Trial Outcomes & Findings for Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia (NCT NCT02144155)
NCT ID: NCT02144155
Last Updated: 2019-12-09
Results Overview
The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances.
TERMINATED
NA
14 participants
baseline and 28 weeks
2019-12-09
Participant Flow
Participant milestones
| Measure |
All Participants
This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PI has left the institution and this study was terminated due to loss of funding. The age of the participants enrolled cannot be located.
Baseline characteristics by cohort
| Measure |
All Participants
n=14 Participants
This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study.
|
|---|---|
|
Sex: Female, Male
Female
|
6 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: baseline and 28 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 WeeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 WeeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 WeeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place