Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Agomelatine (AGO178C)

• Registration Number: NCT01110889
• 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

Study Timeline

• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Study Start: 2010-05
• Primary Completion: 2011-07
• Status Verified: 2013-02
• Disposition First Submitted: 2013-02-18
• Disposition First Submitted QC: 2013-02-18
• Disposition First Posted: 2013-02-22
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AGO178C 1 mg / day	Agomelatine (AGO178C)	-
AGO178C 0.5 mg /day	Agomelatine (AGO178C)	-

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
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 improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale	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
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
Proportion of patients who achieve remission	8 weeks

Trial Locations

Locations (48)

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

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