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

This study has been terminated.
Sponsor:
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
  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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156415

  Show 98 Study Locations
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, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
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 September 22, 2014