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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01156415
Recruitment Status : Terminated
First Posted : July 2, 2010
Last Update Posted : March 14, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: AGO178 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 837 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : June 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Agomelatine (AGO178) 0.5 mg Drug: AGO178
Experimental: Agomelatine (AGO178) 1 mg Drug: AGO178

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01156415

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01156415     History of Changes
Other Study ID Numbers: CAGO178C2399
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Major Depressive Disorder

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs