Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00411099

Enrollment

508

Registered

2006-12-13

Start date

2006-12-31

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 assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.

Interventions

DRUGagomelatine

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

* Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria * HAM-D17 total score \> or = 22 at Screening and Baseline * CGI-Severity score \> or = 4 at Screening and Baseline * Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase

Exclusion criteria

* 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 * Concomitant psychotropic medication, including herbal preparations and melatonin * Psychotherapy of any type * Female patients of childbearing potential who are not using effective contraception Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)	8 weeks

Secondary

Measure	Time frame
To evaluate the proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale	8 weeks
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17	8 weeks
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8	8 weeks
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17	8 weeks
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8	8 weeks

Countries

Puerto Rico, United States

Outcome results

None listed

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