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

April 27, 2007
May 2, 2012
April 2007
September 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Time to relapse, where relapse is defined by the occurrence of any one of the following:
  • Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;
  • hospitalization due to depression;
  • suicide attempt or suicide;
  • discontinuation due to lack of efficacy according to Investigator judgment.
Complete list of historical versions of study NCT00467402 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
  • Proportion of patients experiencing relapse during the double-blind continuation phase.
  • 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.
  • Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores.
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Major Depressive Disorder
  • Drug: agomelatine
  • Drug: placebo
  • Experimental: 1
    Intervention: Drug: agomelatine
  • Experimental: 2
    Intervention: Drug: agomelatine
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
644
Not Provided
September 2009   (final data collection date for primary outcome measure)

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

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00467402
CAGO178A2304
Not Provided
Novartis
Novartis
Not Provided
Not Provided
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP