Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

Stopped early · Phase 3

Conditions studied: Major Depressive Disorder

In brief

The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase. Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study. Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.

Key facts

Study ID

NCT01156415

Run by

Novartis Pharmaceuticals

People needed

837

Starts

2010-06-01

Expected to finish

2011-10-01

Last updated by the study team

2020-12-24

Who can join

Age: 18 and older, up to 71. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Key Inclusion Criteria Cohort I:
• Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
• Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study).
• Female patients should continue to use effective contraception as defined in double-blind study protocol.
• Inclusion Criteria:
• Key Inclusion criteria Cohort II:
• Male and female adults, 18 through 70 years of age, inclusive.
• Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
• Current episode ≥4 weeks.
• CGI-Severity score ≥4 at Screening and Baseline.

You may not qualify if…

• Key Exclusion Criteria Cohort I:
• Concomitant use of fluvoxamine.
• Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator.
• Exclusion Criteria:
• Key Exclusion criteria Cohort II:
• 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.
• Prior exposure to agomelatine.
• Female patients of childbearing potential who are not using effective contraception.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Advanced Research Associates — Glendale, Arizona, United States
• Southwest Health Ltd dba The Mollen Clinic — Scottsdale, Arizona, United States
• Clinical Study Centers, LLC — Little Rock, Arkansas, United States
• Southwestern Research Institute — Beverly Hills, California, United States
• Comprehensive Neuroscience — Cerritos, California, United States
• ATP Clinical Research, Inc — Costa Mesa, California, United States
• Collaborative Neuroscience Network — Garden Grove, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Pacific Clinical Research Medical Group — Orange, California, United States
• CNRI-San Diego, LLC — San Diego, California, United States
• University of California, San Diego Medical Center — San Diego, California, United States
• Neuropsychiatric Research Center of Orange County — Santa Ana, California, United States
• Viking Clinical Research Center — Temecula, California, United States
• Collaborative Neuroscience — Torrance, California, United States
• University of Colorado — Aurora, Colorado, United States
• Western Affiliated Research Institute — Denver, Colorado, United States
• Middlesex Hospital — Middletown, Connecticut, United States
• Clinical Studies — Altamonte Springs, Florida, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Arocha Research Center — Coral Gables, Florida, United States
• CNS Clinical Research — Coral Springs, Florida, United States
• Sjs Clinical Research — Destin, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• CNS Healthcare — Jacksonville, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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