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Completed

NCT Number: NCT00467402

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Agomelatine

Drug

Placebo

Drug

Primary outcomes

  1. 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

  2. Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;

    Time frame: Primary efficacy variable is measured from randomization to relapse

  3. hospitalization due to depression;

    Time frame: Primary efficacy variable is measured from randomization to relapse

  4. suicide attempt or suicide;

    Time frame: Primary efficacy variable is measured from randomization to relapse

  5. discontinuation due to lack of efficacy according to Investigator judgment.

    Time frame: Primary efficacy variable is measured from randomization to relapse

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
First posted
Apr 30, 2007
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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