Trial Outcomes & Findings for Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder (NCT NCT01667926)

NCT ID: NCT01667926

Last Updated: 2017-04-20

Results Overview

The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: up to 4 months
• Results posted on: 2017-04-20

Participant Flow

Outpatients were recruited primarily through referrals.

Participant milestones

Measure	Ketamine Subject will receive 6 infusions of ketamine over three weeks. Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.	Placebo Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo	Screen Fail/No Baseline Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria. Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions.
Overall Study STARTED	13	13	11
Overall Study COMPLETED	8	9	0
Overall Study NOT COMPLETED	5	4	11

Reasons for withdrawal

Measure	Ketamine Subject will receive 6 infusions of ketamine over three weeks. Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.	Placebo Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo	Screen Fail/No Baseline Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria. Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions.
Overall Study Withdrawal by Subject	1	2	2
Overall Study Physician Decision	0	0	1
Overall Study Time committment	0	0	2
Overall Study Inclusion/Exclusion Criteria	0	0	5
Overall Study Lost to Follow-up	1	2	1
Overall Study Side effects	3	0	0

Baseline Characteristics

Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

Baseline characteristics by cohort

Measure	Ketamine n=13 Participants Subject will receive 6 infusions of ketamine over three weeks. Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.	Placebo n=13 Participants Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.5 years STANDARD_DEVIATION 13.6 • n=5 Participants	45.3 years STANDARD_DEVIATION 11.7 • n=7 Participants	45.4 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 4 months

The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.

Outcome measures

Measure	Ketamine n=8 Participants Subject will receive 6 infusions of ketamine over three weeks. Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.	Placebo n=9 Participants Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo
Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)	1.6 units on a scale Standard Deviation 1.4	1.6 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: up to 5 months

Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.

Outcome measures

Measure	Ketamine n=8 Participants Subject will receive 6 infusions of ketamine over three weeks. Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.	Placebo n=9 Participants Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo
HDRS-28 Total	20.2 units on a scale Standard Deviation 11.1	20.0 units on a scale Standard Deviation 10.7

Adverse Events

Ketamine

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ketamine n=13 participants at risk Subject will receive 6 infusions of ketamine over three weeks. Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.	Placebo n=13 participants at risk Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo
Infections and infestations Unrelated hospitalization	7.7% 1/13 • Number of events 1 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.	0.00% 0/13 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.
Psychiatric disorders Worsening Depression	15.4% 2/13 • Number of events 2 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.	0.00% 0/13 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.

Other adverse events

Measure	Ketamine n=13 participants at risk Subject will receive 6 infusions of ketamine over three weeks. Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.	Placebo n=13 participants at risk Subjects will receive 6 infusions of normal saline over 3 weeks. Placebo
General disorders Ketamine side effects	15.4% 2/13 • Number of events 3 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.	0.00% 0/13 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.
Psychiatric disorders Psychiatric Hospitalization	0.00% 0/13 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.	7.7% 1/13 • Number of events 1 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.
General disorders Diarrhea	7.7% 1/13 • Number of events 1 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.	0.00% 0/13 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.
General disorders Blood Pressure elevated	7.7% 1/13 • Number of events 1 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.	0.00% 0/13 • up to 3 months Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.

Additional Information

Dr. Cristina Cusin

Massachusetts General Hospital

Phone: 6177263855

Email: ccusin@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place