Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:

A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01156415
• Other study ID #: CAGO178C2399
• Status: Terminated
• Phase: Phase 3
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase.

Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study.

Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 837
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

Inclusion Criteria:

Key Inclusion Criteria Cohort I:

• Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.

• Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study).

• Female patients should continue to use effective contraception as defined in double-blind study protocol.

Inclusion Criteria:

Key Inclusion criteria Cohort II:

• Male and female adults, 18 through 70 years of age, inclusive.

• Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.

• Current episode =4 weeks.

• CGI-Severity score =4 at Screening and Baseline.

Exclusion Criteria:

Key Exclusion Criteria Cohort I:

• Concomitant use of fluvoxamine.

• Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator.

Exclusion Criteria:

Key Exclusion criteria Cohort II:

• History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.

• Any other current Axis I disorder other than MDD which is the focus of treatment.

• Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.

• Prior exposure to agomelatine.

• Female patients of childbearing potential who are not using effective contraception.

Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• AGO178

• AGO178

Locations

Country	Name	City	State
Puerto Rico	Centro de Investigacion Clinica Psiquiatrica	Ponce
Puerto Rico	Dharma Institute and Research Center	San Juan
Puerto Rico	INSPIRA Clinical Research	San Juan
United States	Neurological Associates Of Albany	Albany	New York
United States	Albuquerque Neuroscience	Albuquerque	New Mexico
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Clinical Studies	Altamonte Springs	Florida
United States	Millwood Hospital	Arlington	Texas
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Southwestern Research Institute	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Social Psychiatry Research, Inc./ SPRI	Brooklyn	New York
United States	Neuro Behavioral Clinical Research	Canton	Ohio
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Comprehensive Neuroscience	Cerritos	California
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	North Star Medical Research	Cleveland	Ohio
United States	The Ohio State Universtiy - Harding Hospital	Columbus	Ohio
United States	Arocha Research Center	Coral Gables	Florida
United States	CNS Clinical Research	Coral Springs	Florida
United States	ATP Clinical Research, Inc	Costa Mesa	California
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Western Affiliated Research Institute	Denver	Colorado
United States	InSite Clinical Research	DeSoto	Texas
United States	Sjs Clinical Research	Destin	Florida
United States	Michigan State University	East Lansing	Michigan
United States	Odyssey Research Services	Fargo	North Dakota
United States	Collaborative Neuroscience Network	Garden Grove	California
United States	Comprehensive Psychiatric Associates	Gladstone	Missouri
United States	Advanced Research Associates	Glendale	Arizona
United States	Pine Rest Christian Mental Health Services	Grand Rapids	Michigan
United States	Pharmquest	Greensboro	North Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Hawaii Clinical Research Center	Honolulu	Hawaii
United States	Bayou City Research Limited	Houston	Texas
United States	Claghorn Lesem Research Clinic, Inc.	Houston	Texas
United States	Texas Center for Drug Development	Houston	Texas
United States	CNS Healthcare	Jacksonville	Florida
United States	Joliet Center for Clinical Research	Joliet	Illinois
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Florida Clinical Research Center	Maitland	Florida
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Research Strategies of Memphis	Memphis	Tennessee
United States	Middlesex Hospital	Middletown	Connecticut
United States	Clinical Research Associates	Nashville	Tennessee
United States	Eastside Comprehensive Medical Service	New York	New York
United States	Medical & Behavior Health Research	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Deaconess Clinic Gateway	Newburgh	Indiana
United States	Pharmacology Research Institute	Newport Beach	California
United States	Cutting Edge Research	Oklahoma City	Oklahoma
United States	IPS Research	Oklahoma City	Oklahoma
United States	SP Research	Oklahoma City	Oklahoma
United States	Pacific Clinical Research Medical Group	Orange	California
United States	CNS Healthcare	Orlando	Florida
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Pharmasite Research	Pikesville	Maryland
United States	Robert Wood Johnson Medical School	Piscataway	New Jersey
United States	Quantum Lab. at N. Broward Memory Disorder Center	Pompano Beach	Florida
United States	Oregon Center for Clinical Investigations	Portland	Oregon
United States	Summit Research	Portland	Oregon
United States	Zarzar Psychiatric Associates	Raleigh	North Carolina
United States	Alliance Research Group, LLC	Richmond	Virginia
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Comprehensive NeuroScience, Inc.	Saint Petersburg	Florida
United States	Radiant Research	Salt Lake City	Utah
United States	University of Utah Mood Disorders Clinic	Salt Lake City	Utah
United States	CNRI-San Diego, LLC	San Diego	California
United States	University of California, San Diego Medical Center	San Diego	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	Southwest Health Ltd dba The Mollen Clinic	Scottsdale	Arizona
United States	Rush University Medical Center	Skokie	Illinois
United States	Miami Research Associates	South Miami	Florida
United States	Frontier Institute	Spokane	Washington
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Viking Clinical Research Center	Temecula	California
United States	Neurology & Neuroscience Center of Ohio	Toledo	Ohio
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Collaborative Neuroscience	Torrance	California
United States	Mount Auburn Medical Associates	Watertown	Massachusetts
United States	Independent Psychiatric Consultants	Waukesha	Wisconsin
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Coastal Research Associates	Weymouth	Massachusetts
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	CRI Worldwide	Willingboro	New Jersey
United States	Piedmont Medical Research Associates, Inc.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale		52 weeks
Secondary	Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale		Week 6, 8, 12, 28, 36 and 52
Secondary	Proportion of patients who demonstrate clinical improvement at Week 6,8,12, 28,36 and 52, where improvement is defined by a score of 1 or 2 on the CGI-I scale		Week 6, 8, 12, 28, 36 and 52
Secondary	Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52		Week 52
Secondary	Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52		Week 52

External Links

•   Click here for more information about this study:
•   Results for CAGO178C2399 from the Novartis Clinical Trials website