CTRI/2014/01/004273已完成3 期
An Active-controlled, Randomized, Open-label, Parallel Group, Comparative, Multicenter, Phase III Clinical Trial to compare and evaluate the efficacy and safety of Tablet Vilazodone Hydrochloride 40 mg OD with Tablet Fluoxetine Hydrochloride 20 mg OD in patients newly diagnosed with Major Depressive Disorder.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
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
- •1.Male or female patients between 18 and 65 years.
- •2.Newly diagnosed patient who meets DSM-IV criteria for primary diagnosis of Major Depressive Disorder (MDD) as established by clinical interview using M.I.N.I. (Mini International Neuropsychiatric Interview) diagnostic interview.
- •3.Patient has a HAM-D-17 score of >=18 at screening.
- •4.Patient has a HAM-D-17 item 1 (depressed mood) score >2.
- •5.Female patients of child bearing potential should have negative Urine Pregnancy Test (UPT) at the time of screening.
- •6.Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Document.
- •7.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements.
排除标准
- •1.Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes)
- •2.Patients who meet DSM-IV criteria for substance abuse or dependence within 1 year of the screening visit
- •3.Patients who, in the Investigatorâ??s judgment, pose a serious suicidal or homicidal risk or have made a suicide attempt within 6 months prior to screening visit
- •4.Patients who are already on anti-psychotic therapy or psychotropic drugs including the investigational drugs.
- •5.Patients with history of migraine and currently on serotonergic drugs.
- •6.Patients who are currently or who will require treatment with strong CYP3A4 inhibitors (e.g., ketoconazole) or strong CYP3A4 inducers (e.g., rifampin), diltiazem, and macrolide antibiotics during the study.
- •7.Patients with a known hypersensitivity to SSRIs or 5-HT1A agonists.
- •8.Any significant systemic disease, endocrine or metabolic abnormalities.
- •9.Patients with a history of seizure disorders.
- •10.Prior history of malignancy if patient has <5 yrs. survival or completed treatment <1yr prior to enrollment and is currently without evidence of recurrence.
- •11.Patients with evidence of other central nervous system disorders including psychosis, delirium, dementia and amnesic disorders.
- •12.Patients with renal impairment (S. Creatinine > 1.5 times the normal reference values)
- •13.Patients with hepatic impairment. [SGOT, SGPT, S. Bilirubin (Total) >1.5 times the normal reference values]
- •14.Patients currently on MAOI or has received MAOI within past 14 days prior to screening visit.
- •15.Patients currently on or who may require drugs that interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
- •16.Patients who are not euthyroid.
- •17.Patients with any serious medical or neurological disorder or condition that make it unlikely that the patient could complete one year of treatment or would otherwise preclude the administration of study medication.
- •18.Female patient has a positive pregnancy test at screening, is pregnant or lactating, or is planning to become pregnant during the study period.
- •19.Presence of abnormal ECG parameters or significant cardiac disease, including uncompensated congestive heart failure, myocardial infarction within the past 6 months or known history of congenital long QT syndrome.
- •20.Patients having clinically significant abnormal laboratory findings.
- •21.Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
- •22.History of Neuroleptic Malignant Syndrome (NMS).
- •23.History of Diabetes Mellitus.
- •24.Presence of hyponatremia or Volume depleted patients.
- •25.Patients receiving diuretics.
- •26.Patients with uncontrolled hypertension.
- •27.Alcohol or substance dependence within the past 12 months or abuse within the past 3 months.
- •28.Known hypersensitivity to any drug that will be administered during the study.
- •29.Inability to comply with the protocol requirements.
- •30.Participation in any other clinical trial within 3 months of registering in this trial.
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