Effects of agomelatine on sleep electroencephalogram parameters compared to selective serotonin reuptake inhibitors in patients with major depressive disorder: a six-week randomised, double-blind parallel group study versus comparator, followed by a double-blind optional treatment extension period up to six months

"Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder. A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months."

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44737909

Enrollment

130

Registered

2007-06-22

Start date

2007-02-15

Completion date

Unknown

Last updated

2018-05-21

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

Conditions

Major Depressive Disorder Mental and Behavioural Disorders Depression

Interventions

Therapeutic doses of agomelatine versus therapeutic doses of SSRI.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 60 years 2. Male or female 3. Fulfilling Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV-TR) criteria for major depressive disorder

Exclusion criteria

Exclusion criteria: 1. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women 2. All types of depression other than major depressive disorder

Design outcomes

Primary

Measure	Time frame
Effects of agomelatine on sleep Electroencephalogram (EEG) parameters, corresponding to sleep efficiency index, compared to SSRI in patients with major depressive disorder.	—

Secondary

Measure	Time frame
1. Other sleep parameters 2. Subjective sleep parameters 3. Daytime performance 4. Evaluation of depression with the Hamilton rating scale for Depression (HAM-D) scale 5. Safety measured with adverse events, laboratory parameters, and Electrocardiogram (ECG) parameters	—

Countries

Australia, Austria, Brazil, Finland, France, Germany, Spain, Taiwan, United Kingdom

Outcome results

None listed

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