Clinical trial NCT01110902: Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
Official title: A 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: 589
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: University of Alabama at Birmingham, Department of Psychiatry
state: Alabama
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: El Centro
country: United States
facility: Valley Clinical Research
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Altamonte Springs
country: United States
facility: ICSL 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: Miami
country: United States
facility: Innova Clinical Trials
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
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: Park Ridge
country: United States
facility: CNS Clinical Trials
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Pikesville
country: United States
facility: Pharmasite Research
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Brighton
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatry Group, LLC
state: Nebraska
city: Willingboro
country: United States
facility: CRI Worldwide, LLC - Lourdes Division
state: New Jersey
city: Brooklyn
country: United States
facility: Social Psychiatric Research Institute
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Service
state: New York
city: Canton
country: United States
facility: Neurobehavioral Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: SP Research
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC - Kirkbride Division
state: Pennsylvania
city: North Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Memphis
country: United States
facility: Research Strategies
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Department of Psychiatry
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research
state: Washington
city: Bayamon
country: Puerto Rico
facility: Caribbean Research and Education Center
city: San Juan
country: Puerto Rico
facility: Dharma Institute and Research Center
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: