Trial Outcomes & Findings for Sodium Nitroprusside in Early Course Schizophrenia (NCT NCT04986072)

NCT ID: NCT04986072

Last Updated: 2025-12-30

Results Overview

Comparing total, positive, and negative scores between SNP and Placebo

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Measured at hour 2

Results posted on

2025-12-30

Participant Flow

study terminated sue to low recruitment

Participant milestones

Participant milestones
Measure
Sodium Nitroprusside Arm
Sodium Nitroprusside (0.5 μg/kg/min) for 4 hours Sodium Nitroprusside: Half of participants will receive Intravenous Sodium Nitroprusside (0.5 μg/kg/min) for 4 hours.
Placebo Arm
5% Dextrose (0.5 μg/kg/min) for 4 hours 5% Dextrose solution: Half of participants will receive intravenous 5% Dextrose solution for 4 hours.
Overall Study
STARTED
0
1
Overall Study
COMPLETED
0
1
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sodium Nitroprusside in Early Course Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sodium Nitroprusside Arm
Sodium Nitroprusside (0.5 μg/kg/min) for 4 hours Sodium Nitroprusside: Half of participants will receive Intravenous Sodium Nitroprusside (0.5 μg/kg/min) for 4 hours.
Placebo Arm
n=1 Participants
5% Dextrose (0.5 μg/kg/min) for 4 hours 5% Dextrose solution: Half of participants will receive intravenous 5% Dextrose solution for 4 hours.
Total
n=1 Participants
Total of all reporting groups
Age, Customized
Due to privacy concerns of single participant, data will not be shown for this outcome
NA Participants
n=166 Participants
NA Participants
n=167 Participants
Sex/Gender, Customized
Due to privacy concerns of single participant, data will not be shown for this outcome
NA Participants
n=166 Participants
NA Participants
n=167 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=166 Participants
0 Participants
n=167 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=166 Participants
0 Participants
n=167 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=166 Participants
1 Participants
n=167 Participants
Region of Enrollment
United States
1 participants
n=166 Participants
1 participants
n=167 Participants
PANSS Total Score
NA score on scale
n=166 Participants
0 score on scale
n=167 Participants

PRIMARY outcome

Timeframe: Measured at hour 2

Population: Due to privacy concerns of single participant, data will not be shown for this outcome

Comparing total, positive, and negative scores between SNP and Placebo

Outcome measures

Outcome data not reported

Adverse Events

Sodium Nitroprusside Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Arm

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. Paulo Lizano MD, PhD

University of Rochester Medical Center

Phone: (201) 776-6708

Results disclosure agreements

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