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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 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 39 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01568528
The ClinicalTrials.gov registry entry for NCT01568528 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01568528 reports 0 study locations.
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.
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