A Randomized, Multicenter, Open Label, Placebo Controlled Study to Evaluate the Efficacy, Tolerability, and Safety of Vilazodone in Indian Adult Patients with Major Depressive Disorder (MDD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 9
- 主要终点
- •Change from baseline to week 8 in the Hamilton Rating Scale for Depression (HAM-D-17) total score
研究概览
简要总结
This study is an open label, randomized, multiple-dose, parallel study to evaluate the safety and efficacy of Vilazodone product (Hetero) and Reference product (Escitalopram) in patients diagnosed with major depressive disorder. The primary objective is to assess the efficacy and safety of vilazodone (40mg/day) administered to adult patients with a major depressive disorder, as measured by mean change from baseline in the Hamilton Rating Scale for Depression (HAM-D-17), at week 8 or end of treatment visitsxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The secondary objectives areto assess the efficacy of vilazodone (40mg/day) by using secondary measures of depression, anxiety, and overall clinical impression using the Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (HAM-A), and Clinical Global Impression Severity (CGI-S), and Sheehan disability scale and to assess the safety profile of vilazodone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Patients must be able to provide written informed consent to participate before beginning any trial related activities.
- •â€¢Male or female outpatients between 18-65 years of age with MDD •HAM-D-17 score ≥20 •Patients must have general ocular health •Females of child bearing potential with negative pregnancy test and using double barrier contraceptive measures .
- •A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR with a current major depressive episode of less than two years duration with a minimum duration of at least four weeks.
排除标准
- •â€¢ HAM-D-17 score decreased by ≥25% between screening and baseline •Actively suicidal or likely to require hospitalization during the trial •Electroconvulsive Therapy within six months of screening •Patients requiring other psychotropic medications and central nervous system active drugs •Patients with clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic or pulmonary disease •Patients taking migraine medications with a serotonergic mechanism of action or NSAIDS or drugs that effect coagulation •Patients taking CYP3A4 inhibitors/inducers, and monoamine oxidase (MAO) inhibitors (or within 14 days of stopping MAO inhibitors) •Patients with a known hypersensitivity to SSRIs or 5-HT1a agonists •Patients with symptomatic hyponatremia •Patients previously treated with vilazodone •Patients with a history of seizure disorders •Female patients must not be pregnant, not lactating, and not planning to become pregnant during the time of study participation.
- •All female patients who are not at least 1 year post-menopausal or irreversibly surgically sterilized must be using adequate and reliable contraception throughout the trial •Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
- •â€¢Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days.
- •â€¢Patients previously unresponsive to SSRIs •Serious psychiatric co-morbidity (as per investigator’s discretion); although generalized anxiety disorder (GAD), social phobia, simple phobia were permitted •A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes) •History of inadequate response to 2 consecutive antidepressants •DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to screening visit or substance dependence within 6 months prior to the screening visit •Serious medical co-morbidity.
结局指标
主要结局
•Change from baseline to week 8 in the Hamilton Rating Scale for Depression (HAM-D-17) total score
时间窗: Change from baseline to week 8
次要结局
- MADRS (Montgomery-Asberg Depression Rating Scale) total score, HAM-A total score, CGI-S total score, Sheehan disability scale(Safety End Points)