A study to compare drugs Vortioxetine and Escitalopram, used for treatment of Depression

Not Applicable

Completed

• Conditions: Major depressive disorder, recurrent, unspecified,

• Registration Number: CTRI/2019/11/022030
• Lead Sponsor: Dr Anshul Upadhyay

Brief Summary

Depression may bea feeling of state of dejection, sadness, or unhappiness, which may be brief induration or a clinical syndrome characterized by persistent sadness, profounddiscouragement, or despair which persists two weeks or more and is associated witha change from previous functioning.

It is also characterized by diminishedinterest in normal activities, mental slowing and poor concentration, insomniaor increased sleep, significant weight loss or gain due to altered eating andactivity patterns, psychomotor agitation or retardation, feelings of guilt andworthlessness, decreased energy and libido, and suicidal ideation. (1)(2)

Depression is the leading cause ofdisability worldwide, and is a major contributor to the overall global burden ofdisease. According to American Psychiatric Association, Depression affects anestimated 1 in 15 adults (6.7%) in any given year. And 1 in 6 people (16.6%)will experience depression at some time in their life. (1)

There are many first-line medicationsavailable for depression but none meet the desirable outcome. Among patientsreceiving the currently available first-line treatment medications about 30–40%achieve a full remission and another one third respond to therapy but haveresidual symptoms. (3) Less than half of patients with depressionadhere to their antidepressant regimen for the recommended duration, in partbecause of side-effects such as sleep disturbances, sexual dysfunction, andweight gain. (3) Thus, thereis a strong need for improved therapies that have better tolerability andeffectiveness.

Vortioxetine is a newantidepressant for the treatment of depression which was approved on September2013 by FDA (4) and May 2018 by DCGI. (5) . The mechanismof action of vortioxetine is thought to be related to a combination of two pharmacologicalmodes of action: direct modulation of receptor activity and inhibition of the5-HT (serotonin) transporter. (6)In vitro, vortioxetine acts as a 5-HT1Areceptor agonist, 5-HT1B receptor partial agonist, 5-HT3, 5-HT7, and 5-HT1Dreceptor antagonist and inhibitor of the 5-HT transporter (SERT) (7).This multimodalpharmacological activity is thought to be responsible for the antidepressanteffects and improvement of cognitive function of vortioxetine. Its single dosetherapy is also an advantage. As it is a relatively new drug, no clinicaltrials are available for this drug in Indian population. So this study willhelp to assess the efficacy and safety of this drug in Indian population.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-12
• Study Completion: 2021-09-30
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Patients with primary diagnosed depression with MADRS (Montgomery–Åsberg Depression Rating Scale) score >22 and no other concurrent psychiatric disorders at baseline.
• 2.Patients of 18 – 60 years of age 3.Subjects of either gender 4.Subjects willing to give written informed consent.

Exclusion Criteria

• 1.Patients with history of substance abuse.
• 2.Patients with two failed previous antidepressant treatments (of at least 6 weeks in duration) 3.Patient with any other long-term treatment like anti-hypertensive, anti-diabetic, anti-tubercular 4.Patients with neurological disorders (dementia, stroke, seizures), obesity with functional impairment, serious or not stabilized organic disorder (neoplastic, cardiovascular, pulmonary, uncontrolled diabetes).
• 5.Patients who pose a significant risk of suicide, had a score of 5 on item 10 (suicidal thoughts) of the MADRS or had made a suicide attempt in the previous 6 months.
• 6.Patients who have received electroconvulsive therapy in the preceding 6 months.
• 7.Patients who have MADRS (Montgomery–Åsberg Depression Rating Scale) score <22 at baseline.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in MADRS (Montgomery–Åsberg Depression Rating Scale) score between Vortioxetine group and Escitalopram group at 8 weeks	0 and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Difference in CGI (Clinical Global Impression) score between Vortioxetine group and Escitalopram group at 8 weeks	0 and 8 weeks
Difference in HDRS (Hamilton Depression Rating Scale) score between Vortioxetine group and Escitalopram group at 8 weeks	0 and 8 weeks
Difference in DSST (Digit Symbol Substitution Test) score between Vortioxetine group and Escitalopram group at 8 weeks	0 and 8 week
Difference in PDQ-5 (Perceived deficits questionnaire-5) score between Vortioxetine group and Escitalopram group at 8 weeks	0 and 8 weeks
Change in the values of baseline laboratory investigations (Complete blood count, Liver function test, Renal function test) seen after 8th week in Vortioxetine and Escitalopram group.
Change in mean patient weight at 8 weeks in Vortioxetine and Escitalopram group	0 and 8 weeks

Trial Locations

Locations (1)

Government Medical College and Hospital, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Government Medical College and Hospital, Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Anshul Upadhyay

Principal investigator

9039307820

anshul.upadhyayy@gmail.com