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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00467402
First received: April 27, 2007
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.


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: Prevention
Official Title: A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to relapse, where relapse is defined by the occurrence of any one of the following: [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale total score ≥16 at two consecutive visits; [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
  • hospitalization due to depression; [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
  • suicide attempt or suicide; [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
  • discontinuation due to lack of efficacy according to Investigator judgment. [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who demonstrate clinical improvement at the end of the double-blind continuation phase, where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale. [ Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase ] [ Designated as safety issue: No ]
  • Proportion of patients experiencing relapse during the double-blind continuation phase. [ Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve remission at the end of the double-blind continuation phase, where remission is defined by a total score of ≤7 on the HAM-D. [ Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase ] [ Designated as safety issue: No ]
  • Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores. [ Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase ] [ Designated as safety issue: No ]

Enrollment: 644
Study Start Date: April 2007
Primary Completion Date: September 2009 (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:

  • Male and female adults, 18 through 70 years of age, inclusive
  • Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
  • A history of at least two previous episodes of Major Depression plus the current episode
  • Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline

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
  • Use of any psychoactive medication after the screening visit
  • Patients who have been previously treated with agomelatine
  • 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: NCT00467402

  Show 78 Study Locations
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00467402     History of Changes
Other Study ID Numbers: CAGO178A2304
Study First Received: April 27, 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:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
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 September 18, 2014