Agomelatine in Depression: An Open-Label Study of Agomelatine in Adults with Major Depressive Disorder

Phase 4

Completed

• Conditions: Major Depressive Disorder; Mental Health - Depression

• Registration Number: ACTRN12621000601831
• Lead Sponsor: Alto Neuroscience (Australia) Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Study Completion: 2022-09-08
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exploratory outcome looking at Neurobiological Effects using an EEG.[Endpoint evaluated at baseline and week 8.]

Secondary Outcome Measures

Name	Time	Method
/A[N/A]