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
- 试验地点
- 3
- 主要终点
- Mean change in scores of 17-item Hamilton Rating Scale for Depression - HAM-D-17
研究概览
简要总结
Vilazodone is an attractive treatment option for the relief of Major Depressive Disorder. Major Depressive Disorder is a condition characterized by one or more Major Depressive Episodes without a history of Manic, Mixed, or Hypomanic Episodes. These Major Depressive Episodes are not due to a medical condition, medication, abused substance, or Psychosis. If Manic, Mixed, or Hypomanic Episodes develop, the diagnosis is changed to Bipolar Disorder.
Vilazodone represents another option for the treatment of MDD. Vilazodone appears to have a favourable weight-gain proï¬le based on short-term studies. Existing treatments often are not satisfactory. Antidepressants frequently subject their users to bizarre sexual side effects such as loss of libido, “genital anesthesia†and “pleasureless orgasm.†CDI reported a phase III trial result showing the drug was effective for depression and was the same as a placebo for sexual side effects. Importantly, though, is the fact that some people develop adverse effects at the doses required to achieve adequate pain control. Though many drugs have been tried for the management of MDD, no drug has been proved significantly effective and a search for better drug continues. So, the aim of this study is to evaluate Safety, Efficacy and Tolerability of Vilazodone Hydrochloride 40 mg Tablet in the management of MDD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •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 >
- •5.Female patients of child bearing potential should have negative Urine Pregnancy Test (UPT) at the time of screening.
- •6.Patients or patient’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 Investigator’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.
- •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.
结局指标
主要结局
Mean change in scores of 17-item Hamilton Rating Scale for Depression - HAM-D-17
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
Mean change in scores of Arizona Sexual Experience Scale - ASEX
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
Mean changes in vital parameters
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
Mean change in scores of Montgomery-Asberg Depression Rating Scale - MADRS
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
SAFETY
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
Proportion of patients reporting incidences of AE and/or SAE during study and their assessment
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
Mean changes in visual acuity and slit-lamp examination observations
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
EFFICACY
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
Mean changes in body weight and lab parameters
时间窗: EFFICACY | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | SAFETY | Each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of protocol therapy [visit 6] | Baseline to each post randomization visit [Days 7, 14, 28, 57] | Baseline to end of the protocol therapy [Day 57] | Baseline to the end of protocol therapy [Day 57]
次要结局
- Mean change in the Clinical Global Impression – Severity Scale (CGI-S) score(Baseline to end of the protocol therapy [Day 57])
- Mean score of Clinical Global Impression - Improvement scale (CGI-I) at the end of the therapy(End of protocol therapy [Day 57])
- Proportion of ‘Responders’ defined as patients achieving response defined as ≥50% decrease in the total score of HAM-D-17 at the end of the protocol therapy as compared to baseline(Baseline to the end of protocol therapy [Day 57])