EICHORCondition: Major Depressive Disorder · Sponsor: Novartis Pharmaceuticals
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Birmingham Psychiatry | Birmingham, Alabama, United States | — |
| Southwestern Research Institute | Beverly Hills, California, United States | — |
| Pharmacology Research Institute | Encino, California, United States | — |
| Mood & Anxiety Research | Fresno, California, United States | — |
| Excell Research, Inc | Oceanside, California, United States | — |
| Cnri-La, Llc | Pico Rivera, California, United States | — |
| CNRI San Diego | San Diego, California, United States | — |
| University of California San Diego Medical Center | San Diego, California, United States | — |
| University of Colorado Denver | Aurora, Colorado, United States | — |
| Western Affiliated Research Institute | Denver, Colorado, United States | — |
| Clinical Research Institute of South Florida | Hialeah, Florida, United States | — |
| Florida Clinical Research Center LLC | Maitland, Florida, United States | — |
+ 36 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT01110889