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NCT00663039 · ClinicalTrials.gov registry record · Phase 2

Effects of Oxytocin Nasal Spray on Social Affiliation

A Phase 2 study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
Phase 2
Development phase
27
Enrollment target

NCT00663039 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 27 participants.

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The verdict

NCT00663039, a Phase 2 study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
Phase 2
Development phase
27 participants
Enrollment target

Study Summary

Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms. These heritable physiological deficits are often found in the biological relatives of schizophrenia proband; particularly those who have schizophrenia related personality styles \[defined by schizophrenia spectrum personalities (SSP) in the diagnostic system\], even though they do not have the full-blown illness. The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response, and the lack of generalized deficits causing problems with task comprehension/engagement that may mute the therapeutic signal. In addition, finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights. This is because about 25% of subjects with schizophrenia spectrum personality disorders experience serious functional impairments. Oxytocin is an extensively used drug, which is well tolerated with few serious side effects. Several lines of evidence suggest its putative role in the treatment of negatives symptoms, particularly a lack of social drive and related symptoms.

Interventions

  • DRUG Placebo
  • DRUG Oxytocin

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2009-10
Est. Completion 2015-07
Phase Phase 2

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT00663039

The ClinicalTrials.gov registry entry for NCT00663039 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00663039 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00663039 about?

NCT00663039 is a clinical study titled "Effects of Oxytocin Nasal Spray on Social Affiliation". Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strateg...

What is the current status of trial NCT00663039?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2009-10. Estimated completion is 2015-07.

What interventions are being tested in trial NCT00663039?

The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG).

Who is sponsoring clinical trial NCT00663039?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.