Combination therapy of standard antidepressant with oral ketamine as first-line therapy in Late-life Depression: An Open-label Trial

King George Medical University0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

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•Patient and Caregiver both giving valid informed consent.
•A patient diagnosed with the first episode or recurrent episodes of depressive disorder, moderate or severe (F32.1, F32.2, F33.1, F33.2 with or without F34.1 as per ICD 10).
•Hamilton Rating Scale for Depression (HAMD 17) score of at least 14 or above and on the Geriatric Depression Scale (GDS -30 ) score of at least 20 or above.
•Drug-free patient in the current episode - >No previous therapeutic exposure to any anti-depressant in the current episode.
•Free of antidepressant use in last two weeks (Patients with previous antidepressant treatment); For fluoxetine, the patient should be free from the drug over the last six weeks.

•Presence of any psychotic symptoms in the current episode or other co-morbid psychiatric disorders (excluding personality disorders).
•Current history of substance abuse, harmful use, and dependence (except for Tobacco).
•Presence of any Neurological disorder like Parkinsonâ??s disease, Cerebrovascular stroke, or dementia of any type.
•History of intracranial mass, intracranial hemorrhage, Cerebral trauma/ traumatic brain injury.
•Uncontrolled Hypertension, uncontrolled Diabetes, or any medical illness requiring immediate intervention.
•Patient on thyroxin or any other disorder involving the endocrine system.
•Current medical history of severe renal or hepatic insufficiency.
•Vitamin B12 deficiency or raised homocysteine level as evident on recent (within four weeks) serum levels.
•Any contraindications for ketamine or an antidepressant being used (e.g; hyponatremia )( For ketamine: Acute Porphyrias, severe cardiac disease, uncontrolled hypertension, history of head trauma, history of stroke) [22]
•Any previous reaction to ketamine ( as reported by the participant)

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