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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00411099
First received: December 11, 2006
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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
Drug: agomelatine
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, 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 (CAGO178A2301E)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 508
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411099

  Show 44 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00411099     History of Changes
Other Study ID Numbers: CAGO178A2301
Study First Received: December 11, 2006
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:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014