Trial Outcomes & Findings for Ketamine in Adolescents With Treatment-Resistant Depression (NCT NCT02078817)

NCT ID: NCT02078817

Last Updated: 2020-01-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

2 weeks

Results posted on

2020-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine 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 Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine 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 Study Withdrawal by Subject	1

Baseline Characteristics

Ketamine in Adolescents With Treatment-Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=13 Participants 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.
Age, Categorical <=18 years	11 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	16.9 years STANDARD_DEVIATION 0.95 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants
Estimated intelligence quotient	114.1 IQ STANDARD_DEVIATION 56.96 • n=99 Participants
Socioeconomic Status (SES)	56.96 units on a scale STANDARD_DEVIATION 7.45 • n=99 Participants
Body Mass Index	30.7 kg/m^2 STANDARD_DEVIATION 6 • n=99 Participants
Children's Depression Rating Scale-Revised Score	63.9 units on a scale STANDARD_DEVIATION 12 • n=99 Participants
Beck Depression Inventory-II	29 units on a scale STANDARD_DEVIATION 10 • n=99 Participants
Montgomery-Asberg Depression Rating Scale (MADRS)	30.15 units on a scale STANDARD_DEVIATION 5 • n=99 Participants
Age of depression onset	12.6 years STANDARD_DEVIATION 2.9 • n=99 Participants
Duration of current depressive episode	3.8 years STANDARD_DEVIATION 1.6 • n=99 Participants
Number of Past Treatments	5.7 Past treatments STANDARD_DEVIATION 3.1 • n=99 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Number of Responders Measured by Clinical Global Impression (CGI)	5 Participants

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Children's Depression Rating Scale-Revised	44.1 score on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Montgomery-Åsberg Depression Rating Scale (MADRS)	18.5 score on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Beck Depression Inventory-II (BDI-II)	17.8 score on a scale Standard Deviation 15.7

SECONDARY outcome

Timeframe: baseline, 2 weeks

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.

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Change in Clinician Administered Dissociative States Scale (CADSS)	-19.8 score on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: 2 hours and 40 minutes

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.

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Maximum Change in Systolic Blood Pressure	13.9 mmHg Standard Deviation 9.4

SECONDARY outcome

Timeframe: baseline, 45 minutes post infusion

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Maximum Change in Diastolic Blood Pressure	13.6 mmHg Standard Deviation 11.7

SECONDARY outcome

Timeframe: 4 hours

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Maximum Change in Heart Rate	8.9 beats per minute Standard Deviation 8.8

SECONDARY outcome

Timeframe: 4 hours

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants 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.
Maximum Decrease in Pulse Oximetry	-2.5 percent Standard Deviation 9.4

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=13 participants at risk 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.
Gastrointestinal disorders Nausea	23.1% 3/13 • Number of events 3 • 2 weeks
General disorders Headache	7.7% 1/13 • Number of events 1 • 2 weeks
General disorders Hand Pain	7.7% 1/13 • Number of events 1 • 2 weeks

Additional Information

Katherine Cullen

University of Minnesota

Phone: 612-273-9732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place