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NCT00884897 · ClinicalTrials.gov registry record · Phase 2
Oxytocin and Social Cognition in Schizophrenia
A Phase 2 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT00884897: Completed Phase 2 study, sponsored by University of Maryland, Baltimore.
NCT00884897 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00884897, a Phase 2 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions. Social cognition is associated with functional outcome, an important step in striving for recovery in this population. The hormone and neurotransmitter, oxytocin, which has been associated with social bonding and trust has been shown to improve measures of some aspects of social cognition in humans. The study will assess the effect of acute administration of intranasal oxytocin on measures of social cognition and functioning as well as on emotional intelligence and symptoms. Study population: The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups). Experimental design and methods: After a one week lead in phase, participants will undergo 3 weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their existing medication regimen. Outcome measures will be administered during the lead in phase, and at the end of the study drug administration phase (under the acute effect of OT). The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating from the domains of social cognition (emotion perception, attributional style, theory of mind and social perception), symptom rating and measures of social anxiety and quality of life. Side effects and symptoms will be measured weekly.
Primary Outcome
Mayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score th
Interventions
- DRUG Placebo
- DRUG Oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT00884897 record still lists
NCT00884897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00884897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00884897 about?
NCT00884897 is a clinical study titled "Oxytocin and Social Cognition in Schizophrenia". Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions. Social cognition is associated with functional outcome, an important step in striving for rec...
What is the current status of trial NCT00884897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2010-01. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00884897?
The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT00884897?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00884897's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 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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