Trial Outcomes & Findings for A Placebo-controlled Efficacy Study of IV Ceftriaxone for Refractory Psychosis (NCT NCT00591318)

Last Updated: 2022-12-02

Results Overview

Positive and Negative Syndrome Scale (PANSS) - 7 point scale where 1 is absent and 7 is extreme The positive scale has 7 items. Altogether there are 7 items for the total score (range is a minimum of 7 to a maximum of 49). Lower scores indicate better health. We report the Positive scale

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Last observation assessed occurring from baseline through to the end of week 8

Results posted on

2022-12-02

Participant Flow

There were 12 people who signed consent but 2 opted not to start treatment and therefore are not included in the demographics or the treatment results report

Participant milestones

Participant milestones
Measure	IV Ceftriaxone IV Ceftriaxone 2 grams/day ceftriaxone: 2 grams of ceftriaxone given daily, Monday to Friday, excluding major holidays, for a total of 40 doses	IV Placebo IV Placebo (Normal Saline) Normal Saline: 50 cc of normal saline, daily, Monday through Friday, except for major holidays, for a total of 40 normal saline infusions.
Overall Study STARTED	5	5
Overall Study COMPLETED	1	5
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IV Ceftriaxone IV Ceftriaxone 2 grams/day ceftriaxone: 2 grams of ceftriaxone given daily, Monday to Friday, excluding major holidays, for a total of 40 doses	IV Placebo IV Placebo (Normal Saline) Normal Saline: 50 cc of normal saline, daily, Monday through Friday, except for major holidays, for a total of 40 normal saline infusions.
Overall Study Lack of Efficacy	2	0
Overall Study Adverse Event	2	0

Baseline Characteristics

A Placebo-controlled Efficacy Study of IV Ceftriaxone for Refractory Psychosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceftriaxone n=5 Participants Ceftriaxone Group (n=5)	Placebo n=5 Participants Placebo Group (n=5)	Total n=10 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 12.5 • n=5 Participants	38.6 years STANDARD_DEVIATION 11.7 • n=7 Participants	40.5 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 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
PANSS Positive	16.7 score on a scale STANDARD_DEVIATION 4.9 • n=5 Participants	18.2 score on a scale STANDARD_DEVIATION 4.9 • n=7 Participants	17.3 score on a scale STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: Last observation assessed occurring from baseline through to the end of week 8

Population: We included all 10 people who started treatment. We used the last observation carried forward in the final analysis which included all time points from baseline through to the end of week 8.

Outcome measures

Outcome measures
Measure	Ceftriaxone Arm Results n=5 Participants This group was randomized to 2 gms of ceftriaxone given 5 days/week for 8 weeks. If participants were not at least 15% improved at 6 weeks, they were considered unlikely to respond and rated as having completed the randomized phase of treatment.	Placebo Arm Results n=5 Participants This group was randomized to receive saline given 5 days/week for 8 weeks
Positive and Negative Syndrome Scale - Positive Subscale	17.6 score on a scale Standard Deviation 4.9	18.6 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Last observation assessed occurring from baseline through to the end of week 8

Population: All 9 participants had ratings on this scale which were used for the results below. One placebo participant (the missing one of the 10) only had a rating at baseline and so was not included in the analysis.

Scale evaluates positive symptoms of psychosis rated on a scale of 0-5 for each of the 34 items (0 for absent and 5 for severe). Minimum score is 0 and the maximum score is 170; higher scores are worse.

Outcome measures

Outcome measures
Measure	Ceftriaxone Arm Results n=5 Participants This group was randomized to 2 gms of ceftriaxone given 5 days/week for 8 weeks. If participants were not at least 15% improved at 6 weeks, they were considered unlikely to respond and rated as having completed the randomized phase of treatment.	Placebo Arm Results n=4 Participants This group was randomized to receive saline given 5 days/week for 8 weeks
Scale for the Assessment of Positive Symptoms	27.8 score on a scale Standard Deviation 15.1	22.7 score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: Last observation assessed occurring from baseline through to the end of week 8

Population: 5 in the ceftriaxone group and 4 in the placebo group had ratings on this scale

This is a clinician-administered scale of depression severity with 17 items with scores ranging from 0-7 with higher scores indicating greater severity of depression. The range is 0-119, where higher scores indicate greater depression

Outcome measures

Outcome measures
Measure	Ceftriaxone Arm Results n=5 Participants This group was randomized to 2 gms of ceftriaxone given 5 days/week for 8 weeks. If participants were not at least 15% improved at 6 weeks, they were considered unlikely to respond and rated as having completed the randomized phase of treatment.	Placebo Arm Results n=4 Participants This group was randomized to receive saline given 5 days/week for 8 weeks
Hamilton Depression Scale	15.4 score on a scale Standard Deviation 12.7	7.7 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Last observation assessed occurring from baseline through to the end of week 8

Population: Results from the analysis of data on all 10 participants are presented below

The Hamilton Anxiety Rating Scale is a clinician-administered scale of 14 items, with each item rated 0-4 where 4 is the most severe. The range is 0-56 where the higher values indicate greater anxiety.

Outcome measures

Outcome measures
Measure	Ceftriaxone Arm Results n=5 Participants This group was randomized to 2 gms of ceftriaxone given 5 days/week for 8 weeks. If participants were not at least 15% improved at 6 weeks, they were considered unlikely to respond and rated as having completed the randomized phase of treatment.	Placebo Arm Results n=5 Participants This group was randomized to receive saline given 5 days/week for 8 weeks
Hamilton Anxiety Rating Scale	6.2 score on a scale Standard Deviation 5.4	5.8 score on a scale Standard Deviation 2.2

Adverse Events

Ceftriaxone

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ceftriaxone n=5 participants at risk Participants randomized to Ceftriaxone	Saline n=5 participants at risk Participants randomized to saline
Psychiatric disorders Prolongation of hospitalization	20.0% 1/5 • Number of events 1 • Adverse events are reported that occurred during the time period of each participants receipt of randomized treatment (ranging to a maximum of 8 weeks)	0.00% 0/5 • Adverse events are reported that occurred during the time period of each participants receipt of randomized treatment (ranging to a maximum of 8 weeks)

Other adverse events

Other adverse events
Measure	Ceftriaxone n=5 participants at risk Participants randomized to Ceftriaxone	Saline n=5 participants at risk Participants randomized to saline
Skin and subcutaneous tissue disorders Rash	60.0% 3/5 • Number of events 3 • Adverse events are reported that occurred during the time period of each participants receipt of randomized treatment (ranging to a maximum of 8 weeks)	20.0% 1/5 • Number of events 1 • Adverse events are reported that occurred during the time period of each participants receipt of randomized treatment (ranging to a maximum of 8 weeks)
Gastrointestinal disorders Diarrhea	40.0% 2/5 • Number of events 2 • Adverse events are reported that occurred during the time period of each participants receipt of randomized treatment (ranging to a maximum of 8 weeks)	0.00% 0/5 • Adverse events are reported that occurred during the time period of each participants receipt of randomized treatment (ranging to a maximum of 8 weeks)
Skin and subcutaneous tissue disorders Pain	20.0% 1/5 • Number of events 1 • Adverse events are reported that occurred during the time period of each participants receipt of randomized treatment (ranging to a maximum of 8 weeks)	0.00% 0/5 • Adverse events are reported that occurred during the time period of each participants receipt of randomized treatment (ranging to a maximum of 8 weeks)

Additional Information

Brian Fallon

New York State Psychiatric Institute

Phone: 646-774-8052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place