Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000574640
Ethics application status
Approved
Date submitted
26/05/2014
Date registered
29/05/2014
Date last updated
27/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Magnesium supplements for the treatment of resistant depression
Scientific title
The effect of 1600mg daily dosage of Magnesium supplementation as an augment to SSRI medication on the clinical symptoms of patients with treatment resistant depression: a pilot study
Secondary ID [1] 284662 0
Nil Known
Universal Trial Number (UTN)
U1111-1157-2937
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 291985 0
Condition category
Condition code
Mental Health 292328 292328 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
magnesium oral tablet supplement @1600mg daily in divided doses morning and evening with food for 8 weeks, in addition to prescribed SSRI medication

participants recruited with a history of non-response to standard treatment


pilot only target is n=10

dosage log provided for participants with weekly phone follow up to ensure dosage fidelity
Intervention code [1] 289442 0
Treatment: Drugs
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292198 0
Beck Depression Inventory (BDI) <10
Timepoint [1] 292198 0
BDI intake, which is the baseline measurement point pre-intervention; time point 1 which is the end of the first week, and the end of week 8 (endpoint)

Primary outcome [2] 292199 0
DAS Depression and anxiety scale <20
Timepoint [2] 292199 0
intake, which is the baseline measurement point pre-intervention; and the end of week 8 (endpoint)
Primary outcome [3] 292200 0
Edinburgh mood scale (EMS) higher scores indicate improved mood
Timepoint [3] 292200 0
intake, which is the baseline measurement point pre-intervention; and the end of week 8 (endpoint)
Secondary outcome [1] 308401 0
Outcome Questionnaire OQ45 function scale <63
Timepoint [1] 308401 0
OQ45; intake, which is the baseline measurement point pre-intervention; time point 1 which is the end of the first week, and then weekly measurement intervals until the end of week 8 (endpoint)
Secondary outcome [2] 308402 0
Quality of Life short form (QOL) higher scores indicate higher perceived quality of life
Timepoint [2] 308402 0
For QOL short form: intake, which is the baseline measurement point pre-intervention; and the end of week 8 (endpoint)

Eligibility
Key inclusion criteria
Participants should:
1. Be depressed, while taking SSRI antidepressant medication as prescribed by their doctor
2. Currently be under the management of a medical practitioner e.g. family doctor or a psychiatrist
3. Have a history of depression that has not responded well to medication, with at least 2 previous episodes
4. Be over 18 years of age and have the capacity to provide informed consent
5. Have the willingness and ability to comply with assessment protocols of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Resistant depression not being the primary diagnosis
2. current substance misuse
3. other psychiatric disorder as primary diagnosis
4. active suicidality
5. not able to understand or conform to study requirements
6. Subject to a mental health or guardianship order

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants with demonstrated non-response to a variety of standard treatment (meds) will be recruited from the community. The single group condition will not involve concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
non-randomised single group trial
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
repeated measures

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2014
Actual
9/06/2014
Date of last participant enrolment
Anticipated
31/07/2014
Actual
29/08/2014
Date of last data collection
Anticipated
Actual
15/01/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8139 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 289291 0
University
Name [1] 289291 0
The University of Queensland
Country [1] 289291 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Mayne Medical School
288 Herston Road, Herston
Brisbane, QLD, 4006 Australia
Country
Australia
Secondary sponsor category [1] 287961 0
None
Name [1] 287961 0
Address [1] 287961 0
Country [1] 287961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291056 0
Medical Research Ethics Committee
Ethics committee address [1] 291056 0
Human Ethics, Research Management Office
UQ Research and Innovation Cumbrae-Stewart Building
University of Queenlsand, St Lucia 4067
Ethics committee country [1] 291056 0
Australia
Date submitted for ethics approval [1] 291056 0
Approval date [1] 291056 0
21/03/2014
Ethics approval number [1] 291056 0
2012000647

Summary
Brief summary
This study examines the role of Magnesium supplementation in depression that is resistant to standard treatment. 10 participants who have a confirmed history of treatment non-response while on Medication will be recruited into this small pilot study.

participants will take a 1600mg a day divided Magnesium dose in addition to standard medication treatment for a maximum of 8 weeks following a standard protocol in which participants will be subject to pre and post clinical symptom measures.

this study aims to provide a preliminary investigation of the value of Magnesium supplement adjuvant treatment for resistant depression.
Trial website
Trial related presentations / publications
Bambling M, Vitetta L, Edwards S, & Cousins S. (2015) S-adenosylmethionine (SAMe) and Magnesium Orotate as adjunctives to SSRIs in sub-optimal treatment response of depression in adults; a pilot study. Adv Integr Med (2015), http://dx.doi.org/10.1016/j.aimed.2015.04.003
Public notes
Study completed

Contacts
Principal investigator
Name 48678 0
Dr Matthew Bambling
Address 48678 0
The University of Queensland
Mayne Medical School
288 Herston Road, Herston
Brisbane, QLD, 4006 Australia
Country 48678 0
Australia
Phone 48678 0
+61 7 3346 4780
Fax 48678 0
Email 48678 0
[email protected]
Contact person for public queries
Name 48679 0
Dr Matthew Bambling
Address 48679 0
The University of Queensland
Mayne Medical School
288 Herston Road, Herston
Brisbane, QLD, 4006 Australia
Country 48679 0
Australia
Phone 48679 0
+61 7 3346 4780
Fax 48679 0
Email 48679 0
[email protected]
Contact person for scientific queries
Name 48680 0
Dr Matthew Bambling
Address 48680 0
The University of Queensland
Mayne Medical School
288 Herston Road, Herston
Brisbane, QLD, 4006 Australia
Country 48680 0
Australia
Phone 48680 0
+61 7 3346 4780
Fax 48680 0
Email 48680 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.