Open-label Long Term (52 Weeks) Safety and Tolerability o... | NCT01156415

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jun 30, 2010

First Submission Date that Met QC Criteria

Jul 1, 2010

First Posted Date

Jul 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 14, 2013

Certification/Extension First Submitted that Passed QC Review

Feb 14, 2013

Certification/Extension First Posted Date

Feb 20, 2013Estimated

Last Update Submitted Date

Dec 16, 2020

Last Update Posted Date

Dec 24, 2020Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

837Actual

Label	Type	Description	Intervention Names
Agomelatine (AGO178) 0.5 mg	Experimental		Drug: AGO178
Agomelatine (AGO178) 1 mg	Experimental		Drug: AGO178

Name	Type	Description	Arm Group Labels	Other Names
AGO178	Drug		Agomelatine (AGO178) 1 mg
AGO178

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale		52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale		Week 6, 8, 12, 28, 36 and 52
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

71 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Advanced Research Associates

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior