Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT01110902
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 589
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGO178C 0.5 mg /day Agomelatine (AGO178C) - AGO178C 1 mg / day Agomelatine (AGO178C) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale Baseline and 8 weeks
- Secondary Outcome Measures
Name Time Method 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 Proportion of patients who achieve remission 8 weeks 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 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 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
Related Research Topics
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Trial Locations
- Locations (45)
University of Alabama at Birmingham, Department of Psychiatry
🇺🇸Birmingham, Alabama, United States
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
Valley Clinical Research
🇺🇸El Centro, California, United States
Collaborative Neuroscience Network
🇺🇸Garden Grove, California, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Viking Clinical Research
🇺🇸Temecula, California, United States
ICSL Clinical Studies
🇺🇸Altamonte Springs, Florida, United States
Scroll for more (35 remaining)University of Alabama at Birmingham, Department of Psychiatry🇺🇸Birmingham, Alabama, United States