Trial Outcomes & Findings for Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression (NCT NCT04011592)

Results Overview

The Hamilton Depression Rating Scale (HAM-D) score ranges from 0-53. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms. The value reported is the score at baseline minus the score 24 hours post-injection.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

baseline, 24 hours post-injection

Results posted on

2021-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg) Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg) Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)	Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg) Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg) Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg n=1 Participants single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg) Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg) Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)	Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg) Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg) Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)	Total n=1 Participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION NA • n=5 Participants	—	37 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 24 hours post-injection

The Hamilton Depression Rating Scale (HAM-D) score ranges from 0-53. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms. The value reported is the score at baseline minus the score 24 hours post-injection.

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=1 Participants Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)	Ketamine 0.2 mg/kg n=1 Participants Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)
Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score	9 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant.	3 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant.

SECONDARY outcome

Timeframe: 24 hours post-injection

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=1 Participants Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)	Ketamine 0.2 mg/kg n=1 Participants Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)
Number of Treatment-Emergent Adverse Events moderate nausea	1 adverse events	0 adverse events
Number of Treatment-Emergent Adverse Events mild headache	1 adverse events	1 adverse events

SECONDARY outcome

Timeframe: baseline, 24 hours post-injection

The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30. Higher scores indicate worse outcome, with a score of 10 or greater indicating depression. The value reported is the score at baseline minus the score at 24 hours post-injection.

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=1 Participants Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)	Ketamine 0.2 mg/kg n=1 Participants Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)
Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale	8 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant.	2 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant.

SECONDARY outcome

Timeframe: baseline, 24 hours post-injection

The Generalized Anxiety Disorder 7-Item (GAD-7) Scale score ranges from 0 to 21, with higher scores indicating greater anxiety. The value reported is the score at baseline minus the score 24 hours post-injection.

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=1 Participants Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)	Ketamine 0.2 mg/kg n=1 Participants Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)
Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale	5 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant.	0 score on a scale Standard Deviation NA Standard Deviation is not calculable for 1 participant.

SECONDARY outcome

Timeframe: baseline, 24 hours post-injection

Population: This outcome measure was not assessed and no data were collected.

The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 24 hours post-injection

Population: This outcome measure was not assessed and no data were collected.

The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. The first part (Items 1-5) rates an individual's degree of suicidal ideation on a 0-5 scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors". The C-SSRS outcomes are categories and have binary responses (yes/no). Suicidal ideation is considered when the patient responds a "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5) on the C-SSRS. The sum of the 5 intensity item scores create a total score (range 0 to 25) to represent the intensity rating (higher scores indicate more severe suicidal ideation).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 24 hours post-injection

Population: This outcome measure was not assessed and no data were collected.

The questions 6-10 of the C-SSRS are related to suicidal behavior, and the outcome is a simple yes/no response. Suicidal behavior occurs if the patient answers a "yes" at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10) on the C-SSRS.

Outcome measures

Outcome data not reported

Adverse Events

Ketamine 0.5 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ketamine 0.2 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine 0.5 mg/kg n=1 participants at risk Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg)	Ketamine 0.2 mg/kg n=1 participants at risk Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg)
General disorders Mild headache	100.0% 1/1 • Number of events 1 • 24 hours	100.0% 1/1 • Number of events 1 • 24 hours
General disorders Moderate Nausea	100.0% 1/1 • Number of events 1 • 24 hours	0.00% 0/1 • 24 hours

Additional Information

Sudhakar Selvaraj, MD, PhD, Assistant Professor

The University of Texas Health Science Center at Houston

Phone: 713-486-2837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place