Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder.

Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder. An exploratory 6-week open, flexible dose, international multicentre, non comparative study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024191-25-DE

Enrollment

120

Registered

2012-02-08

Start date

2012-03-30

Completion date

Unknown

Last updated

2014-10-27

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

Conditions

Major Depressive Disorder MedDRA version: 17.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: VALDOXAN Product Name: S20098 Product Code: S20098 Pharmaceutical Form: Tablet INN or Proposed INN: AGOMELATINE CAS Number: 138112-76-2 Current Sponsor code: S20098 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Outpatients of both gender, age 18 to 60 included - Fulfilling DSM-IV-TR criteria for Major Depressive Disorder single or recurrent episode - Diagnosis documented using the brief structured interview MINI - Hamilton Depression Ratin Scale: HAM-D 17 items total score > or = 22 and sum of HAM-D item 5 "Insomnia: middle of the night" + item 6 "Insomnia early hours of the morning" > or = 3 - Requiring antidepressant treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Marked suicidal intent and/or known suicidal tendencies for the current episode according to the investigator's opinion - Any clinically relevant abnormality detected during the physical examination, ECG or laboratory test likely to interfere with the study conduct or evaluation - Women of childbearing potential without effective contraception method - Pregnant or breast-feeding women - Patients not able to read or to complete self-rating questionnaires - Hepatic impairment

Design outcomes

Primary

Measure	Time frame
Primary end point(s): No primary criterion has been defined for this exploratory study. The following criteria will be evaluated: - Circadian parameters - Depressive symptoms - Clinical benefit on morning condition, social functioning and daytime functioning - Safety criteria - Other assessments not specifically related to efficacy or safety;Main Objective: Assess the effect of agomelatine on the circadian rhythms in Major Depressive Disorder patients by evaluating circadian parameters.;Secondary Objective: Effects of agomelatine on depression and its acceptability;Timepoint(s) of evaluation of this end point: All over the study	—

Measure

Time frame

Primary end point(s): No primary criterion has been defined for this exploratory study. The following criteria will be evaluated: - Circadian parameters - Depressive symptoms - Clinical benefit on morning condition, social functioning and daytime functioning - Safety criteria - Other assessments not specifically related to efficacy or safety;Main Objective: Assess the effect of agomelatine on the circadian rhythms in Major Depressive Disorder patients by evaluating circadian parameters.;Secondary Objective: Effects of agomelatine on depression and its acceptability;Timepoint(s) of evaluation of this end point: All over the study

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Austria, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026