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)
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT00463242
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 placebo - 2 paroxetine - Agomelatine 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.
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale 8 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Investigative Site
🇵🇷Hato Rey, Puerto Rico