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)

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Agomelatine
  • Either 25 mg or 50 mg agomelatine orally once daily
• Drug: paroxetine
• Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Agomelatine
  • Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began.
• Active Comparator: 2
• Placebo Comparator: 3

Primary Measures

• Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• 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).
  • Time Frame: 8 weeks
    Safety Issue?: No
• 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.
  • Time Frame: 8 weeks
    Safety Issue?: No
• Proportion of patients with MDD who achieve remission,
  • Time Frame: 8 weeks
    Safety Issue?: No
• Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).
  • Time Frame: 8 weeks
    Safety Issue?: No

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/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00463242

Study ID Number: CAGO178A2303

ClinicalTrials.gov Identifier: NCT00463242

Health Authority: United States: Food and Drug Administration