Clinical trial NCT01479920: A Positron Emission Topographic (PET) Study on Depression Patient With Electroacupuncture
Official title: The Identification of Central Neural Network for Antidepressant Effects of Dense Cranial Electroacupuncture Stimulation - a Positron Emission Topographic (PET) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Depression
Keywords: Depressive Disorder
Depressive Symptoms
Depressive Syndrome
Emotional Depression
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: Kowloon Hospital, Hong Kong
name: Southern Medical University, China
First posted: 2011-11-28
Enrollment: 36
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HAMD-17
timeFrame: 42-day (course of treatment)
measure: SDS
timeFrame: 42-day (course of treatment)
Secondary outcomes:
measure: PET scanning
timeFrame: 42-day (course of treatment)
measure: Clinical response
timeFrame: 42-day (course of treatment)
measure: Remission
timeFrame: 42-day (course of treatment)
measure: Latency
timeFrame: 42-day (course of treatment)
measure: Adverse events
timeFrame: 42-day (course of treatment)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: School of Traditional Chinese Medicine, Southern Medical University
city: Hong Kong
country: China
facility: Department of Psychiatry, Queen Mary Hospital
city: Kowloon
country: China
facility: Department of Psychiatry, Kowloon Hospital
city: Hong Kong
country: Hong Kong
facility: Department of Diagnostic Radiology, The University of Hong Kong
Study officials:
affiliation: School of Chinese Medicine, The University of Hong Kong
name: Zhang-Jin Zhang, MMed, PhD
role: PRINCIPAL_INVESTIGATOR
References: