Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01156415
First received: June 30, 2010
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: AGO178 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD) |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale [ Time Frame: Week 6, 8, 12, 28, 36 and 52 ] [ Designated as safety issue: No ]
- Proportion of patients who demonstrate clinical improvement at Week 6,8,12, 28,36 and 52, where improvement is defined by a score of 1 or 2 on the CGI-I scale [ Time Frame: Week 6, 8, 12, 28, 36 and 52 ] [ Designated as safety issue: No ]
- Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
| Enrollment: | 837 |
| Study Start Date: | June 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Agomelatine (AGO178) 0.5 mg | Drug: AGO178 |
| Experimental: Agomelatine (AGO178) 1 mg | Drug: AGO178 |
Eligibility| Ages Eligible for Study: | 18 Years to 71 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156415
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| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Advanced Research Associates | |
| Glendale, Arizona, United States, 85308 | |
| Southwest Health Ltd dba The Mollen Clinic | |
| Scottsdale, Arizona, United States, 85254 | |
| United States, Arkansas | |
| Clinical Study Centers, LLC | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Southwestern Research Institute | |
| Beverly Hills, California, United States, 90210 | |
| Comprehensive Neuroscience | |
| Cerritos, California, United States, 90703 | |
| ATP Clinical Research, Inc | |
| Costa Mesa, California, United States, 92626 | |
| Collaborative Neuroscience Network | |
| Garden Grove, California, United States, 92845 | |
| Pharmacology Research Institute | |
| Newport Beach, California, United States, 92660 | |
| Pacific Clinical Research Medical Group | |
| Orange, California, United States, 92868 | |
| University of California, San Diego Medical Center | |
| San Diego, California, United States, 92103 | |
| CNRI-San Diego, LLC | |
| San Diego, California, United States, 92102 | |
| Neuropsychiatric Research Center of Orange County | |
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| Middlesex Hospital | |
| Middletown, Connecticut, United States, 06457 | |
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| San Juan, Puerto Rico, 00907 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01156415 History of Changes |
| Other Study ID Numbers: | CAGO178C2399 |
| Study First Received: | June 30, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
agomelatine Major Depressive Disorder MDD depression |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms S 20098 |
Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013