Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001150538
Ethics application status
Approved
Date submitted
16/01/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Creatine and Exercise as a Novel Treatment Strategy for Depression in Adults Aged 18-39 Years
Scientific title
Creatine and Exercise as a Novel Treatment Strategy for Depression in Adults Aged 18-39 Years
Secondary ID [1] 311307 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 332555 0
Condition category
Condition code
Mental Health 329246 329246 0 0
Depression
Physical Medicine / Rehabilitation 331593 331593 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two separate treatment arms:

Treatment Arm One: 10g Creatine per day for 6 weeks; oral (diluted in flavored cordial in an opaque bottle) without resistance training

Treatment Arm Two: 10g Creatine per day for 6 weeks; oral (diluted in flavored cordial in an opaque bottle) with resistance training as detailed below.

6 weeks resistance training, 3 times per week with at least 48 hours recovery; Whole-Body program

All exercise sessions will be supervised by selected research investigators that are first aid-trained and have previously completed their Certificate 3 and 4 in Fitness
Sessions will be one-on-one at the Swinburne University gym
Exercise intensities will range from 50-80% of a pre-determined maximum strength test and will be performed at an intensity level aiming for 7-9 out of 10 on a Borg Scale
Participants will complete three sessions per week for six weeks; each session will last between 35-45 minutes including a warm-up and warm-down.
Adherence will be monitored by counting the number of sessions completed during the six period and compared to the target of 18 sessions throughout the entire intervention.
Intervention code [1] 327752 0
Treatment: Other
Comparator / control treatment
The control/comparator group will undertake 6 weeks resistance training (3 times per week with at least 48 hours recovery; Whole-Body program; exactly the same program as detailed above) as well as receive 10g Maltodextrin per day for 6 weeks (oral; diluted in flavored cordial in an opaque bottle).
Control group
Placebo

Outcomes
Primary outcome [1] 337101 0
Depression
Timepoint [1] 337101 0
Pre-intervention (0 weeks); Post-intervention (6 weeks post intervention commencement)
Primary outcome [2] 339332 0
Depression
Timepoint [2] 339332 0
Pre-intervention (0 weeks); Post-intervention (6 weeks post intervention commencement)
Secondary outcome [1] 430717 0
Muscle Strength
Timepoint [1] 430717 0
Pre-intervention (0 weeks); Post-intervention (6 weeks post intervention commencement)
Secondary outcome [2] 430718 0
Circulating levels of Brain Derived Neutrophic Factor (BDNF)
Timepoint [2] 430718 0
Pre-intervention (0 weeks); Post-intervention (6 weeks post intervention commencement)

Eligibility
Key inclusion criteria
- Aged 18-39 years.
- Mild-moderate depression severity (scoring between 5-19 on the Patient Health Questionnaire-9, PHQ-9)
- Body mass index (BMI) is between 18.5-29.9 kg/m².
- Sedentary (less than 150 min/week exercise/ physical activity)
- Not involved in a structured exercise program involving more than 2 exercise sessions per week in the last 6 months
Minimum age
18 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Hazardous alcohol or tobacco use using the AUDIT Alcohol Screening Tool
- No current or previous use of creatine supplements
- Physically active (greater than 150 min/week exercise/ physical activity)
- Serious somatic disorder based on a previous diagnosis from a Medical Doctor
- Psychiatric treatment
- Moderately severe and severe depression (PHQ-9>14 or >20 respectively).
- Body mass index (BMI) above 29.9 kg/m²
- Asthma
- Any current or history of respiratory or cardiac conditions
- Diabetes
- Pre-existing renal disease or proteinuria on baseline urinalysis testing
- History of creatinine hypersensitivity
- Concomitant treatment with antiepileptic or antipsychotic medications
- Neurological or psychiatric disorder
- Clinically significant suicidal or homicidal risk

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2024
Actual
Date of last participant enrolment
Anticipated
18/08/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315560 0
Charities/Societies/Foundations
Name [1] 315560 0
Barber Dicker Sciences Brain Sciences Foundation
Country [1] 315560 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
John Street, Hawthorn, 3122
Country
Australia
Secondary sponsor category [1] 317679 0
None
Name [1] 317679 0
Address [1] 317679 0
Country [1] 317679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314459 0
Swinburne Human Research Ethics Committee
Ethics committee address [1] 314459 0
Ethics committee country [1] 314459 0
Australia
Date submitted for ethics approval [1] 314459 0
30/01/2024
Approval date [1] 314459 0
25/07/2024
Ethics approval number [1] 314459 0
Ethics committee name [2] 316092 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [2] 316092 0
Ethics committee country [2] 316092 0
Australia
Date submitted for ethics approval [2] 316092 0
30/01/2024
Approval date [2] 316092 0
25/07/2024
Ethics approval number [2] 316092 0

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

Contacts
Principal investigator
Name 131658 0
Dr Donny Camera
Address 131658 0
Swinburne University; Department of Health and Biostatistics; Room SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 131658 0
Australia
Phone 131658 0
+61 403166127
Fax 131658 0
Email 131658 0
[email protected]
Contact person for public queries
Name 131659 0
Donny Camera
Address 131659 0
Swinburne University; Department of Health and Biostatistics; Room SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 131659 0
Australia
Phone 131659 0
+61 403166127
Fax 131659 0
Email 131659 0
[email protected]
Contact person for scientific queries
Name 131660 0
Donny Camera
Address 131660 0
Swinburne University; Department of Health and Biostatistics; Room SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 131660 0
Australia
Phone 131660 0
+61 403166127
Fax 131660 0
Email 131660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.