Trial Outcomes & Findings for Ceftriaxone in the Management of Bipolar Depression (NCT NCT00566111)

NCT ID: NCT00566111

Last Updated: 2020-03-31

Results Overview

Number of patients with scores that decreased at four weeks.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2020-03-31

Participant Flow

Participant milestones

Measure	Ceftriaxone ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Placebo Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Ceftriaxone ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Placebo Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
Overall Study Adverse Event	0	2

Baseline Characteristics

Ceftriaxone in the Management of Bipolar Depression

Baseline characteristics by cohort

Measure	Ceftriaxone n=2 Participants ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Placebo n=3 Participants Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.	Total n=5 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: only participants with complete data at 4 weeks were analyzed

Number of patients with scores that decreased at four weeks.

Outcome measures

Measure	Ceftriaxone n=2 Participants ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Placebo n=1 Participants Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.	2 participants	1 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: These data were not collected.

Number of patients with scores that decreased at four weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: only participants with complete data at 4 weeks were analyzed

Outcome measures

Measure	Ceftriaxone n=2 Participants ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Placebo n=1 Participants Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.	0 participants	0 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: only participants with complete data at 4 weeks were analyzed

The number of patients that had a decrease on MADRS at 4 weeks.

Outcome measures

Measure	Ceftriaxone n=2 Participants ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Placebo n=1 Participants Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.	2 participants	0 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: only patients with complete data at 4 weeks were analyzed

The number of patients that had a decrease on CGI-BP at 4 weeks.

Outcome measures

Measure	Ceftriaxone n=2 Participants ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Placebo n=1 Participants Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).	2 participants	1 participants

Adverse Events

Ceftriaxone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ceftriaxone n=2 participants at risk ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.	Placebo n=3 participants at risk Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
General disorders Drowsiness	50.0% 1/2 • Number of events 1 • Up to 4 weeks.	33.3% 1/3 • Number of events 1 • Up to 4 weeks.
General disorders Difficulty Concentrating	100.0% 2/2 • Number of events 2 • Up to 4 weeks.	66.7% 2/3 • Number of events 2 • Up to 4 weeks.
Musculoskeletal and connective tissue disorders Poor Coordination	0.00% 0/2 • Up to 4 weeks.	33.3% 1/3 • Number of events 1 • Up to 4 weeks.
Gastrointestinal disorders Diarrhea	0.00% 0/2 • Up to 4 weeks.	33.3% 1/3 • Number of events 1 • Up to 4 weeks.
Psychiatric disorders Nightmares	50.0% 1/2 • Number of events 1 • Up to 4 weeks.	0.00% 0/3 • Up to 4 weeks.
General disorders Dry Mouth	50.0% 1/2 • Number of events 1 • Up to 4 weeks.	0.00% 0/3 • Up to 4 weeks.
Nervous system disorders Tremors	50.0% 1/2 • Number of events 1 • Up to 4 weeks.	0.00% 0/3 • Up to 4 weeks.

Additional Information

Dr. Gerard Sanacora

Yale University Department of Psychiatry

Phone: (203) 974-7535

Email: gerard.sanacora@yale.edu

Results disclosure agreements

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