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Completed Phase 2 Interventional Results available

Effects of Oxytocin Nasal Spray on Social Affiliation

ClinicalTrials.gov ID: NCT00663039

Public ClinicalTrials.gov record NCT00663039. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00663039
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
27 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2009
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015
Last update posted
Sep 8, 2019

2009 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Maryland Psychiatric Research Center Catonsville Maryland 21228

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00663039, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 8, 2019 · Synced Sep 2, 2026

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