Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000856718
Ethics application status
Approved
Date submitted
30/07/2013
Date registered
2/08/2013
Date last updated
23/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Metformin for Mind and Metabolism
Scientific title
Metformin for Mind and Metabolism: The effect of metformin 2000mg/day on mood and cognition in adults with treatment resistant depression and abdominal obesity: a pilot randomized placebo controlled trial over 12 weeks.
Secondary ID [1] 282925 0
Nil
Universal Trial Number (UTN)
Trial acronym
The MMM study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 289742 0
Abdominal Obesity 289743 0
Condition category
Condition code
Mental Health 290073 290073 0 0
Depression
Diet and Nutrition 290107 290107 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin 2 x 500mg oral tablets twice daily for 12 weeks (total daily dose 2000mg). Adherence will be monitored by counting drug returns on a monthly basis.
Intervention code [1] 287627 0
Treatment: Drugs
Comparator / control treatment
Placebo (gelatine capsule filled with lactose powder) oral capsule taken twice daily for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 290126 0
severity of depression as assessed using the MADRS (Montgomery Asperg Depression Rating Scale)
Timepoint [1] 290126 0
12 weeks
Secondary outcome [1] 303978 0
change in cognition as measured by CogState (computer based cognitive testing)
Timepoint [1] 303978 0
12 weeks
Secondary outcome [2] 303979 0
change in weight as determined by using calibrated digital scales
Timepoint [2] 303979 0
12 weeks

Eligibility
Key inclusion criteria
adults aged 18-65
ongoing symptoms of depression (MADRS>10) despite at least 8 weeks on a stable dose of an antidepressant
adbominal obesity (waist circumference >88cm for women or 102cm for men)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
renal impairment (eGFR<60)
suicidal
psychotic disorders
diabetes mellitus
allergy to metformin, lactose or other component of metformin or placebo formulations

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2013
Actual
16/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287705 0
Charities/Societies/Foundations
Name [1] 287705 0
Preston and Loui Geduld Charitable Trust
Country [1] 287705 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Commercial Rd
Prahran
Melbourne VIC
3181
Country
Australia
Secondary sponsor category [1] 286435 0
None
Name [1] 286435 0
None
Address [1] 286435 0
Country [1] 286435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289662 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 289662 0
The Alfred Hospital
Commercial Rd
Prahran VIC
3181
Ethics committee country [1] 289662 0
Australia
Date submitted for ethics approval [1] 289662 0
31/07/2013
Approval date [1] 289662 0
20/09/2013
Ethics approval number [1] 289662 0
126/13
Ethics committee name [2] 293741 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 293741 0
Ethics committee country [2] 293741 0
Australia
Date submitted for ethics approval [2] 293741 0
Approval date [2] 293741 0
30/10/2013
Ethics approval number [2] 293741 0
CF13/3101 - 2013001644

Summary
Brief summary
Metformin is a medication originally derived from French Lilac which has been used to treat diabetes for over 50 years. The aim of this study is to see whether metformin can improve mood and memory in people who have depression and obesity. We will recruit 30 adults who feel depressed despite currently taking an antidepressant medication and who also have a large waist measurement (more than 88cm for women and 102cm for men). The study will last for 12 weeks. Participants will be randomized to either metformin 1000mg twice per day with food or placebo. At the beginning and the end of the study mood will be rated by self-report and by the doctor’s impression. Memory will be measured using a series of computer based tests, similar to playing simple computer games. The hope is that metformin will help obese adults with depression by reducing levels of the hormone insulin as well as markers of inflammation, within the brain, thereby improving mood.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41846 0
Dr Roisin Worsley
Address 41846 0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne VIC 3004
Country 41846 0
Australia
Phone 41846 0
+61 3 9076 6564
Fax 41846 0
Email 41846 0
[email protected]
Contact person for public queries
Name 41847 0
Dr Roisin Worsley
Address 41847 0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne VIC 3004
Country 41847 0
Australia
Phone 41847 0
+61 3 9076 6564
Fax 41847 0
Email 41847 0
[email protected]
Contact person for scientific queries
Name 41848 0
Dr Roisin Worsley
Address 41848 0
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne VIC 3004
Country 41848 0
Australia
Phone 41848 0
+61 3 9076 6564
Fax 41848 0
Email 41848 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
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