NCT00411099CompletedPhase 3
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 508
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Intervention: agomelatine (Drug)
2
Experimental
Intervention: agomelatine (Drug)
3
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17(8 weeks)
- To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8(8 weeks)
- 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(8 weeks)
- 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(8 weeks)
- 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(8 weeks)
Investigators
Study Sites (1)
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