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Ketamine in Adolescents With Treatment-Resistant Depression

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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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine
Hide 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
Arm/Group Title Ketamine
Hide 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
Hide 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
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)
1.Primary Outcome
Title Number of Responders Measured by Clinical Global Impression (CGI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
5
  38.5%
2.Secondary Outcome
Title Children's Depression Rating Scale-Revised
Hide 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
44.1  (16.3)
3.Secondary Outcome
Title Montgomery-Åsberg Depression Rating Scale (MADRS)
Hide 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
18.5  (11.2)
4.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
17.8  (15.7)
5.Secondary Outcome
Title Change in Clinician Administered Dissociative States Scale (CADSS)
Hide Description CADSS is a 27-item instrument measuring symptoms of dissociative stress, with 19 items completed by the patient and 8 items completed by the clinician. Items are rated on a scale of 0 (not at all) to 4 (extreme). Total scores are a sum of the 27 item scores and range from 0 to 108, with higher scores indicating greater symptom severity.
Time Frame baseline, 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
-19.8  (14.8)
6.Secondary Outcome
Title Maximum Change in Systolic Blood Pressure
Hide Description Vital signs were measured every 15 minutes, starting from the beginning of the infusion and ending 2 hours after the infusion ended (2 hours, 40 minutes total). Maximum increase of blood pressure compared to baseline was calculated.
Time Frame 2 hours and 40 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmHg
13.9  (9.4)
7.Secondary Outcome
Title Maximum Change in Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame baseline, 45 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmHg
13.6  (11.7)
8.Secondary Outcome
Title Maximum Change in Heart Rate
Hide Description [Not Specified]
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: beats per minute
8.9  (8.8)
9.Secondary Outcome
Title Maximum Decrease in Pulse Oximetry
Hide Description [Not Specified]
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
Hide 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 Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: percent
-2.5  (9.4)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine
Hide 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.

All-Cause Mortality
Ketamine
Affected / at Risk (%)
Total   0/13 (0.00%)    
Hide Serious Adverse Events
Ketamine
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine
Affected / at Risk (%) # Events
Total   5/13 (38.46%)    
Gastrointestinal disorders   
Nausea   3/13 (23.08%)  3
General disorders   
Headache   1/13 (7.69%)  1
Hand Pain   1/13 (7.69%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Katherine Cullen
Organization: University of Minnesota
Phone: 612-273-9732
EMail: rega0026@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02078817    
Other Study ID Numbers: 22225
First Submitted: February 27, 2014
First Posted: March 5, 2014
Results First Submitted: November 15, 2019
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020