Major Depressive Disorder (MDD)
Conditions
Keywords
agomelatine, major depressive disorder, MDD, depression
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.
Interventions
DRUGagomelatine
DRUGplacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed