Status:
COMPLETED
Effects of Oxytocin Nasal Spray on Social Affiliation
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positiv...
Detailed Description
The current study will examine the effects of intranasal oxytocin on physiological/cognitive markers of negative symptoms in 24 participants with schizophrenia spectrum traits. Subjects will be tested...
Eligibility Criteria
Inclusion
- Male/Female subjects between ages of 18-64 years
- The presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
- The presence of visuo-spatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
- Relative of an individual with schizophrenia, schizo-affective, or schizophreniform disorder
- Able to provide written informed consent. Females are excluded due to risk of discomfort and unblinding due to potential uterine cramps induced by oxytocin.
Exclusion
- Subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
- Subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
- Medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
- Received any investigational drug in the preceding four weeks.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00663039
Start Date
October 1 2009
End Date
July 1 2015
Last Update
September 9 2019
Active Locations (1)
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1
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228