Trial Outcomes & Findings for Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder (NCT NCT02660528)

NCT ID: NCT02660528

Last Updated: 2020-10-20

Results Overview

Absolute change on Hamilton Depression Rating Scale (HDRS) score

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline to 8 Weeks

Results posted on

2020-10-20

Participant Flow

No participants were assigned to treatment arms because none of the participants were eligible to continue the study after screening.

Participant milestones

Participant milestones
Measure	Tocilizumab Tocilizumab 162 mg sc q2weeks x 4 doses Tocilizumab: Subcutaneous tocilizumab
Overall Study STARTED	0
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Demographics n=3 Participants Demographics of screened subjects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	55.67 years STANDARD_DEVIATION 2.52 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 Weeks

Population: No data was collected for the study outcome measures because none of the participants were eligible to continue the study after screening.

Absolute change on Hamilton Depression Rating Scale (HDRS) score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 Weeks

Population: No data was collected for the study outcome measures because none of the participants were eligible to continue the study after screening.

Proportion of Subjects with an HDRS score \< 7

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 Weeks

Population: No data was collected for the study outcome measures because none of the participants were eligible to continue the study after screening.

Proportion of Subjects with an HDRS score decreased \>50% from baseline

Outcome measures

Outcome data not reported

Adverse Events

Tocilizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jessica Harder

Brigham and Women's Hospital

Phone: 617-525-7919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place