CTRI/2013/11/004127已完成3 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients must be able to provide written informed consent to participate before beginning any trial related activities.
- •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
- •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.
- •Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days.
- •Patients previously unresponsive to SSRIs
- •Serious psychiatric co-morbidity (as per investigatorâ??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
研究者
相似试验
招募中
不适用
Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract CancerKCT0007476SMT Bio128
进行中（未招募）
1 期
A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and AdolescentsMedDRA version: 19.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disordersMigraineEUCTR2015-004880-35-Outside-EU/EEAGlaxoSmithKline Research & Development Ltd178
进行中（未招募）
1 期
A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/ARheumatoid ArthritisEUCTR2004-002132-26-GBF. Hoffmann-La Roche Limited160
进行中（未招募）
1 期
A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of rhuMAb 2H7 (Ro 496-4913, PRO70769) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/ARheumatoid ArthritisEUCTR2004-002132-26-ESF Hoffmann-La Roche Limited160
进行中（未招募）
1 期
A multi-center, randomized, double-blind, placebocontrolled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload - TELESTOmyelodysplastic syndromes(low/int-1 risk)MedDRA version: 12.1Level: LLTClassification code 10019613Term: HemosiderosisEUCTR2009-012418-38-ITOVARTIS FARMA630