Ketamine effectiveness in acute suicidality

Not yet recruiting

Conditions: Poisoning by, adverse effect of and underdosing of benzodiazepines, (2) ICD-10 Condition: T36||Poisoning by, adverse effect of and underdosing of systemic antibiotics,

Registration Number: CTRI/2025/02/080302

Lead Sponsor: ESIC Medical College and Hospital, Hyderabad

Brief Summary: An intervental study with research titile"Ketamine infusion therapy for rapid and sustained response in Acute Suicidality: A double blind, randomised placebo controlled trial ", planned with the purpose to evaluate the impact of Ketamine augmented Pharmacotherapy in achieving acute and sustained response of acute suicidal behaviour.

Objectives:

Primary Objectives : To assess the impact of Ketamine augmented pharmacotherapy in decreasing Impulsivity as in acute and sustained manner .

Secondary Objectives :

i) To study the prevalence of impulsive suicides among the suicidal attempts

ii) To study Age, gender and education patterns in suicide attempts

Study universe: Department of Psychiatry, ESIC Medical college and Hospital.

Study period: 18 months

eligibility criteria:

- Inclusion Criteria: 1) Age: 18-60 years who attempted suicide and come to ESIC hospital emergency department.

- 2) Patients who has MADRS Score : < 20

- 3) Patients who has SSI score : < 15

- 4) Patients who has BIS-11 score > 65

- 5) Subjects who are co-operative and willing to give written informed consent for participation in the study.

- Exclusion Criteria: 1) Patients with other active psychiatric disorders diagnosed according to ICD-10.

- 2)Patients who has MADRS Score : > 20

- 3) Patients who has SSI score : > 15

- 4) Patients who has BIS-11 score < 65

- 5) History of any cardiovascular disease.

- 6) Any significant neurological disorder or insult.

- 7) Patients with acute physical illness.

- 8) Known or suspected pregnancy or lactation.

- 9) Patients with intra-cranial implants, pacemakers, cochlear implants, implantation of medication pumps.

Procedure:

a. Participants meeting the inclusion and exclusion criteria will be randomized into one of two groups: ketamine infusion or placebo infusion.

b. The ketamine infusion group will receive a bolus dose of 0.5mg/kg ketamine over 40 minutes.

c. The placebo group will receive a saline infusion over the same duration and volume as the ketamine infusion.

d. Assessments of suicidal ideation, Impulsivity and depression severity will be conducted at baseline, 24 hours, and 2 weeks, 12 weeks, 24 weeks after the infusion using the [Barratt Impulsiveness Scale](https://qxmd.com/calculate/calculator_854/barratt-impulsiveness-scale-bis-11)(BIS-11), MADRS-S scale and the Beck Scale for Suicide Ideation (BSS).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 112

Inclusion Criteria

1. Age: 18-60 years who attempted suicide and come to ESIC hospital emergency department.
1. Patients who has MADRS Score : < 20 3) Patients who has SSI score : < 15 4) Patients who has BIS-11 score > 65 5) Subjects who are co-operative and willing to give written informed consent for participation in the study.

Exclusion Criteria

1. Patients with other active psychiatric disorders diagnosed according to ICD-10.
2)Patients who has MADRS Score : > 20 3) Patients who has SSI score : > 15 4) Patients who has BIS-11 score < 65 5) History of any cardiovascular disease.
1. Any significant neurological disorder or insult.
1. Patients with acute physical illness.
1. Known or suspected pregnancy or lactation.
1. Patients with intra-cranial implants, pacemakers, cochlear implants, implantation of medication pumps.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objectives : To assess the impact of Ketamine augmented Pharmacotherapy in decreasing Impulsivity.	baseline, 24 hours, and 1 week,2 weeks, 12 weeks, 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary Objectives :	i) To study the prevalence of impulsive suicides among the suicidal attempts

Trial Locations

Locations (1): ESIC Medical College and Hospital, Hyderabad
🇮🇳
Hyderabad, TELANGANA, India
ESIC Medical College and Hospital, Hyderabad
🇮🇳Hyderabad, TELANGANA, India
Dr Vinil Marwel Gundu
Principal investigator
9398027898
gvinilmarwel1@gmail.com