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NCT01568528 · ClinicalTrials.gov registry record · Phase 2
Oxytocin as Adjunctive Treatment of Schizophrenia
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT01568528: Completed Phase 2 study, sponsored by Emory University.
NCT01568528 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01568528, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
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.
Primary Outcome
In order to assess the processing of social stimuli, subjects will be presented with a series of human faces of mixed sex and race showing neutral emotions and instructed to visually scan each face. Six regions of interest (ROIs) will be defined for each face stimulus: eyes, nose mouth, forehead, cheeks, and outside the contours of the face. The data will be processed off line for each face stimulus as the total time of fixation inside each of the ROIs. Refers to the number of fixations that occ
Interventions
- DRUG Placebo
- OTHER Control
- DRUG Oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-03 |
| Est. Completion | 2017-03-15 |
| Phase | Phase 2 |
What the finished NCT01568528 record still lists
NCT01568528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01568528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01568528 about?
NCT01568528 is a clinical study titled "Oxytocin as Adjunctive Treatment of Schizophrenia". 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 prosoci...
What is the current status of trial NCT01568528?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2013-03. Estimated completion is 2017-03-15.
What interventions are being tested in trial NCT01568528?
The interventions under investigation include: Placebo (DRUG), Control (OTHER), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT01568528?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01568528's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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