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

Agomelatine in Depression: An Exploratory Open Label Study of the Neurobiological Effects of Agomelatine in Adults with Major Depressive Disorder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000601831

Acronym

N/A

Enrollment

Registered

2021-05-20

Start date

2021-06-07

Completion date

2022-07-15

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is an open-label study of adjunctive treatment with agomelatine in adults with major depressive disorder. This study aims to understand the biological correlates and consequences of agomelatine treatment.

Interventions

All participants will receive agomelatine, dosed once daily as a 25mg oral tablet for the duration of study (8 weeks).

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 74 Years

Healthy volunteers

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.

Outcome results