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

Macsur Pharmaa I Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. 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.
•4. Patients who are previously on SSRIs anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks.
•Ã¯â??Â· Patients who are previously on SSRIs

•1. 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.
•3. 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 Ã?Â²-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.
•8. 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.

发起方

Macsur Pharmaa I Pvt Ltd