Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00467402
First received: April 27, 2007
Last updated: May 2, 2012
Last verified: May 2012
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Purpose
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: agomelatine Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Time to relapse, where relapse is defined by the occurrence of any one of the following: [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
- Hamilton Depression Rating Scale total score ≥16 at two consecutive visits; [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
- hospitalization due to depression; [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
- suicide attempt or suicide; [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
- discontinuation due to lack of efficacy according to Investigator judgment. [ Time Frame: Primary efficacy variable is measured from randomization to relapse ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients who demonstrate clinical improvement at the end of the double-blind continuation phase, where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale. [ Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase ] [ Designated as safety issue: No ]
- Proportion of patients experiencing relapse during the double-blind continuation phase. [ Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase ] [ Designated as safety issue: No ]
- Proportion of patients who achieve remission at the end of the double-blind continuation phase, where remission is defined by a total score of ≤7 on the HAM-D. [ Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase ] [ Designated as safety issue: No ]
- Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores. [ Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase ] [ Designated as safety issue: No ]
| Enrollment: | 644 |
| Study Start Date: | April 2007 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: agomelatine |
| Experimental: 2 | Drug: agomelatine |
| Placebo Comparator: 3 | Drug: placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female adults, 18 through 70 years of age, inclusive
- Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
- A history of at least two previous episodes of Major Depression plus the current episode
- Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline
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
- Use of any psychoactive medication after the screening visit
- Patients who have been previously treated with 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: NCT00467402
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Sponsors and Collaborators
Novartis
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00467402 History of Changes |
| Other Study ID Numbers: | CAGO178A2304 |
| Study First Received: | April 27, 2007 |
| Last Updated: | May 2, 2012 |
| 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 23, 2013