A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture

Depression Clinical Trial

Official title:

The Identification of Central Neural Network for Antidepressant Effects of Dense Cranial Electroacupuncture Stimulation - a Positron Emission Topographic (PET) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479920
• Other study ID #: UW 09-091
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: December 4, 2015
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• 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

This is a randomized, assessor-blind, placebo controlled study in major depressive disorder (MDD) patients. Subjects receiving antidepressant drug (FLX) would be assigned to receive either 18 sham / active DCEAS for in 6 weeks. Changes in the severity of depressive symptoms over time are measured using depression rating scales. Brain glucose metabolic levels are measured using PET at baseline and endpoint. The most intriguing and expected result might be that acupuncture treated-patients may display comparable or even better outcomes and the clinical improvements by acupuncture are correlated with the restoration of the activities in the related brain regions.

Description:

Although the development of various classes of antidepressant drugs, represented by selective serotonin reuptake inhibitors (SSRI), has considerably improved the prognosis and the tolerability in the treatment of depressive disorders, the currently available antidepressant therapy is still incomplete, because there are about 40% of depressed individuals who cannot obtain full response and a large proportion of the patients experience recurrent episodes.

Recently the principal investigator has completed a clinical trial to test whether dense cranial electroacupuncture stimulation (DCEAS) could enhance the antidepressant efficacy in the early phase of SSRI treatment (fluoxetine, FLX) of major depressive disorder (MDD). It was found that DCEAS is clinically safe and effective in augmenting the antidepressant efficacy in early SSRI treatment. As we hypothesize that this normalizing effect is associated with the modulation of various nervous functions associated with the pathophysiology of MDD, we design this neuroimaging (PET) DCEAS study to delineate the related mechanisms.

The objective of this study are:

1) To compare clinical improvements on depressive symptoms between DCEAS and FLX monotherapy in MDD subjects; (2) To determine the effects of DCEAS treatment on glucose metabolic levels in related brain regions in comparison with healthy controls and FLX-treated patients, using PET scanning; and (3) To correlate between clinical improvements and changes in PET-measured activities of related brain regions in a pool of the subjects treated with DCEAS and FLX.

In this 6-week, assessor-blind, randomized, controlled study of DCEAS as additional treatment with the antidepressant drug FLX, a total of 82 patients with major depressive disorder (MDD) will be recruited. The patients will be randomly assigned to FLX (10-30 mg/day) combined with sham (n =41) or FLX with active DCEAS (n =41) (18 sessions, 3 sessions a week). Changes in the severity of depressive symptoms over time are measured using depressive instruments. Clinical response and remission rates are also calculated. Two sessions of PET scan will be conducted at baseline and endpoint. The study will be conducted at HKU School of Chinese Medicine, Queen Mary Hospital, and Kowloon Hospital, Hong Kong.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

1. with righthandedness;

2. have first-episode MDD diagnosed as the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV); and

3. HAMD-17 score is = 20; and

4. never had any psychoactive medications.

Exclusion Criteria:

1. unstable medical conditions;

2. have suicidal ideas or attempts or aggressive behavior;

3. previously experienced manic, hypomanic, or mixed episode;

4. immediate family members have bipolar or psychotic disorders;

5. treatment with investigational drugs in past 6 months;

6. alcoholism or drug abuse in past 1 year; or

7. have needle phobia.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Fluoxetine
Subjects of both study arms received orally administered SSRIs for 4 weeks in an open manner. For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day.

Procedure:
• DCEAS (Hwato®/ Dongbang®)
Six pairs of cranial acupoints are used: Baihui (Du-20) and Yintang (EX-HN3), left Sishencong (EX-HN1) and Toulinqi (GB15), right Sishencong (EX-HN1) and Toulinqi (GB15), bilateral Shuaigu (GB8), bilateral Taiyang (EX-HN5), and bilateral Touwei (ST8). All these acupoints are located on the forehead. Disposable acupuncture needles (Hwato®/ Dongbang®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into acupoints, on which low- and high-frequency alternating electrical stimulation with continuous waves is conducted for 30 min. The intensity is adjusted to a level at which patients feel comfortable.
• n-CEA (Strietberger®)
Streitberger's acupuncture needles will be applied on the same acupoints, with the same electrical stimulation parameters, except that the needles only adhere to the skin instead of insertion.

Locations

Country	Name	City	State
China	School of Traditional Chinese Medicine, Southern Medical University	Guangzhou
China	Department of Psychiatry, Queen Mary Hospital	Hong Kong
China	Department of Psychiatry, Kowloon Hospital	Kowloon
Hong Kong	Department of Diagnostic Radiology, The University of Hong Kong	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
The University of Hong Kong	Kowloon Hospital, Hong Kong, Queen Mary Hospital, Hong Kong, Southern Medical University, China

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAMD-17	Depression symptoms is measured using the 17-item Hamilton Depression Scale. Assessments will be conducted at baseline and once weekly thereafter.	42-day (course of treatment)	No
Primary	SDS	Depression symptoms is measured using the Self-Rating Depression Scale (SDS). Assessments will be conducted at baseline and once weekly thereafter.	42-day (course of treatment)	No
Secondary	PET scanning	The secondary outcome measure of high interest is the results of PET scanning. Two sessions of PET scan will be conducted at baseline and endpoint for enrolled subjects. An additional group of age- and gender-matched healthy subjects will be invited for one-session PET scan.	42-day (course of treatment)	Yes
Secondary	Clinical response	Clinical response, defined as greater than or equal to 50% reduction at endpoint from baseline on HAMD-17, is measured at the baseline and once weekly thereafter.	42-day (course of treatment)	No
Secondary	Remission	Remission, defined as 7 points or less on HAMD-17 score, is measured at the baseline and once weekly thereafter.	42-day (course of treatment)	No
Secondary	Latency	The latency of the clinical response.	42-day (course of treatment)	No
Secondary	Adverse events	Adverse events are assessed using the Treatment Emergent Symptom Scale (TESS) when applicable.	42-day (course of treatment)	Yes

External Links

•   HKU-SCM PET-RCT