A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)

An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00463242

Enrollment

501

Registered

2007-04-20

Start date

2007-03-31

Completion date

Unknown

Last updated

2020-12-23

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

Conditions

Major Depressive Disorder

Keywords

agomelatine, Major Depressive Disorder, MDD, depression

Brief summary

This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.

Interventions

DRUGAgomelatine

Either 25 mg or 50 mg agomelatine orally once daily

DRUGparoxetine

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male and female adults, 18 through 70 years of age, inclusive * Diagnosis of Major Depressive Disorder according to DSM-IV criteria * HAM-D17 total score \> or = 22 at Screening and Baseline

Exclusion criteria

* History of non-response to paroxetine * Patients who have been previously treated with agomelatine * History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder * Any current Axis I disorder other than major depressive disorder which is the focus of treatment * Substance or alcohol abuse in the last 30 days, dependence in the last 6 months * Use of any psychoactive medication after the screening visit * Female patients of childbearing potential who are not using effective contraception Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale	8 weeks

Secondary

Measure	Time frame
To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX).	8 weeks
Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8.	8 weeks
Proportion of patients with MDD who achieve remission,	8 weeks
Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).	8 weeks

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026