Health Condition 1: null- Newly diagnosed patients with Major Depressive Disorders
Conditions
Interventions
Intervention1: Vilazodone Hydrochloride: Dosage form: Tablet
Dose: 10 mg OD for first 7 days titrated to 20 mg OD for next 7 days followed by titration of dose to 40 mg OD for 42 days
Frequency: Onc
Sponsors
MSN Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFFICACY Mean change in scores of 17-item Hamilton Rating Scale for Depression - HAM-D-17 Mean change in scores of Montgomery-Asberg Depression Rating Scale - MADRS SAFETY Proportion of patients reporting incidences of AE and/or SAE during study and their assessment Mean change in scores of Arizona Sexual Experience Scale - ASEX Mean changes in vital parameters Mean changes in visual acuity and slit-lamp examination observations Mean changes in body weight and lab parametersTimepoint: 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] | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the Clinical Global Impression â?? Severity Scale (CGI-S) scoreTimepoint: Baseline to end of the protocol therapy [Day 57];Mean score of Clinical Global Impression - Improvement scale (CGI-I) at the end of the therapyTimepoint: End of protocol therapy [Day 57];Proportion of â??Respondersâ?? defined as patients achieving response defined as â?¥50% decrease in the total score of HAM-D-17 at the end of the protocol therapy as compared to baselineTimepoint: Baseline to the end of protocol therapy [Day 57] | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed