Trial Outcomes & Findings for Antipsychotic Effects of Oxytocin (NCT NCT01621737)
NCT ID: NCT01621737
Last Updated: 2019-11-19
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
42 participants
6 weeks
2019-11-19
Participant Flow
The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
Participant milestones
| Measure |
All Participants
The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antipsychotic Effects of Oxytocin
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 6 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: 6 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: 6 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: 6 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: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. It consists of 14 items of which each item is scored 0 (not present) to 4 (very severe).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The PTS is a self-rated scale to assess current paranoia symptoms. The PTS consists of 32 items that the subject rates from 1 (not at all) to 5 (totally).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The TSMQ is a brief questionnaire asking patients about how satisfied they were with the ease, timing, etc. of the study medication giving a good indication of adherence
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The CTQ is a validated measure of adverse early experiences characterized on a measure of Anxiety Sensitivity Index and retrospective childhood maltreatment. A 5-point frequency of occurrence scale is utilized: (1) never true, (2) rarely true, (3) sometimes true, (4) often true, and (5) very often true. Each sub-scale score ranges from 5 (no history of abuse or neglect) to 25 (very extreme history of abuse and neglect).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The ECR is a self-rated questionnaire designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure vs. secure about the extent to which their partner's availability and responsiveness) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others vs. secure depending on others) .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 ("extremely strong", "easily", or "satisfying") to 6 ("absent" or "never") based on how he/she feels at the time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
The ER-40 is a computerized emotion discrimination test presenting 40 color photographs of evoked happy, sad, anger, fear and neutral expressions balanced for poser gender and ethnicity.
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