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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

agomelatine

placebo

About this trial

This is an interventional prevention trial for Major Depressive Disorder focused on measuring agomelatine, Major Depressive Disorder, MDD, depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT00467402

First Posted

April 27, 2007

Last Updated

December 15, 2020

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00467402

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

agomelatine, Major Depressive Disorder, MDD, depression

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

644 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

agomelatine

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Time to relapse, where relapse is defined by the occurrence of any one of the following:

Time Frame