A Clinical trial to study the efficacy and safety of Ketamine on patient with Severe depression.

Efficacy and safety of ADD-ON intravenous Ketamine in DSM-V diagnosed severe depressive disorder;a double blind controlled trial. - DEPKET

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037627

Enrollment

Registered

2021-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: F333- Major depressive disorder, recurrent, severe with psychotic symptoms Health Condition 3: F321- Major depressive disorder, singleepisode, moderate Health Condition 4: F323- Major depressive disorder, singleepisode, severe with psychotic features Health Condition 5: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: ketamine : 1.Dose-0.5mg/kg diluted in 50ml normal saline over 40mins 2.Frequency-In every 72hours in two weeks 3.Route of Administration- Interavenous 4.Duration of therapy- 2 weeks Co

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with severe depression according to the DSM-5 guidelines and ham-d score suggesting Depression. Patients who give their consent

Exclusion criteria

Exclusion criteria: 1.Patients with present diagnosis or antecedents of clinically relevant cardiovascular disorder such as stroke, heart attack,etc 2.Patients with present or past diagnosis of glaucoma, intracranial hypertension 3.Patients with current diagnosis of schizophrenia and related disorder 4.Significant ECG abnormalities 5.History of neurological disease or prior head trauma with evidence of cognitive impairment 6.Known hypersensitivity to ketamine 7.Patients who donot give their informed consent

Design outcomes

Primary

Measure	Time frame
Outcome of treatment will be measured in terms of reduction of the HAM-D score by more than 50% Timepoint: by at the end of two weeks	—

Secondary

Measure	Time frame
Reduction in the score of suicidal risk Improvement in the global functioning Persistance of response to as shown by the reduction of HAM-D score for 4 weeks following the discontinuation of ketamine Timepoint: Reduction of HAM-D score for 4 weeks following the discontinuation of ketamine	—

Countries

India

Contacts

Public ContactDr Anand Prakash

KIMS and PBMH,Bhubaneshwar

linksudipta@gmail.com9439728347

Outcome results

None listed

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