Clinical trial NCT01156415: Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: agomelatine
Major Depressive Disorder
MDD
depression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 837
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale
timeFrame: 52 weeks
Secondary outcomes:
measure: Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale
timeFrame: Week 6, 8, 12, 28, 36 and 52
measure: 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
timeFrame: Week 6, 8, 12, 28, 36 and 52
measure: Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52
timeFrame: Week 52
measure: Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: Scottsdale
country: United States
facility: Southwest Health Ltd dba The Mollen Clinic
state: Arizona
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Beverly Hills
country: United States
facility: Southwestern Research Institute
state: California
city: Cerritos
country: United States
facility: Comprehensive Neuroscience
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: San Diego
country: United States
facility: CNRI-San Diego, LLC
state: California
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Center
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Middletown
country: United States
facility: Middlesex Hospital
state: Connecticut
city: Altamonte Springs
country: United States
facility: Clinical Studies
state: Florida
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Coral Gables
country: United States
facility: Arocha Research Center
state: Florida
city: Coral Springs
country: United States
facility: CNS Clinical Research
state: Florida
city: Destin
country: United States
facility: Sjs Clinical Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Lab. at N. Broward Memory Disorder Center
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Clinical Research Center
state: Hawaii
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Joliet
country: United States
facility: Joliet Center for Clinical Research
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Skokie
country: United States
facility: Rush University Medical Center
state: Illinois
city: Newburgh
country: United States
facility: Deaconess Clinic Gateway
state: Indiana
city: Pikesville
country: United States
facility: Pharmasite Research
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Mount Auburn Medical Associates
state: Massachusetts
city: Weymouth
country: United States
facility: Coastal Research Associates
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Grand Rapids
country: United States
facility: Pine Rest Christian Mental Health Services
state: Michigan
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Gladstone
country: United States
facility: Comprehensive Psychiatric Associates
state: Missouri
city: Piscataway
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Willingboro
country: United States
facility: CRI Worldwide
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience
state: New Mexico
city: Albany
country: United States
facility: Neurological Associates Of Albany
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Social Psychiatry Research, Inc./ SPRI
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Service
state: New York
city: New York
country: United States
facility: Medical & Behavior Health Research
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Raleigh
country: United States
facility: Zarzar Psychiatric Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates, Inc.
state: North Carolina
city: Fargo
country: United States
facility: Odyssey Research Services
state: North Dakota
city: Canton
country: United States
facility: Neuro Behavioral Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: North Star Medical Research
state: Ohio
city: Columbus
country: United States
facility: The Ohio State Universtiy - Harding Hospital
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: SP Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations
state: Oregon
city: Portland
country: United States
facility: Summit Research
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Memphis
country: United States
facility: Research Strategies of Memphis
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Arlington
country: United States
facility: Millwood Hospital
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Bayou City Research Limited
state: Texas
city: Houston
country: United States
facility: Claghorn Lesem Research Clinic, Inc.
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Mood Disorders Clinic
state: Utah
city: Richmond
country: United States
facility: Alliance Research Group, LLC
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Frontier Institute
state: Washington
city: Waukesha
country: United States
facility: Independent Psychiatric Consultants
state: Wisconsin
city: Ponce
country: Puerto Rico
facility: Centro de Investigacion Clinica Psiquiatrica
city: San Juan
country: Puerto Rico
facility: Dharma Institute and Research Center
city: San Juan
country: Puerto Rico
facility: INSPIRA Clinical Research
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: