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Trial registered on ANZCTR


Registration number
ACTRN12610000370000
Ethics application status
Approved
Date submitted
28/04/2010
Date registered
10/05/2010
Date last updated
2/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional Magnetic Resonance Imaging (fMRI) investigation of Laser Acupuncture on Acupoints useful in Mild to Moderate Unipolar Depression.
Scientific title
Functional magnetic resonance imaging (fMRI) of laser acupuncture on unipolar depressed subjects using highly significant acupoints for mild to moderate depression by randomised controlled trial.
Secondary ID [1] 251664 0
Nil
Universal Trial Number (UTN)
Trial acronym
MRIMDD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unipolar depression 257264 0
Condition category
Condition code
Alternative and Complementary Medicine 257403 257403 0 0
Other alternative and complementary medicine
Mental Health 257404 257404 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Laser acupuncture to 4 acupoints found by double blind randomised controlled trial to be highly significant in the treatment of depression, and to a fifth acupoint KI3 added for anxiety management according to Traditional Chinese Medicine diagnosis or TCM diagnosis).
2. The acupoints are lasered in random order and the process repeated once so each acupoint is lasered twice in a single session.
3. The fibreoptic laser is a 804nm continuous beam laser, 25mW delivered over 20 seconds per block (0.5Joules).Total 35 minutes in the scanner, actual laser time being
4. Nine Rest blocks alternate with eight Active laser blocks. Blocks are 20 seconds duration.
5. Acupoints used were LR14, CV14, HT7 and LR8 from the randomised controlled trial amd KI3.
LR14 on right at 6th intercostal space, midclavicular line
CV14 in epigastrium about 10cm from the xiphisternum
HT7 is at left medial wrist
LR8 is at medial knee on Left between semimembranosis and semitendinosus muscles.
KI3 is at right medial knee.
Intervention code [1] 256382 0
Treatment: Other
Comparator / control treatment
Control is the sham laser / rest components of the block design.
Control group
Placebo

Outcomes
Primary outcome [1] 258328 0
Brain positive and negative activation patterns from laser acupuncture to acupoints CV14, LR14, HT7, LR8 and KI3 in unipolar depressed subjects
Timepoint [1] 258328 0
At the conclusion of the single session using MatLab and Statistical Parametric Mapping ( SPM)
to analyse the significant positive and negative activations from laser to the acupoints LR14, CV14,
Secondary outcome [1] 264037 0
Nil
Timepoint [1] 264037 0
Nil

Eligibility
Key inclusion criteria
1.Unipolar depression according to Diagnostic and Statistical Mental Health Manual Version IV ( DSM-IV)
2.Montgomery Anxiety and Depression Rating Scale (MADRS) score over 12
3.Hamilton Depression Scale (HAM-D) score over 12
4. Able to give informed consent
5. Depression of less than 2 years duration
6. Right handed
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Non unipolar depression
2. Depression of over 2 years duration
3. Chronic dysthmia
4. Suicidal tendencies
5. Pregnancy
6. Chronic uncontrolled illness
7. Brain Injury
8. Conditions contraindicated for magnetic
resonance imaging ( pace maker, metallic
foreign bodies)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment was by online advertisement to personnel in the Prince of Wales and Sydney Childrens Hospital as well as the University of New South Wales. Flyers were made and distributed to general practices in the district. Those who fulfilled the MADRS score were then invited for a face to face interview to score on the HAM-D. Positive scores to both these were necessary for recruitment. All subjects received real laser in block design as described and the order of acupoints being lasered was randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Acupoint randomisation was by draw lots. The 5 acupoints were written down on paper lots and placed in a box. Order of drawing was order of acupoint stimulation. The repeat acupoint stimulation was also similarly randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
5/08/2005
Date of last participant enrolment
Anticipated
Actual
8/12/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2865 0
2031
Recruitment postcode(s) [2] 2879 0
2069

Funding & Sponsors
Funding source category [1] 256885 0
Hospital
Name [1] 256885 0
Prince of Wales Hospital
Country [1] 256885 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Dr Im Quah-Smith
Neuropsychiatric Institute NPI
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 256158 0
None
Name [1] 256158 0
Nil
Address [1] 256158 0
Country [1] 256158 0
Other collaborator category [1] 1241 0
Individual
Name [1] 1241 0
Dr Mark Williams
Address [1] 1241 0
Macquarie Centre for Cognitive Sciences MACCS
Macquarie University
North Ryde
NSW 2113
Country [1] 1241 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258898 0
Human Research Ethics Committee South East Health , South East Sydney Area Health Service (SEAHS)
Ethics committee address [1] 258898 0
Ethics committee country [1] 258898 0
Australia
Date submitted for ethics approval [1] 258898 0
Approval date [1] 258898 0
10/05/2005
Ethics approval number [1] 258898 0
05-073

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31106 0
Dr Im Quah-Smith
Address 31106 0
Roseville Wellness Group
3/32 Barcoo Street
Roseville
NSW 2069
Country 31106 0
Australia
Phone 31106 0
612 94174772
Fax 31106 0
Email 31106 0
jiqs@tpg.com.au
Contact person for public queries
Name 14353 0
DR Im Quah-Smith
Address 14353 0
Roseville Wellness Group
3/32 Barcoo Street
Roseville
NSW 2069
Country 14353 0
Australia
Phone 14353 0
612 94174772
Fax 14353 0
612 94755035
Email 14353 0
jiqs@tpg.com.au
Contact person for scientific queries
Name 5281 0
Prof Perminder Sachdev
Address 5281 0
Neuropsychiatric Institute NPI
Prince of Wales Hospital PoWH
Barker Street
Randwick NSW 2031
Country 5281 0
Australia
Phone 5281 0
612 9382 3763
Fax 5281 0
612 9382 3774
Email 5281 0
psachdev@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.