Regulation of brain biogenic amines in mild to moderate degree of depression by a plant based formulation

Department of Science Technology0 个研究点目标入组 1,000 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.Have had depressive symptoms for a level â?? one month prior to screen visit.
•2.Feeling of minimum three or more clinical symptoms like â?? evidence of low mood, sadness, emptiness, hopelessness , helplessness, worthlessness, feeling of guilt, irritable, anxious, worried, restlessness.
•3.Depressed subjects must score on (18) on the HAM-D at screening visit and MRI screening session.
•4.Hindi Speaking/local language
•Diagnosed depression patients willing to participate in clinical trial program. Those depression patients showed clinical symptoms like lack of interest, poor concentration, pessimistic thinking, early fatigability, poor sleep, poor appetite, weight loss, psychomotor retardation. The screening of depression patients were carried out on Hamilton Psychiatric rating Scale (DSM-IV).

•1.Any history of seizures
•2.Diabetes requiring insulin treatment
•3.A serious heart disorder/heart attack within the last 3 months
•4.Subjects who meet DSM-IV criteria for alcohol /drug abuse or dependence within the last six months
•5.Other current DSM-IV Axis I or Axis II diagnoses
•6.A personal or family history of bipolar disorder
•7.Current use of medication that affects CNS function
•8.Participation in last 30 days in study involving an investigational drug
•9.A subject with metallic implants, such as prostheses, shrapnel or aneurysm clip-S, or persons with electronic implants, such as cardiac pacemakers
•10.A subject who is claustrophobic
•11.Females who are pregnant, trying to become pregnant/not using birth control
•12.A subject at serious risk for suicide
•13.Had a diagnosis of cancer in the past 3 years and/or has active neoplastic disease
•14.Non-response to 2 adequate trials of antidepressant treatment
•15.Non-response to 2 adequate trials of an empirically supported psychotherapy

发起方

Department of Science Technology