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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: December 11, 2006
Last updated: May 2, 2012
Last verified: May 2012
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.

Condition Intervention Phase
Major Depressive Disorder (MDD) Drug: agomelatine Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 (CAGO178A2302E)

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 8 weeks ]
  • To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8 [ Time Frame: 8 weeks ]

Enrollment: 503
Study Start Date: December 2006
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: agomelatine
Experimental: 2 Drug: agomelatine
Placebo Comparator: 3 Drug: placebo


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  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 identifier: NCT00411242

  Show 51 Study Locations
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00411242     History of Changes
Other Study ID Numbers: CAGO178A2302
Study First Received: December 11, 2006
Last Updated: May 2, 2012

Keywords provided by Novartis:
agomelatine, major depressive disorder, MDD, depression

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 19, 2017