Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00463242
First received: April 19, 2007
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Agomelatine
Drug: paroxetine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Proportion of patients with MDD who achieve remission, [ Time Frame: 8 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: March 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Agomelatine
Either 25 mg or 50 mg agomelatine orally once daily
Active Comparator: 2 Drug: paroxetine
Other Name: Paxil
Placebo Comparator: 3 Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463242

  Show 47 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00463242     History of Changes
Other Study ID Numbers: CAGO178A2303
Study First Received: April 19, 2007
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
agomelatine, Major Depressive Disorder, MDD, depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Paroxetine
S 20098
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014