CTRI/2011/08/001946RecruitingPhase 3
"A Multicentric, Open-label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Efficacy and Safety of Agomelatine oral tablets in patients with Major Depressive Disorder
Precise Chemipharma Pvt Ltd4 sites in 1 country200 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- The primary efficacy parameter is the evaluation of MDD symptom score in the second week and at the end of the trial.
Study Overview
Brief Summary
This study is A Multicentric, Open-label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Efficacy and Safety of Agomelatine oral tablets in patients with Major Depressive Disorder that will be conducted in four centres in India
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All subjects with duly filled and signed in ICFs [Informed Consent Forms].
- •Adult males or females, age 18-65 years (inclusive).
- •Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria.
- •HAM-D17 total score less than or 22 at Screening and Baseline.
- •CGI-Severity score less than 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
- •Patients with seasonal patterns, psychotic features or post-partum onset.
- •Patients with other types of depression or psychiatric conditions (including bipolar I and II or dysthymic disorders) and those who displayed marked suicidal intent or known suicidal tendencies.
- •Patients undergoing electroconvulsive treatment, insight-oriented or structured psychotherapy during the 3 months prior to assessment.
- •Patients who are otherwise eligible but who had not derived clinical benefit from two adequate antidepressant trials for the current episode, or from a previous trial of Agomelatine, will also be excluded.
- •History of 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.
Outcomes
Primary Outcomes
The primary efficacy parameter is the evaluation of MDD symptom score in the second week and at the end of the trial.
Time Frame: second week
Secondary Outcomes
- 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 ](8 weeks)
- To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of more than or 7 on the HAM-D17 [Time Frame: 8 week](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 [Time Frame: 8 weeks](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 [Time Frame: 8 weeks] 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](8 weeks)
Investigators
Study Sites (4)
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