Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000340033
Ethics application status
Approved
Date submitted
13/09/2008
Date registered
28/04/2010
Date last updated
2/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laser Acupuncture in Depression Study
Scientific title
A Clinical and Experimental Study on the Efficacy of Laser Acupuncture in the Treatment of Major Depression Compared to Placebo Laser.
Secondary ID [1] 716 0
Nil
Universal Trial Number (UTN)
Trial acronym
LAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder (MDD) 3683 0
Condition category
Condition code
Mental Health 3848 3848 0 0
Depression
Alternative and Complementary Medicine 257379 257379 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Low Level Therapeutic Laser Acupuncture 1 Joule of laser per acupoint.

2. Five acupoints on the skin surface: LR14 (6th intercostal space midclavicular line, HT7 on medial edge of Left wrist crease, CV14 in epigastrium, LR8 at medial Left knee and KI3 at right medial ankle.

3.The laser acupuncture is applied 2 x a week for 4 weeks and then 1x a week for another 4 weeks.

4. Each laser session goes on for less than 5 minutes. 10 seconds per acupoint for 5 acupoints = 50 seconds

5. Subjects undergo the baseline functional magnetic resonance imaging (fMRI) once: after recruitment and before the start of the clinical study.
Intervention code [1] 3396 0
Treatment: Other
Comparator / control treatment
1. No laser as placebo. The laser unit is set for active or no laser with a flick switch. There is no sensation felt with the laser so the laser unit is on in placebo mode with no laser output at all.

2. The placebo laser will be adminstered on the five acupoints as described above on the 5 acupoints as administered in active laser acupuncture: LR14, CV14, HT7, LR8, KI3.

3. 12 placebo laser sessions lasting 50 seconds each as above in real laser: 2 x week for 4 weeks, then 1 x week for another 4 weeks.

4. 50 seconds in total per subject as in active laser as described above.
Control group
Placebo

Outcomes
Primary outcome [1] 4748 0
Hamilton Depression Score (HAM-D)
Timepoint [1] 4748 0
1. Pre laser
2. 4 weeks
3. 8 weeks (after last session of laser)
4. 1 month post laser acupuncture
5. 3 months post laser acupuncture
Primary outcome [2] 258290 0
QID-SR
Quick Depression Inventory Self Reporting
Timepoint [2] 258290 0
1. Pre laser at recruitment
2. After completion of laser sessions.
Secondary outcome [1] 8022 0
QIDS-CL
Quick Inventory Depression Scale -Clinician
Timepoint [1] 8022 0
1. At recruitment
2. After completion of laser sessions

Eligibility
Key inclusion criteria
1. Major unipolar depressive disorder meeting
Diagnostic and Statistical Manual of Mental
Disorders IVth version (DSM-IV) criteria
2. QIDS-SR score > 10
3. HAMILTON-D score > 14

4. Participants to be free of psychotropic drugs
and /or herbals at least 4 weeks prior to
entry into the study

5. Participants will provide informed consent to
the study and, where relevant, consent to
functional magnetic resonance imaging
(fMRI)
6. No other co interventions allowed.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dysthymia-chronic low mood
2. Depression of over 2 years duration
3. History of hypomania or mania
4. Psychosis
5. Substance abuse disorder
6. Use of psychotropic drugs within the last 4
weeks prior to entry
7. Use of mood altering herbs within 4 weeks
prior to entry
8. Known Central Nervous System lesions
9. Known uncontrolled endocrine disorders,
pregnancy or potential pregnancy
10. Active suicidal tendencies.

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 by advertisement, TV media release and letters to doctors and psychologists.
Randomisation schedule by computer program into real laser and placebo laser. Participants and treating Medical Acupuncturist/s blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation by computer program provided by statistician at BlackDog Institute, University of New South Wales.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
1.Participants who receive placebo laser will be invited to have real laser acupuncture at the end of their 8 weeks of laser acupuncture intervention.

2. The medical acupuncturist is allowed to add extra acupoints for intercurrent acute problems eg soft tissue strain from sporting injury, symptoms of coughs and colds. These additional acupoints are recorded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
3/07/2008
Date of last participant enrolment
Anticipated
31/03/2010
Actual
29/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3864 0
Charities/Societies/Foundations
Name [1] 3864 0
Thyne-Reid Foundation
Country [1] 3864 0
Australia
Funding source category [2] 256862 0
Charities/Societies/Foundations
Name [2] 256862 0
Black Dog Foundation
Country [2] 256862 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Dr Im Quah-Smith
School of Psychiatry
University of New South Wales
Hospital Rd
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 256144 0
Hospital
Name [1] 256144 0
Prince of Wales Hospital
Address [1] 256144 0
Prof Perminder Sachdev
Neuropsychiatric Institute NPI
Prince of Wales Hospital
Euroa Ctr
Barker Street
Randwick NSW 2031
Country [1] 256144 0
Australia
Other collaborator category [1] 413 0
Individual
Name [1] 413 0
Dr Mark Williams
Address [1] 413 0
Macquarie Centre for Cognitive Sciences MACCS
Macquarie University
North Ryde
NSW 2113
Country [1] 413 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5917 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 5917 0
Ethics committee country [1] 5917 0
Australia
Date submitted for ethics approval [1] 5917 0
16/10/2007
Approval date [1] 5917 0
05/02/2008
Ethics approval number [1] 5917 0
HREC 07258

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

Contacts
Principal investigator
Name 28927 0
Dr Im Quah-Smith
Address 28927 0
Roseville Wellness Group
3/32 Barcoo Street
Roseville
NSW 2069
Country 28927 0
Australia
Phone 28927 0
612 94174772
Fax 28927 0
Email 28927 0
[email protected]
Contact person for public queries
Name 12084 0
Dr Im Quah-Smith
Address 12084 0
Roseville Wellness Group
3/32 Barcoo Street
Roseville
NSW 2069
Country 12084 0
Australia
Phone 12084 0
612 94174772
Fax 12084 0
612 94169743
Email 12084 0
[email protected]
Contact person for scientific queries
Name 3012 0
Prof Perminder Sachdev
Address 3012 0
Centre for Healthy Brain Aging
CHeBA
Barker St
RANDWICK 2031
Country 3012 0
Australia
Phone 3012 0
612 9382 3763
Fax 3012 0
612 9382 3774
Email 3012 0
[email protected]

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.