Ketamine in Adolescents With Treatment-Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02078817

Recruitment Status : Completed

First Posted : March 5, 2014

Results First Posted : January 27, 2020

Last Update Posted : January 27, 2020

Sponsor:

Information provided by (Responsible Party):

University of Minnesota

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Major Depressive Disorder
Intervention	Drug: Ketamine
Enrollment	14

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Ketamine
Arm/Group Description	Intravenous ketamine 0.5 mg/kg over...
Arm/Group Description	Intravenous ketamine 0.5 mg/kg over 40 minutes will be given 6 times over 2 weeks. Ketamine: IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period.
Period Title: Overall Study
Started	14
Completed	13
Not Completed	1
Reason Not Completed
Withdrawal by Subject	1

Baseline Characteristics

Arm/Group Title		Ketamine
Arm/Group Description		Intravenous ketamine 0.5 mg/kg over...
Arm/Group Description		Intravenous ketamine 0.5 mg/kg over 40 minutes will be given 6 times over 2 weeks. Ketamine: IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period.
Overall Number of Baseline Participants		13
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants
	<=18 years	11 84.6%
	Between 18 and 65 years	2 15.4%
	>=65 years	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	13 participants
		16.9 (0.95)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants
	Female	5 38.5%
	Male	8 61.5%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	13 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	13 participants
United States		13
Estimated intelligence quotient Mean (Standard Deviation) Unit of measure: IQ
	Number Analyzed	13 participants
		114.1 (56.96)
Socioeconomic Status (SES) ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	13 participants
		56.96 (7.45)
		[1] Measure Description: SES was measured using the Hollingshead Four Factor Index of Socioeconomic Status, an instrument measuring the marital status, retired/employed status, educational attainment, and occupational prestige of the parents of child participants. Parent education is rated on a 7-point scale. Parent occupation is coded on a 9-point scale. Education and occupation scores are then weighted to obtain a single score for each parent (range 8 to 66). For households with 2 parents, scores are averaged. Higher scores indicate greater socioeconomic status (more financial and social resources).
Body Mass Index Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	13 participants
		30.7 (6)
Children's Depression Rating Scale-Revised Score ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	13 participants
		63.9 (12)
		[1] Measure Description: The CDRS-R measure is given in interview form to child and parent separately. A consensus is then created with best-estimate for 17 items (each with a range of 1-5 or 1-7) using both sources of information. The total score is the sum of 17 item scores, ranging from 17-113 with higher scores indicating greater depression symptoms.
Beck Depression Inventory-II ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	13 participants
		29 (10)
		[1] Measure Description: BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.
Montgomery-Asberg Depression Rating Scale (MADRS) ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	13 participants
		30.15 (5)
		[1] Measure Description: MADRS is a 10-item clinician-administered inventory measuring depression symptoms. Items are scored on a scare from 0 (none) to 6 (constant). Total scores are a sum of the 10 item scores, ranging from 0 to 60, with higher scores indicating greater symptom severity.
Age of depression onset Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	13 participants
		12.6 (2.9)
Duration of current depressive episode Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	13 participants
		3.8 (1.6)
Number of Past Treatments Mean (Standard Deviation) Unit of measure: Past treatments
	Number Analyzed	13 participants
		5.7 (3.1)

Outcome Measures

1.Primary Outcome


Title	Number of Responders Measured by Clinical Global Impression (CGI)
Description	Responders will be defined as those with CGI ratings (given by the stu...
Description	Responders will be defined as those with CGI ratings (given by the study clinician) of 1 or 2 (much or very much improved). Patients that are given a scores of 3-7 (minimally improved to very much worse) will be considered non-responders.
Time Frame	2 weeks

Outcome Measure Data