Oxytocin as Adjunctive Treatment of Schizophrenia
Completed · Phase 2 · Has a placebo group
Conditions studied: Schizophrenia
In brief
The focus of the current project is to advance our understanding of the effects of oxytocin (OT) on components of social cognition in schizophrenia (SCZ). Despite the rapid increase in our understanding of the role of OT in rodent models of social behavior and an explosion of interest in the prosocial effects of OT in healthy controls, little work has been done to dissect the potential effects of OT on SCZ subjects with social deficits. Social deficits are a crucial aspect of the functional impairments that limit the rehabilitation of patients with SCZ. In particular, SCZ patients with enduring negative symptoms (deficit syndrome, Kirkpatrick et al. 1989) have prominent social deficits as a core feature of this subtype of the illness. Our currently available medications do very little to improve these social deficits. Hence it is of utmost public health importance to address the knowledge gap regarding the potential of OT to improve social function in this illness. Intact social function depends on the competent functioning of several cognitive domains that subserve perception of social cues and the generation of motivated social behavior. We propose to conduct a pharmacological challenge study of OT vs. placebo administration to study the effects of OT on specific components of social cognition in male deficit syndrome SCZ subjects. Primary Hypothesis: Intranasal OT will improve social cognition in subjects with deficit syndrome SCZ.
Key facts
- Study ID
- NCT01568528
- Run by
- Emory University
- People needed
- 39
- Starts
- 2013-03-01
- Expected to finish
- 2017-03-15
- Last updated by the study team
- 2019-09-04
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Male
- Ages 18-65
- Exclusion Criteria:
- Female
- History of a psychotic disorder, or depression requiring medication
- Active substance abuse or dependence within the prior 30 days
- Medical admission within the past six months
- Criteria to rule out subjects with medical problems likely to present a confound:
- Known HIV infection or AIDS
- History of TBI
- Seizure disorder
- Known Alzheimer's Disease or other dementia
- Minimal cognitive impairment (MCI)
- Parkinson's Disease
- Unstable medical condition
You may not qualify if…
- Female sex
- History of bipolar disorder
- Active substance dependence within the prior 30 days (cigarette smoking is allowed)
- Has had a psychiatric hospitalization in the 8 weeks prior to consent.
- Suicidal or homicidal ideation in the previous six months
- Subjects who have answered 'yes' to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-Suicide Severity Rating Scale, C-SSRS, or who have answered 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" portion shall be excluded from the study if ideation or behavior occurred within one month of consent. Subjects excluded for this reason will be referred for appropriate treatment.
- History of mental retardation or pervasive developmental disorder
- History of neurological disorder (e.g., traumatic brain injury, seizure disorder, Parkinson's Disease, dementia), loss of consciousness for more than 10 minutes due to head trauma, known HIV infection, or AIDS
- Treatment with a benzodiazepine in the two weeks prior to consent.
- Control Participants:
- Inclusion Criteria:
- Male
- Ages 18-65
- Exclusion Criteria:
- Female
- History of a psychotic disorder, or depression requiring medication
- Active substance abuse or dependence within the prior 30 days
- Medical admission within the past six months
- Criteria to rule out subjects with medical problems likely to present a confound:
- Known HIV infection or AIDS
- History of TBI
- Seizure disorder
- Known Alzheimer's Disease or other dementia
- Minimal cognitive impairment (MCI)
- Parkinson's Disease
Where it is running
- Atlanta VA Medical Center — Decatur, Georgia, United States
Full record on ClinicalTrials.gov
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