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

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: agomelatine; Drug: placebo

• Registration Number: NCT00411099
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Study First Posted: 2006-12-13
• Primary Completion: 2008-01
• Status Verified: 2012-05
• Disposition First Submitted: 2012-05-02
• Disposition First Submitted QC: 2012-05-02
• Disposition First Posted: 2012-05-04
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

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/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	agomelatine	-
3	placebo	-
2	agomelatine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇵🇷 Rio Piedras, Puerto Rico