A study comparing vilazodone with escitalopram in terms of efficacy , safety and onset of action in patients with depression.

Phase 4

Recruiting

• Conditions: Major depressive disorder, singleepisode, unspecified,

• Registration Number: CTRI/2019/01/017302
• Lead Sponsor: Dr Ankushe rohini

Brief Summary

A prospective, randomized, active–controlled, parallel–group comparativeopen label study will be conducted on total 92 patients of major depressivedisorder at psychiatry OPD, meeting inclusion criteria, after permission ofInstitutional ethics committee. Prior permission from head of department ofpharmacology, psychiatry, pathology, biochemistry, will be taken. Registrationto clinical trial registry (CTRI) will be done.  GCP guidelines willbe strictly followed.

Diagnosis of patient as a patient of major depressive disorder will bedone by psychiatrist. A written informed consent from the patient or legalguardian of patient will be taken after explaining nature and purpose of studyin their own language. Patient information sheet containing all the necessarydetails of study will be provided to patient. Eligible patients will berandomized using block permutation method with allocation ratio of 1:1 toreceive either escitalopram or vilazodone.

Patient’s details will betaken on a proforma, including patients age ,sex, occupation , religion,marital status ,type of family , total family members , total income, per capitaincome, socio -economic class (by B.G. Prasad classification) ,history of  any medical illness , duration and treatmentreceived for the same will be recorded. Family h/o any psychiatric disorder will also be taken. Also patient’sweight, BP, will be recorded. Weight of patient will be taken on a same typedigital weighing machine throughout the study. BP of patient will be recordedwith same type of sphygmomanometer till the end of study. CBC, serumcreatinine, serum urea, liver function tests will be done, at baseline (day 1),4thweek, and at 12 weeks at the same institution with same method.

Before starting treatment, baseline(day 1)Hamilton depression ratingscale  (HAM- D),Hamilton anxiety  rating scale (HAM –A) ,Montgomery –AsbergDepression rating scale (MADRS), clinical global impression- severity (CGI-S)score will be taken, also baseline(day 1) blood investigations such as CBS, LFT ,RFT will be done afterwhich  treatment with either  vilazodone (10mg ) or Escitalopram(5mg)orally as prescribed by psychiatrist will be started. Patient will be advisedto take vilazodone with food. Dose of the drug will be doubled every week maximumupto 40 mg for vilazodone and for escitalopram dose will be increased by 5mgevery week maximum upto 20mg if inadequate response is obtained .

Subsequent follow -up will be taken at 1st , 2nd ,4 th and12th week and changes in the HAM –D , HAM–A, MADRS , clinical globalimpression improvement (CGI –I) and clinical global impression severity (CGI-S)Score will be recorded. Follow up blood investigation will be done at 4thand 12th week. The primary efficacy outcomes will be taken as changefrom the baseline in the values of HAM-D17 total score (change frombaseline to last post baseline assessment).secondary outcome measurers will beHAM –A, MADRS and CGI-I, CGI–S score, total 50% reduction in scores will beconsidered as response to therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• 1)Patients of either sex with age between 18 to 65 years.
• 2)Newly diagnosed MDD patients meeting DSM- 5 criteria for depression.
• 3)Patient who give written informed consent.

Exclusion Criteria

• 1)Pregnant or nursing women.
• 2)Patients with high risk of suicidal tendency or previous suicide attempt within 6 months.
• 3)Patients with bipolar disorder, drug abuse or dependency, post traumatic stress disorder, obsessive – compulsive disorder.
• 4)Patients with previous depression resistant to antidepressants and those who had taken treatment with electroconvulsive therapy in previous 3 months or formal psychotherapy within 1 month.
• 5)Patients on other antidepressants.
• 6)Patients with neurological disorders (dementia, seizures, stroke), obesity with functional impairment, serious or unstable organic disorder (neoplasia, cardiovascular, pulmonary,uncontrolled type 1 or 2 diabetes).
• 7)Any other medical disorder which is confounding our inclusion diagnosis.
• 8)Patients with drug intake for psychosis or anxiety.
• 9)Any history of allergy to the drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2)Udvalg for Kliniske Undersolgelser(UKU)scale.	Time point : 12 weeks .
serum creatinine & serum urea.]	Time point : 12 weeks .
3)Blood investigations[CBC, SGOT,SGPT ,serum bilirubin(direct and indirect)	Time point : 12 weeks .
Outcome name : 1)Hamilton Depression Rating Scale.(used for sample size calculation. )	Time point : 12 weeks .

Secondary Outcome Measures

Name	Time	Method
Outcome name: 1)Hamilton Anxiety Rating Scale(HAM-A).	2)Montgomery-Asberg Depression Rating Scale(MADRS).

Trial Locations

Locations (1)

Government Medical College ,Latur.; 🇮🇳 Latur, MAHARASHTRA, India

Government Medical College ,Latur.

🇮🇳Latur, MAHARASHTRA, India

Dr Ankushe Rohini

Principal investigator

8310831326

ankusherohini@gmail.com