An Open Prospective Trial of IV Ketamine in Suicidal Adolescents

NCT02048423 | Unknown Phase 2 DMC

• 1 other identifier: IRB12-00445
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Major Depressive Disorder

Keywords

suicidal

Outcome Measures

Primary Outcomes (1)

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

  2 days

Secondary Outcomes (1)

• Clinical Global Assessment Scale

  2 days

Study Arms (1)

Ketamine

EXPERIMENTAL

Drug

Drug: Ketamine

Interventions

Ketamine DRUG

IV Ketamine, 0.5 mg/kg X 15 mins. in PACU

Also known as: Ketaset, Ketalean, Rogarsetic

Ketamine

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects age 12 years 0 months to 17 years, 11 months old
• Voluntary admission for a suicide attempt requiring medical intervention in the previous 24-48 hours (Kiddie Schedule for Affective Disorders Suicide Behavior Score \> 3).
• Meets criteria for major depression, single- or recurrent episode, non-psychotic or Bipolar I, current episode depressed, with a baseline Inventory for depression score of \> 16.
• The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent.
• English is spoken as the primary language in the home.

You may not qualify if:

• Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol.
• Admitted to Nationwide Children's Hospital involuntarily.
• Unable to assent because of severe mental retardation or incapacitating psychosis.
• General medical conditions: children with major medical conditions that would interfere with involvement in the study or the study medication will not be enrolled.
• History of physical, sexual, or emotional abuse, which results in a clinically significant impact on clinical presentation, potentially driving some of the symptoms of major depressive disorder.
• Receipt of an investigational drug within 30 days prior to study entry.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Robert A Kowatch, MD, PhD

  OSU Medical Center/Nationwide Childrens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert A Kowatch, MD, PhD

CONTACT

614-355-2872; robert.kowatch@nationwidechildrens.org

Melinda Helton, Pharm

CONTACT

614-722-2607

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: January 29, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

US (1)