Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00411099

Purpose

This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: agomelatine Drug: placebo	Phase III

MedlinePlus related topics: Depression

Drug Information available for: S 20098

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8-Week, Randomized, Double-Blind, Fixed Dosage, Placebo-Controlled, Parallel-Group, Multi-Center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-Week, Open-Label Extension (CAGO178A2301E)

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	490
Study Start Date:	December 2006
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: agomelatine
2: Experimental	Drug: agomelatine
3: Placebo Comparator	Drug: placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
HAM-D17 total score > or = 22 at Screening and Baseline
CGI-Severity score > or = 4 at Screening and Baseline
Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase

Exclusion Criteria:

History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
Any current Axis I disorder other than major depressive disorder which is the focus of treatment
Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
Concomitant psychotropic medication, including herbal preparations and melatonin
Psychotherapy of any type
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: NCT00411099

Show 42 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

(Agomelatine clinical trials information website) This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAGO178A2301
Study First Received:	December 11, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00411099
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

agomelatine, major depressive disorder, MDD, depression

Study placed in the following topic categories:

S 20098
Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009