Major Depressive Disorder Clinical Trial
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)
NCT number | NCT01110889 |
Other study ID # | CAGO178C2301 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2010 |
Verified date | February 2013 |
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 | 582 |
Est. completion date | |
Est. primary completion date | July 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 | Inspira Clinical Research | San Juan | |
United States | Neurological Associates Of Albany, P.C. | Albany | New York |
United States | Albuquerque Neuroscience | Albuquerque | New Mexico |
United States | Lehigh Center for Clinical Research | Allentown | Pennsylvania |
United States | Atlanta Center for Medical Research | Atlanta | Georgia |
United States | University of Colorado Denver | Aurora | Colorado |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Southwestern Research Institute | Beverly Hills | California |
United States | Birmingham Psychiatry | Birmingham | Alabama |
United States | Montefiore Medical Center | Bronx | New York |
United States | Neurobehavioral Research Inc. | Cedarhurst | New York |
United States | Rush University Medical Center | Chicago | Illinois |
United States | The Ohio State University - Harding Hospital | Columbus | Ohio |
United States | FutureSearch Trials of Dallas | Dallas | Texas |
United States | KRK Medical Research | Dallas | Texas |
United States | Midwest Clinical Research Center | Dayton | Ohio |
United States | Western Affiliated Research Institute | Denver | Colorado |
United States | InSite Clinical Research | DeSoto | Texas |
United States | Mountain West Clinical Trials | Eagle | Idaho |
United States | Pharmacology Research Institute | Encino | California |
United States | Odyssey Research Services | Fargo | North Dakota |
United States | Psychiatric Consultants | Franklin | Tennessee |
United States | Mood & Anxiety Research | Fresno | California |
United States | Comprehensive Psychiatric Associates | Gladstone | Missouri |
United States | Clinical Research Institute of South Florida | Hialeah | Florida |
United States | Hawaii Clinical Research Center | Honolulu | Hawaii |
United States | Texas Center for Drug Development | Houston | Texas |
United States | Florida Clinical Research Center LLC | Maitland | Florida |
United States | Northwest Behavioral Research Center | Marietta | Georgia |
United States | Sunstone Medical Research, LLC | Medford | Oregon |
United States | Clinical Trials Management | Metairie | Louisiana |
United States | Excell Research, Inc | Oceanside | California |
United States | Cutting Edge Research | Oklahoma City | Oklahoma |
United States | IPS Research Company | Oklahoma City | Oklahoma |
United States | CNS Healthcare | Orlando | Florida |
United States | Psychiatric Associates | Overland Park | Kansas |
United States | Broward Research Group | Pembroke Pines | Florida |
United States | Cnri-La, Llc | Pico Rivera | California |
United States | Quantum Lab. N. Broward Memory Disorder Center | Pompano Beach | Florida |
United States | CTT Clinical Trials Technology | Prairie Village | Kansas |
United States | Psychopharmacology Research Association of Princeton | Princeton | New Jersey |
United States | Alliance Research Group, LLC | Richmond | Virginia |
United States | Finger Lakes Clinical Research | Rochester | New York |
United States | CNRI San Diego | San Diego | California |
United States | University of California San Diego Medical Center | San Diego | California |
United States | Bio Behavioral Health | Toms River | New Jersey |
United States | Mount Auburn Medical Associates | Watertown | Massachusetts |
United States | Coastal Research Associates | Weymouth | Massachusetts |
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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