Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000601831
Ethics application status
Approved
Date submitted
12/03/2021
Date registered
20/05/2021
Date last updated
14/03/2023
Date data sharing statement initially provided
20/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Agomelatine in Depression: An Open-Label Study of Agomelatine in Adults with Major Depressive Disorder
Scientific title
Agomelatine in Depression: An Exploratory Open Label Study of the Neurobiological Effects of Agomelatine in Adults with Major Depressive Disorder
Secondary ID [1] 303494 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 320814 0
Condition category
Condition code
Mental Health 318638 318638 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive agomelatine, dosed once daily as a 25mg oral tablet for the duration of study (8 weeks).
Intervention code [1] 319783 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326668 0
Exploratory outcome looking at Neurobiological Effects using an EEG.
Timepoint [1] 326668 0
Endpoint evaluated at baseline and week 8.
Secondary outcome [1] 392319 0
N/A
Timepoint [1] 392319 0
N/A

Eligibility
Key inclusion criteria
1. Age/Sex:
• Male or female, aged 18 to <75 years old at the time of informed consent.

2. Diagnosis
• Major Depressive Disorder (MDD)

3. Severity
• Moderate or severe depression based on the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) depression criteria.

4. Treatment history
• Currently on an antidepressant

5. Biomarkers
• Agrees to, and is eligible for all biomarker assessments

6. Other:
• Fluent in English
• Ability to provide informed consent and complete all assessments independently.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age
• Aged 75 or older at the time of informed consent

2. Treatment
• Concurrent use of potent CYP1A2 inhibitors (e.g. fluvoxamine and ciprofloxacin)

3. Medical Conditions:
• Hepatic impairment (i.e. cirrhosis or active liver disease)
• Baseline serum transaminase levels exceed 3 times the upper limit of normal
• Pregnant or breastfeeding. If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception (e.g., oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception) or abstinence during the study, and for as long as they remain on sponsor provided agomelatine treatment.
• Severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks

4. Other:
• Concurrent or recent participation in any another research study aimed at treating mental illness.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Analyses will examine biological correlates and consequences of agomelatine treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/06/2021
Actual
7/06/2021
Date of last participant enrolment
Anticipated
15/10/2022
Actual
15/07/2022
Date of last data collection
Anticipated
15/12/2022
Actual
8/09/2022
Sample size
Target
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 18824 0
Westmead Hospital - Westmead
Recruitment hospital [2] 18825 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment hospital [3] 21097 0
Albert Road Clinic - Melbourne
Recruitment postcode(s) [1] 33275 0
2145 - Westmead
Recruitment postcode(s) [2] 33276 0
3004 - Melbourne
Recruitment postcode(s) [3] 35952 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 307912 0
Commercial sector/Industry
Name [1] 307912 0
Alto Neuroscience (Australia) Pty Ltd
Country [1] 307912 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alto Neuroscience (Australia) Pty Ltd
Address
Suite 5, 1st Floor, 200 Victoria Road, Drummoyne NSW 2047 Australia
Country
Australia
Secondary sponsor category [1] 308624 0
None
Name [1] 308624 0
Address [1] 308624 0
Country [1] 308624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307911 0
Western Sydney Local Health District HREC
Ethics committee address [1] 307911 0
Ethics committee country [1] 307911 0
Australia
Date submitted for ethics approval [1] 307911 0
03/11/2020
Approval date [1] 307911 0
25/11/2020
Ethics approval number [1] 307911 0
Research office File No: 6603
Ethics committee name [2] 309829 0
The Alfred Hospital Ethics Committee
Ethics committee address [2] 309829 0
Ethics committee country [2] 309829 0
Australia
Date submitted for ethics approval [2] 309829 0
25/02/2021
Approval date [2] 309829 0
03/05/2021
Ethics approval number [2] 309829 0
HREC/72941/Alfred-2021

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

Contacts
Principal investigator
Name 108898 0
Dr Amit Etkin
Address 108898 0
Alto Neuroscience Australia, PO Box 15 Paddington, Sydney 2021
Country 108898 0
Australia
Phone 108898 0
+61 2 9327 2654
Fax 108898 0
Email 108898 0
[email protected]
Contact person for public queries
Name 108899 0
Jessica Powell
Address 108899 0
Alto Neuroscience, 369 South San Antonio Rd., Los Altos, CA 94022
Country 108899 0
United States of America
Phone 108899 0
+61 2 9327 2654
Fax 108899 0
Email 108899 0
[email protected]
Contact person for scientific queries
Name 108900 0
Adam Savitz
Address 108900 0
Alto Neuroscience, Suite 5, 1st Floor, 200 Victoria Road, Drummoyne NSW 2047
Country 108900 0
Australia
Phone 108900 0
+61 2 9327 2654
Fax 108900 0
Email 108900 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.