Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia

Open-label Study of the Long-Term Efficacy of Intranasal Oxytocin in Patients With Schizophrenia

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02144155

Enrollment

Registered

2014-05-21

Start date

2012-03-31

Completion date

2014-12-31

Last updated

2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Oxytocin

Brief summary

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.

Detailed description

Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.

Interventions

DRUGOxytocin: 24IU - 168 IU

Oxytocin: 24IU - 168 IU

DRUGPlacebo

placebo drug

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adult men or women, 18 years of age or older. 2. Meet DSM-IV criteria for Schizophrenia 3. Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study. 4. Must be on a therapeutic dose of 1 or 2 atypical antipsychotic medications (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks. 5. A minimum PANSS total score of 55 at baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening. 6. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline; 7. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent. 8. Must be able to use nasal spray 9. Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.

Exclusion criteria

1. Are pregnant or are breastfeeding (negative pregnancy test at screening) 2. A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse 3. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study 4. Are unsuitable in any way to participate in this study, in the opinion of the investigator. 5. Another current, primary DSM-IV diagnosis other than Schizophrenia

Design outcomes

Primary

Measure	Time frame	Description
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks	baseline and 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.

Secondary

Measure	Time frame	Description
Global Assessment of Functioning (GAF)	28 weeks	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).
Clinical Global Impression-Severity	28 Weeks	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).
Clinical Global Impression-Global Improvement (CGI-I)	28 Weeks	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).
Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)	28 weeks	—
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)	28 Weeks	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	14
Total	14

Baseline characteristics

Characteristic	—	All Participants
Age, Continuous	— years	—
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants
Race (NIH/OMB) Asian	—	0 Participants
Race (NIH/OMB) Black or African American	—	7 Participants
Race (NIH/OMB) More than one race	—	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants
Race (NIH/OMB) Unknown or Not Reported	—	2 Participants
Race (NIH/OMB) White	—	5 Participants
Sex: Female, Male Female	—	6 Participants
Sex: Female, Male Male	—	8 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 14
other Total, other adverse events	0 / 14
serious Total, serious adverse events	0 / 14

Outcome results

Primary

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