A Prospective, Single Center, Open-Label, Non-Comparative, Interventional, Clinical Decision Based, Investigator Initiated Study for Evaluation of Efficacy and Safety of Dosulepin Hydrochloride in Patients with SSRI Non-Respondent Major Depressive Disorder

Dr M Suresh Kumar0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients of either sex in the age group of 18-65 years.
•2.Patient willing to participate in the study and sign an informed consent form.
•3.Patients with the diagnosis of the Depressive episode (Single episode or recurrent) (by ICD-10 DCR) without psychotic symptoms.
•4.Exhibiting treatment non-response (less than 50% reduction in depressive symptoms) after four weeks of treatment with SSRIs, during which the patient has had an adequate dose for at least three weeks.
•5.A condition of general good physical health.
•6.Patients with no cognitive impairments and having Mini-Mental State Examination (MMSE) scale score of >=24.

•1.Patients with the Depressive episode (by ICD-10 DCR) with psychotic symptoms.
•2.Patients who underwent electroconvulsive therapy within 2 months.
•3.Pregnant and nursing women.
•4.Women with childbearing potential who are not practicing a reliable method of birth control.
•5.Patients with comorbid substance abuse or history of organicity.
•6.Patients with a history of the Obsessive-compulsive disorder.
•7.Patients with a history of major medical or neurological illness.
•8.Patients with recent myocardial infarction, any degree of heart block or other cardiac arrhythmias.
•9.Patients with the severe liver disease.
•10.Suspected inability or unwillingness to comply with study procedures.
•11.Known intolerance to any of the ingredients of Dosulepin.

发起方

Dr M Suresh Kumar