A clinical trial to study the effect of a combination therapy (oral ketamine and escitalopram) and escitalopram alone in elderly patient with depression, when given early in the course of treatment.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051777

Enrollment

Registered

2023-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 2: F331- Major depressive disorder, recurrent, moderate Health Condition 3: F321- Major depressive disorder, singleepisode, moderate Health Condition 4: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: Oral Ketamine plus Tab Escitalopram: Active group: Oral Ketamine Dose: 2.5mg/kg body weight. Administration: Mix 200 ml of fruit Juice or 200 ml of water for a diabetic patient. The pat

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
DECREASE IN SEVERITY OF DEPRESSIVE SYMPTOMS ( DECREASE IN HAM D scores) Side effects reportedTimepoint: DAY 0 DAY 1-7 DAY 7 DAY 14 DAY 42	—

Secondary

Measure	Time frame
to assess the association between depressive symptoms with blood biomarkersTimepoint: Day 0 day 14	—

Countries

India

Contacts

Public ContactSujita Kumar Kar

King George Medical University

drsujita@gmail.com9410965553

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026