An Open Prospective Trial of IV Ketamine in Suicidal Adolescents

Phase 2

• Conditions: Major Depressive Disorder
• Interventions: Drug: Ketamine

• Registration Number: NCT02048423
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

1. Investigate the safety and effectiveness of a single dose of IV Ketamine for adolescents with suicidal ideation and depression. It is hypothesize that Ketamine will be well tolerated and significantly reduce depressive symptoms and suicidal ideation.

2. Explore whether decision making as measured by the Iowa Gambling Task changes before and after Ketamine infusion. It is hypothesize that IV Ketamine infusion will significantly improve the decision making ability a measured by the Iowa Gambling Task in adolescents that are suicidal.

Detailed Description

This is an open prospective study of a single, low dose (0.5 mg/kg) intravenous (IV) Ketamine in 10 adolescent subjects admitted to Nationwide Childrens Hospital following a serious suicide attempt and who meet criteria for major depression or bipolar disorder I, current episode depressed. Subjects will be recruited via the psychiatry consult service, evaluated on the floor and if eligible and consent is obtained, transferred to the PACU for IV Ketamine infusion. Following infusion and when PACU discharge criteria are met, subjects will be transferred back to their floor for medical and psychiatric monitoring until they can be transferred to an inpatient psychiatric unit for additional care. Subjects will be transferred to an inpatient psychiatric unit for continued psychiatric care as part of their routine psychiatric care via the consult team. The research team will follow-up by telephone one week and four weeks after Ketamine injection to collect additional information about the patient's overall course and response.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-02
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-27
• Last Update Submitted: 2014-01-27
• Study First Posted: 2014-01-29
• Last Update Posted: 2014-01-29
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	Drug

Primary Outcome Measures

Name	Time	Method
Change in Quick Inventory of Depression Clinician (QIDS-C) total scores from baseline to endpoint and Clinical Global Improvement Score.	2 days

Secondary Outcome Measures

Name	Time	Method
Clinical Global Assessment Scale	2 days

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States