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NCT01752712 · ClinicalTrials.gov registry record · NA

Oxytocin and CBSST for People With Schizophrenia

A NA study of Schizophrenia and Schizoaffective Disorder, sponsored by University of Maryland, Baltimore.

Completed
Registry status
NA
Development phase
83
Enrollment target
2
Study locations

NCT01752712 is a NA study of Schizophrenia and Schizoaffective Disorder that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 83 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01752712, a NA study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
NA
Development phase
83 participants
Enrollment target
2
Study locations

Study Summary

A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others, which may reflect social aversion secondary to defeatist beliefs; decreased motivation for social interactions; and/or impairment in the normal reinforcement value of social interactions. These impairments in social function have been shown to be associated with social skill deficits; and decreased ability to identify and remember emotional facial expressions and empathize with the emotional status of others. Unfortunately, pharmacological interventions have limited benefits for impaired social function, whereas psychosocial interventions provide only partial benefit for this critical aspect of the illness. The development of an effective intervention for functional outcomes remains a central therapeutic challenge. Cognitive Behavioral Social Skills Training (CBSST) uses corrective feedback and reinforcement provided by successful interactions to challenge and reduce defeatist performance beliefs that contribute to low drive and interfere with social functioning. CBSST has been shown to have modest effects on social function in people with schizophrenia. Oxytocin plays a critical role in the regulation of normal social affiliative behavior; it is hypothesized to enhance social affiliation through the reduction of anxiety or social risk aversion; the enhancement of motivation for prosocial approach behavior; and/or increased modulation of the salience and processing of social cues. People with schizophrenia have decreased oxytocin levels, which are associated with an impaired ability to identify facial emotions and decreased prosocial behaviors. The study will be comprised of three phases: 1) 2-week Evaluation Phase; 2) 24-week Double-blind Treatment Phase; and 3) 3-month Follow-up Phase.

Interventions

  • DRUG CBSST + Oxytocin
  • DRUG CBSST + Placebo

Study Locations (2)

California

  • University of California, San Diego - San Diego

Maryland

  • Maryland Psychiatric Research Center - Baltimore

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2014-01
Est. Completion 2016-08
Phase NA

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT01752712

The ClinicalTrials.gov registry entry for NCT01752712 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (62% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which CBSST + Oxytocin is the first listed.

NCT01752712 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Maryland.

Frequently Asked Questions

What is clinical trial NCT01752712 about?

NCT01752712 is a clinical study titled "Oxytocin and CBSST for People With Schizophrenia". A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others, which may reflect social aversion secondary to defeatist beliefs; decreased motivation for social interactions; and/or impairment in the normal reinforcement value of social in...

What is the current status of trial NCT01752712?

This trial is currently completed. It is a NA study. The enrollment target is 83 participants. The study started on 2014-01. Estimated completion is 2016-08.

What conditions does trial NCT01752712 study?

This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder.

What interventions are being tested in trial NCT01752712?

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

Who is sponsoring clinical trial NCT01752712?

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

Where is trial NCT01752712 being conducted?

This trial has 2 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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