Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000499482
Ethics application status
Approved
Date submitted
19/09/2007
Date registered
28/09/2007
Date last updated
28/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture and major depressive disorder: is Traditional Chinese Medicine pattern differentiation necessary?
Scientific title
Acupuncture and major depressive disorder: is pattern differentiation necessary?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 2382 0
Condition category
Condition code
Mental Health 2486 2486 0 0
Depression
Alternative and Complementary Medicine 2487 2487 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a 0.25 x 30mm needle, acupuncture will be applied to the points LR14 in the sixth intercostal space, PC6 on the forearm and LR3 on the foot as a standard treatment protocol. There will be another additional point added for three variations to the standard "Liver qi" pattern. For subjects with "Liver qi stasis" alone, the point GB34 on the knee will be added. Where subjects exhibit "Liver qi statis with heat" the point LR8 on the knee will be added. If the subject exhibits "Liver qi invading earth", the point SP6 near the ankle will be added. Consequnelty there will be four points used for any one of three presenting Liver patterns. Once placed, a "de qi" sensation shall be obtained and the needles left in situ for 20 minutes.
Intervention code [1] 2107 0
Treatment: Other
Comparator / control treatment
Wait-listed for 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 3384 0
The Diagnostic and Statistical Manual of Mental Disease version 4 (DSM IV) is used to measure the extent of depression (mild, moderate, severe under the DSM IV classification of major depression) and exclude other mental illnesses eg. bi-polar, psychotic episodes etc that would otherwise exclude the subject from the trial.
Timepoint [1] 3384 0
The initial interview using the DSM IV is undertaken as part of the recruitment (ie prior to intervention). If a subject is accepted into the trial, they complete the series of questionaries and intervention begins within 1 week. Subjects are also measured against DSM IV criteria post intervention immediately after their last treatment and again 8 weeks later at a follow up interview.
Secondary outcome [1] 5614 0
Beck Depression Inventory (BDI-II)
Timepoint [1] 5614 0
For treatment group - pre-treatment, post-treatment (8 weeks) and follow up (8 weeks after final treatment)

wait-list control group - at initial interview, pre-treatment (8 weeks after initial interview), post treatment (8 weeks) and follow up (8 weeks after final treatment)
Secondary outcome [2] 5615 0
Hamilton Depression Scale
Timepoint [2] 5615 0
For treatment group - pre-treatment, post-treatment (8 weeks) and follow up (8 weeks after final treatment)

wait-list control group - at initial interview, pre-treatment (8 weeks after initial interview), post treatment (8 weeks) and follow up (8 weeks after final treatment)
Secondary outcome [3] 5616 0
Speilberger State and Trait Anxiety Index (STAI Y1 and Y2)
Timepoint [3] 5616 0
For treatment group - pre-treatment, post-treatment (8 weeks) and follow up (8 weeks after final treatment)

wait-list control group - at initial interview, pre-treatment (8 weeks after initial interview), post treatment (8 weeks) and follow up (8 weeks after final treatment)
Secondary outcome [4] 5617 0
SCL-90-R (Symptom Checklist)
Timepoint [4] 5617 0
For treatment group - pre-treatment, post-treatment (8 weeks) and follow up (8 weeks after final treatment)

wait-list control group - at initial interview, pre-treatment (8 weeks after initial interview), post treatment (8 weeks) and follow up (8 weeks after final treatment)

Eligibility
Key inclusion criteria
Patients suffering mild to moderate depression as defined by the DSM IV.

Patients must be taking SSRI (selective serotonin re-uptake inhibitors) drugs and maintain their therapeutic realtionship with their GP/Psychiatrist.

Patients must maintain their SSRI therapy throughout the trial.

Patients must present with the Chinese Medical diagnostic pattern of "Liver Qi Stagnation".
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suicidal ideation, bipolar disorder, other serious mental health disorders as identified by the DSM IV as not falling into the classification of major depression.

Patients not on drugs or on drugs other than SSRIs.

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)
Subjects are self identifying/selecting. An initial interview is undertaken using the DSM IV to determine if the subject qualifies as suffering from major depression and does not exhibit any conditions relating to the exclusion criteria. Subjects are screened to ensure they are taking the correct drugs (SSRIs) and fit the Chinese medical pattern diagnosis of "liver qi stagnation". If the subject qualifies they are randomly allocated to either a treatment or wait-list control group by selecting a coloured bead from an opaque jar. Allocation is concealed as the interviewer is unaware as to which group the subject will be allocated until after the subject qualifies for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation based on selecting a coloured bead from an opaque jar (red beads = treatment group, green bead = wait-listed group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Individuals intially assigned to the wait-list are not informed that they have been wait-listed. They are tested at the intial interview and again 8 weeks later prior to commencement of the treatment. They are informed of their allocation to the wait-list at the conclusion of the trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 438 0
2000

Funding & Sponsors
Funding source category [1] 2633 0
University
Name [1] 2633 0
University of Technology, Sydney
Country [1] 2633 0
Australia
Primary sponsor type
University
Name
Dr Peter Meier
Address
MMB/Science
PO Box 123
Broadway 2007
NSW
Country
Australia
Secondary sponsor category [1] 2381 0
University
Name [1] 2381 0
Kirk Wilson
Address [1] 2381 0
MMB/Science
PO Box 123
Broadway 2007
NSW
Country [1] 2381 0
Australia
Other collaborator category [1] 46 0
University
Name [1] 46 0
Professor Ashley Craig
Address [1] 46 0
MMB/Science
PO Box 123
Broadway 2007
NSW
Country [1] 46 0
Australia
Other collaborator category [2] 47 0
University
Name [2] 47 0
Adjunct Professor Carole Rogers
Address [2] 47 0
MMB/Science
PO Box 123
Broadway 2007
NSW
Country [2] 47 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4555 0
University of Technology, Sydney Human Research Ethics Committee
Ethics committee address [1] 4555 0
PO Box 123
Broadway 2007
NSW
Ethics committee country [1] 4555 0
Australia
Date submitted for ethics approval [1] 4555 0
15/02/2007
Approval date [1] 4555 0
07/05/2007
Ethics approval number [1] 4555 0
UTS HREC 2007-028A

Summary
Brief summary
The aim of this study is to develop and test a rigorous acupuncture study design that will determine if acupuncture has a significant therapeutic effect in the treatment of depression. This will increase the understanding of how acupuncture can be effectively used as an adjunct therapy to treat depression and may lead to reduced drug dependency and side effects for patients. Subjects will need to be medically diagnosed as having major depression and be taking serotonin uptake inhibitors (prescribed medication). They will also be screened for the Traditional Chinese Medicine (TCM) diagnostic pattern of liver qi stagnation. Subjects will be treated with acupuncture and the outcomes of the treatment assessed using standard questionnaire/assessment tools.
Trial website
http://www.depressionacupuncturetrial.com/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28060 0
Address 28060 0
Country 28060 0
Phone 28060 0
Fax 28060 0
Email 28060 0
Contact person for public queries
Name 11217 0
Kirk Wilson
Address 11217 0
Meridian Healing Centre
Suite 6, Level 10
Dymocks Building
428 George ST
Sydney 2000
Country 11217 0
Australia
Phone 11217 0
+61 2 9231 3377
Fax 11217 0
Email 11217 0
[email protected]
Contact person for scientific queries
Name 2145 0
Peter Meier
Address 2145 0
MMB/Science
PO Box 123
Broadway 2007
NSW
Country 2145 0
Australia
Phone 2145 0
+61 2 9514 7858
Fax 2145 0
Email 2145 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

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