Major Depressive Disorder Clinical Trial
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)
NCT number | NCT01110902 |
Other study ID # | CAGO178C2302 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2010 |
Est. completion date | June 2011 |
Verified date | September 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 589 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Caribbean Research and Education Center | Bayamon | |
Puerto Rico | Dharma Institute and Research Center | San Juan | |
United States | ICSL Clinical Studies | Altamonte Springs | Florida |
United States | Emory University | Atlanta | Georgia |
United States | FutureSearch Trials | Austin | Texas |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | University of Alabama at Birmingham, Department of Psychiatry | Birmingham | Alabama |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Florida Clinical Research Center, LLC | Bradenton | Florida |
United States | Boston Clinical Trials | Brighton | Massachusetts |
United States | Social Psychiatric Research Institute | Brooklyn | New York |
United States | Neurobehavioral Clinical Research | Canton | Ohio |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Arocha Research Center | Coral Gables | Florida |
United States | ATP Clinical Research | Costa Mesa | California |
United States | Valley Clinical Research | El Centro | California |
United States | Willamette Valley Clinical Studies | Eugene | Oregon |
United States | Deaconess Clinic | Evansville | Indiana |
United States | Collaborative Neuroscience Network | Garden Grove | California |
United States | Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois |
United States | Claghorn-Lesem Research Clinic, Inc. | Houston | Texas |
United States | Joliet Center for Clinical Research | Joliet | Illinois |
United States | Premier Psychiatry Group, LLC | Lincoln | Nebraska |
United States | CNS Healthcare | Memphis | Tennessee |
United States | Research Strategies | Memphis | Tennessee |
United States | Innova Clinical Trials | Miami | Florida |
United States | Eastside Comprehensive Medical Service | New York | New York |
United States | Medical University of South Carolina | North Charleston | South Carolina |
United States | SP Research | Oklahoma City | Oklahoma |
United States | University of California, Irvine Medical Center | Orange | California |
United States | CNS Clinical Trials | Park Ridge | Illinois |
United States | CRI Worldwide, LLC - Kirkbride Division | Philadelphia | Pennsylvania |
United States | Pharmasite Research | Pikesville | Maryland |
United States | Summit Research Network | Portland | Oregon |
United States | Anderson Clinical Research | Redlands | California |
United States | Mercy Health Research | Saint Louis | Missouri |
United States | University of Utah, Department of Psychiatry | Salt Lake City | Utah |
United States | Affiliated Research Institute | San Diego | California |
United States | Summit Research | Seattle | Washington |
United States | California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California |
United States | Miami Research Associates | South Miami | Florida |
United States | Viking Clinical Research | Temecula | California |
United States | Neurology & Neuroscience Center of Ohio | Toledo | Ohio |
United States | Heartland Research Associates, LLC | Wichita | Kansas |
United States | CRI Worldwide, LLC - Lourdes Division | Willingboro | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale | Baseline and 8 weeks | ||
Secondary | Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8 | 8 weeks | ||
Secondary | 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 | 8 weeks | ||
Secondary | 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 | 8 weeks | ||
Secondary | Proportion of patients who achieve remission | 8 weeks | ||
Secondary | Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale. | 8 weeks |
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