Trial Outcomes & Findings for The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression. (NCT NCT03156504)

Last Updated: 2022-03-15

Results Overview

Total number of subjects with ≤ 9 MADRS score 24 hours post Ketamine infusion #3. The Montgomery Åsberg Depression Scale (MÅDRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

24 hours post infusion #3

Results posted on

2022-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers). Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
Overall Study STARTED	75
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers). Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=75 Participants Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers). Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
Age, Continuous	44.27 years STANDARD_DEVIATION 12.87 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post infusion #3

Outcome measures

Outcome measures
Measure	Ketamine n=74 Participants Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers). Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
Clinical Remission of Depression	39 Participants

PRIMARY outcome

Timeframe: 24 hours post infusion #3

Total number of subjects to have a reduction of suicidality, as defined by a 50% reduction on the Beck Scale for Suicidal Ideation (BSS) 24 hours post Ketamine infusion #3. The Beck Scale for Suicidal Ideation consists of 19 items which can be used to evaluate a patient's suicidal intentions. Each of the 19 items is rated on a 0-3 point scale (range 0-38, with higher scores indicating greater suicidal ideations or risk), and includes specific items that assess wish to live, wish to die, desire to make an active suicide attempt, passive suicidal desire, duration of suicidal ideations, frequency of suicidal ideations, and subjective level of control over suicidal actions.

Outcome measures

Outcome measures
Measure	Ketamine n=74 Participants Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers). Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
Suicidal Ideation	42 Participants

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=75 participants at risk Subjects will receive three IV Ketamine Hydrochloride infusions (0.5 mg/kg, infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers). Ketamine Hydrochloride: Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
General disorders Lightheadedness with low blood pressure	1.3% 1/75 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 5-7 weeks on all participants
Product Issues Pump Malfunction	1.3% 1/75 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 5-7 weeks on all participants
Psychiatric disorders PTSD	1.3% 1/75 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 5-7 weeks on all participants

Additional Information

Dr. Jennifer Vande Voort

Mayo Clinic

Phone: 507-255-6782

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place