| CTRI Number |
CTRI/2014/01/004273 [Registered on: 02/01/2014] Trial Registered Prospectively |
| Last Modified On: |
02/02/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial study of two drugs Vilazodone Hydrochloride 40 mg OD and Fluoxetine Hydrochloride 20 mg OD in patients with major depressive disorders. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX-VILA/CT-III/5006/10-2011(Ver No.03, dated: 13/05/2013) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malayakant Singh |
| Designation |
Principal Investigator |
| Affiliation |
MV Hospital and Research Centre |
| Address |
Department of Psychiatric, MV Hospital and Reserach Centre
314/30 Mirza Mandi Chowk
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
05222258215 |
| Fax |
05224016051 |
| Email |
malayakant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
President & CEO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
32 A, Nexus Center For Clinical Excellence, Sector-1, Shiravane Road, Service Industry, Mumbai-Pune Highway, Nerul (East), Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
02227714204 |
| Fax |
|
| Email |
dramit.bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Bhatt |
| Designation |
President & CEO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
32 A, Nexus Center For Clinical Excellence, Sector-1, Shiravane Road, Service Industry, Mumbai-Pune Highway, Nerul (East), Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
02227714204 |
| Fax |
|
| Email |
dramit.bhatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| MSN Laboratories Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
MSN Laboratories Pvt Ltd |
| Address |
MSN House, Plot No:- C-24,
Industrial Estate, Sanath Nagar,
Hyderabad – 500018, Andhra Pradesh, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Anand |
Kanoria Hospital and Research Centre |
Department of Psychiatry, Airport-Gandhinagar highway, village:Bhat
Gandhinagar
GUJARAT |
079-23969274
-
drrajendrannand@yahoo.com |
| Dr Malayakant Singh |
MV Hospital and Reserach Centre |
Department of Psychiatry, 314/30, Mirza Mandi, Chowk,
Lucknow
UTTAR PRADESH |
05222258215
05224016051
malayakant@gmail.com |
| Dr Neelanjana Paul |
Peerless Hospital and BK Roy Research Centre |
Department of Psychiatry, 360, Panchasayar
Kolkata
WEST BENGAL |
033-24622394
-
neelanjana.paul@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ashirwad Hospital & Research Centre |
Submittted/Under Review |
| B.J. Medical College & Civil Hospital, Ahmedabad |
Submittted/Under Review |
| Ethics Committee, Medilink Ethics Committee |
Approved |
| Ethics Committee, Osmania medical College |
Submittted/Under Review |
| Health Point Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committe for MV Hospital & Research Centre |
Approved |
| Institutional Ethics Committee, Dept. of Pharmacology, JIPMER, Puducherry |
Submittted/Under Review |
| Institutional Ethics committee, Institute of Haematology and Transfusion Medicine |
Submittted/Under Review |
| Institutional Ethics Committee, Peerless Hospital and B.K. Roy Research centre |
Approved |
| The Chairperson, Institutional Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Newly diagnosed patients with Major Depressive Disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoxetine Hydrochloride |
Dosage form: Tablets
Dose: 20 mg OD for 56 days
Frequency: Once daily
Duration: 56 days (8 weeks) |
| Intervention |
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: Once Daily
Duration: 56 days (8 weeks)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 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.
|
|
| ExclusionCriteria |
| Details |
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.
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 parameters |
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 Outcome
|
| Outcome |
TimePoints |
| 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] |
| 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] |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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. |