Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in Subjects with Major Depressive Disorder with Associated Anxiety

Not Applicable

Completed

Conditions: Major depressive disorder, recurrent, unspecified,

Registration Number: CTRI/2020/08/026974

Lead Sponsor: Macsur Pharmaa I Pvt Ltd

Brief Summary: **Title :** An Open Label, Multicentre, Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice.

**Study Rationale :** The purpose of this study is to collect clinical data, mainly focusing on safety, in the local target population (200 eligible subjects) with major depressive disorder (MDD) associated with anxiety, to meet a regulatory requirement of Central Drugs Standard Control Organisation (CDSCO) in India for market authorization.

**Design and Investigational Plan :** This is an open-label, post-marketing study to evaluate safety and efficacy on administration of fixed dose combination (FDC) of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in patients with major depressive disorder with associated anxiety. The total study duration will be approximately 8 weeks. The trial will consist of a wash-out period of 7-10 days, a 1-day Screening/Baseline visit on Day 1 (Visit 1), followed by telephonic visit at Week 4 (Visit 2) and End of study Visit (Week 8). All subjects will be prescribed Escitalopram 5 mg/10 mg and Etizolam 0.5 mg once a day, orally at Baseline (Visit 1) at their investigatorâ€™s discretion. During the treatment period, subject data will be collected at telephonic visit and at EOS at the clinic visits. Subjects are followed up by their investigator according to clinical need. Subjects will be instructed to report any adverse events (AE)/serious adverse event (SAE) within the course of the study. Data in a routine clinical monitoring of subjects are collected in the paper case report form (CRF).

**Data Analysis Methods :** No statistical hypothesis testing will be done and data will be presented using descriptive statistics. Continuous data will be presented by using summary statistics such as mean, median, standard deviation, minimum and maximum. Categorical data will be presented with counts and percentages. For each individual AEs will be coded by using world health organization adverse reaction terminology (WHOART) according to the local regulation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

Willing and able to sign informed consent form.
Written informed consent must be obtained before any assessment is performed 2.
Male and female subjects of aged 18 years to 75 years 3.
Patients suffering from MDD with associated anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks.
Patients who are previously on SSRIs anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks.
ï‚· Patients who are previously on SSRIs.

Exclusion Criteria

Hypersensitivity to Escitalopram 5 mg/10 mg and Etizolam 0.5 mg or any excipients 2.
Should not be suffering from any other psychiatric illness or any other chronic disease which would interfere with trial assessments.
Known contraindication for the use of Escitalopram or Etizolam 4.
Patients with serotonin syndrome 5.
Should not be SSRI resistant (not responding to 4-6 weeks of SSRI previously) 6.
Any other treatments such as fluoxetine (SSRI), other antidepressants,hienodiazepine, benzodiazepines, barbiturates, or Î²-blockers potentially resulting in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication 7.
Any medical (eg, cardiac, liver, renal, endocrinologic, neoplastic, pulmonary) or neurologic (eg, bipolar disorder, schizophrenia) disease and other clinical conditions.
A history of drug or alcohol abuse within the past 6 months 9.
Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study 10.
Female who is pregnant, nursing, or of child-bearing potential.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the safety and efficacy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in patients with major depressive disorder associated with anxiety in regular clinical practice	Day 1 : Screening/ Baseline Visit. \| Week 4 : Telephonic Visit. \| Week 8 : End of study. Data collection.

Secondary Outcome Measures

Name	Time	Method
To demonstrate the efficacy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in patients with major depressive disorder associated with anxiety in regular clinical practice	The primary efficacy is evaluated by using Montgomery-Ã…sberg Depression Rating Scale (MADRS) at Week 8 and ï‚· The secondary efficacy is evaluated by using Hamilton Depression Rating Scale17 (HAMD-17) at Week 8.

Trial Locations

Locations (3): Ishwar Institute of Health Science Padegaon
🇮🇳
Aurangabad, MAHARASHTRA, India
Medstar Speciality Hospital
🇮🇳
Bangalore, KARNATAKA, India
Udyaan Health care,
🇮🇳
Lucknow, UTTAR PRADESH, India
Ishwar Institute of Health Science Padegaon
🇮🇳Aurangabad, MAHARASHTRA, India
Dr Amol Deshmukh
Principal investigator
7057418854
ishwarhealthcare@gmail.com