatment and 5-week posttreatment	No
Secondary	Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)		Baseline, 1-week posttreatment, and 5-week posttreatment	No
Secondary	Self-rated assessment regarding the degree of catastrophic thoughts about pain measured by Pain Catastrophizing Scale (PCS)		Baseline, 1-week posttreatment, and 5-week posttreatment.	No
Secondary	Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)		Baseline, 1-week posttreatment, and 5-week posttreatment.	No
Secondary	Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)		Baseline, 1-week posttreatment, and 5-week posttreatment	No
Secondary	Subjects' credibility to the treatment measured by Credibility of treatment rating scale		Baseline, second treatment (expected 3-day post-baseline ) and the last time of the treatment (expected 19-day post-baseline )	No
Secondary	Serious adverse events measured by Serious Adverse Event (SAE)		1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment	Yes
Secondary	Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture		1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment	Yes
Secondary	Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by objective measure - wrist actigraphy		Baseline, 1-week posttreatment, and 5-week posttreatment.	No
Secondary	Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.		Baseline, 1-week posttreatment, and 5-week posttreatment.	No