Clinical trial NCT01110889: Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
Official title: An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Agomelatine
Major Depressive Disorder
MDD
depression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.


Eligibility criteria: Inclusion Criteria:

* Patients with 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:

* 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.
* Concomitant psychotropic medication, including herbal preparations and melatonin.
* Psychotherapy of any type.
* 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: Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8
timeFrame: 8 weeks
measure: Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint
timeFrame: 8 weeks
measure: Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale
timeFrame: 8 weeks
measure: Proportion of patients who achieve remission
timeFrame: 8 weeks
measure: Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry
state: Alabama
city: Beverly Hills
country: United States
facility: Southwestern Research Institute
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Fresno
country: United States
facility: Mood & Anxiety Research
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Pico Rivera
country: United States
facility: Cnri-La, Llc
state: California
city: San Diego
country: United States
facility: CNRI San Diego
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Hialeah
country: United States
facility: Clinical Research Institute of South Florida
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center LLC
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Group
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Lab. N. Broward Memory Disorder Center
state: Florida
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: Eagle
country: United States
facility: Mountain West Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Prairie Village
country: United States
facility: CTT Clinical Trials Technology
state: Kansas
city: Metairie
country: United States
facility: Clinical Trials Management
state: Louisiana
city: Watertown
country: United States
facility: Mount Auburn Medical Associates
state: Massachusetts
city: Weymouth
country: United States
facility: Coastal Research Associates
state: Massachusetts
city: Gladstone
country: United States
facility: Comprehensive Psychiatric Associates
state: Missouri
city: Princeton
country: United States
facility: Psychopharmacology Research Association of Princeton
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience
state: New Mexico
city: Albany
country: United States
facility: Neurological Associates Of Albany, P.C.
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research Inc.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Fargo
country: United States
facility: Odyssey Research Services
state: North Dakota
city: Columbus
country: United States
facility: The Ohio State University - Harding Hospital
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
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: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Franklin
country: United States
facility: Psychiatric Consultants
state: Tennessee
city: Dallas
country: United States
facility: KRK Medical Research
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: Texas Center for Drug Development
state: Texas
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: San Juan
country: Puerto Rico
facility: Inspira Clinical Research
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: