Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

Depression Clinical Trial

Official title:

A Randomized Controlled Trial of Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838994
• Other study ID #: ACUP-002
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: January 12, 2010
• Start date: October 2007
• Est. completion date: April 2009

Study information

• Verified date: January 2010
• 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 1:1:1, i.e. equal chance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Willing to give informed consent;

• Hong Kong resident;

• Age 18-65 years;

• Previous DSM-IV Major Depressive Disorder as confirmed with the Structured Clinical Interview for DSM-IV;

• Hamilton Depression Rating Scale scores of 18 or below for at screening and baseline visit;

• A chief complaint of insomnia;

• Able to comply with the trial protocol.

Exclusion Criteria:

• Any symptoms suggestive of specific sleep disorders, including loud snoring, periodic leg movement, parasomnia;

• A diagnosis of sleep apnea or periodic limb movement disorder (PLMD) as assessed by overnight polysomnography (PSG);

• Presence of suicidal risk;

• Previous history of schizophrenia, other psychotic disorders, and bipolar disorder;

• Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception;

• Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe.

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, 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 (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Baptist University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-rated sleep quality score measured by Insomnia Severity Index questionnaire		Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.	No
Primary	Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy		Baseline, 1-week posttreatment, and 4-week posttreatment.	No
Primary	Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.		Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.	No
Secondary	Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire		Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.	No
Secondary	Depression state measured by Hamilton Depression Rating Scale (HAMD)		Baseline, 1-week posttreatment, and 4-week posttreatment.	No
Secondary	Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale		Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.	No
Secondary	Subjects' credibility to the treatment measured by Credibility of treatment rating scale		Second and the last time of the treatment.	No