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

TERMINATEDPHASE3

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

A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)

NCT01156415•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 71 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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.
•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.

Locations (98)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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

Key Dates

Start Date

June 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

December 24, 2020

Enrollment

837

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

AGO178

DRUG

AGO178

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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