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

NCT00467402 | Completed Phase 3

• 1 other identifier: CAGO178A2304
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 78

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.

Conditions

Major Depressive Disorder

Keywords

agomelatine, Major Depressive Disorder, MDD, depression

Outcome Measures

Primary Outcomes (5)

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

  Primary efficacy variable is measured from randomization to relapse

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

  Primary efficacy variable is measured from randomization to relapse

• hospitalization due to depression;

  Primary efficacy variable is measured from randomization to relapse

• suicide attempt or suicide;

  Primary efficacy variable is measured from randomization to relapse

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

  Primary efficacy variable is measured from randomization to relapse

Secondary Outcomes (4)

• 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.

  Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase

• Proportion of patients experiencing relapse during the double-blind continuation phase.

  Secondary efficacy variables will be measured from randomization to the end of 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.

  Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase

• Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores.

  Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase

Study Arms (3)

1

EXPERIMENTAL

Drug: agomelatine

2

EXPERIMENTAL

Drug: agomelatine

3

PLACEBO COMPARATOR

Drug: placebo

Interventions

agomelatine DRUG

1; 2

placebo DRUG

3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (78)

Novartis Investigative Site

Birmingham, Alabama, 35226, United States

Location

Novartis Investigative Site

Peoria, Arizona, 85381, United States

Location

Novartis Investigative Site

Tucson, Arizona, 85724, United States

Location

Novartis Investigative Site

Beverly Hills, California, 90210, United States

Location

Novartis Investigative Site

Costa Mesa, California, 92626, United States

Location

Novartis Investigative Site

Encino, California, 91316, United States

Location

Novartis Investigative Site

Glendale, California, 91206, United States

Location

Novartis Investigative Site

Los Angeles, California, 90024, United States

Location

Novartis Investigative Site

Newport Beach, California, 92660, United States

Location

Novartis Investigative Site

Oceanside, California, 92056, United States

Location

Novartis Investigative Site

Sacramento, California, 95817, United States

Location

Novartis Investigative Site

Sherman Oaks, California, 91403, United States

Location

Novartis Investigative Site

Temecula, California, 92591, United States

Location

Novartis Investigative Site

Wheat Ridge, Colorado, 80033, United States

Location

Novartis Investigative Site

Bradenton, Florida, 34208, United States

Location

Novartis Investigative Site

Coral Springs, Florida, 33065, United States

Location

Novartis Investigative Site

Fort Myers, Florida, 33912, United States

Location

Novartis Investigative Site

Gainesville, Florida, 32607, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32216, United States

Location

Novartis Investigative Site

St. Petersburg, Florida, 33702, United States

Location

Novartis Investigative Site

Venice, Florida, 34285, United States

Location

Novartis Investigative Site

West Palm Beach, Florida, 33407, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30328, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60611, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60640, United States

Location

Novartis Investigative Site

Libertyville, Illinois, 60048, United States

Location

Novartis Investigative Site

Overland Park, Kansas, 66211, United States

Location

Novartis Investigative Site

Topeka, Kansas, 66606, United States

Location

Novartis Investigative Site

New Orleans, Louisiana, 70114, United States

Location

Novartis Investigative Site

Rockville, Maryland, 20852, United States

Location

Novartis Investigative Site

Towson, Maryland, 21204, United States

Location

Novartis Investigative Site

Towson, Maryland, 85724, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02135, United States

Location

Novartis Investigative Site

Braintree, Massachusetts, 02184, United States

Location

Novartis Investigative Site

Worcester, Massachusetts, 01605, United States

Location

Novartis Investigative Site

Farmington Hills, Michigan, 48336, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, 55454, United States

Location

Novartis Investigative Site

Kansas City, Missouri, 64111, United States

Location

Novartis Investigative Site

Kansas City, Missouri, 66160, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63033, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63044, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63118, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 68198, United States

Location

Novartis Investigative Site

Newark, New Jersey, 07103, United States

Location

Novartis Investigative Site

Albuquerque, New Mexico, 87102, United States

Location

Novartis Investigative Site

Buffalo, New York, 14215, United States

Location

Novartis Investigative Site

New York, New York, 10021, United States

Location

Novartis Investigative Site

New York, New York, 10029, United States

Location

Novartis Investigative Site

The Bronx, New York, 10467, United States

Location

Novartis Investigative Site

Chapel Hill, North Carolina, 27599, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27609, United States

Location

Novartis Investigative Site

Cleveland, Ohio, 44195, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43210, United States

Location

Novartis Investigative Site

Toledo, Ohio, 43623, United States

Location

Novartis Investigative Site

Portland, Oregon, 97210, United States

Location

Novartis Investigative Site

Portland, Oregon, 97239, United States

Location

Novartis Investigative Site

Rhododendron, Oregon, 97049, United States

Location

Novartis Investigative Site

Allentown, Pennsylvania, 18104, United States

Location

Novartis Investigative Site

Lansdale, Pennsylvania, 19446, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19139, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15238, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29412, United States

Location

Novartis Investigative Site

Memphis, Tennessee, 38119, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37212, United States

Location

Novartis Investigative Site

Austin, Texas, 78754, United States

Location

Novartis Investigative Site

Austin, Texas, 78756, United States

Location

Novartis Investigative Site

DeSoto, Texas, 75115, United States

Location

Novartis Investigative Site

Houston, Texas, 77007, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Houston, Texas, 77042, United States

Location

Novartis Investigative Site

Lake Jackson, Texas, 77566, United States

Location

Novartis Investigative Site

Richmond, Virginia, 23230, United States

Location

Novartis Investigative Site

Virginia Beach, Virginia, 23230, United States

Location

Novartis Investigative Site

Edmonds, Washington, 98026, United States

Location

Novartis Investigative Site

Seattle, Washington, 98104, United States

Location

Novartis Investigative Site

Milwaukee, Wisconsin, 53226, United States

Location

Novartis Investigative Site

West Allis, Wisconsin, 53227, United States

Location

Related Links

• Results for CAGO178A2304 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

agomelatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2009
• Last Updated: December 23, 2020

Record last verified: 2012-05

Locations

US (78)