The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute being on adequate treatment with antipsychotic medication.
Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
14
Oxytocin: 24IU - 168 IU
placebo drug
UCSD Medical Center - Hillcrest
San Diego, California, United States
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks
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.
Time frame: baseline and 28 weeks
Global Assessment of Functioning (GAF)
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).
Time frame: 28 weeks
Clinical Global Impression-Severity
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).
Time frame: 28 Weeks
Clinical Global Impression-Global Improvement (CGI-I)
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).
Time frame: 28 Weeks
Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)
Time frame: 28 weeks
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
Time frame: 28 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.