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NCT00560677 Clinical Trial

Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation(SAPPHIRE Study)

Schizophrenia Clinical Trial

— SAPPHIRE  

Official title:
Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00560677
Other study ID # VA IRB# 01175
Secondary ID VA IRB# 01175
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2007
Est. completion date December 2023

Study information
Verified date August 2021
Source Durham VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We propose to establish a database characterizing the presence or absence of comorbid PTSD in veterans with schizophrenia or schizoaffective disorder (SAD) receiving services at the Durham VA Medical Center. In addition to the evaluation of PTSD symptoms in veterans with schizophrenia or SAD, this database will facilitate the investigation of a number of additional specific research questions relevant to veterans with psychotic disorders.

Description:

See brief summary

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 72 Years
Eligibility Inclusion Criteria: 1. 18-72 years of age, any ethnic group, either sex. 2. Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder. 3. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process. Exclusion Criteria: 1. Unstable current medical or neurological illness. 2. Significant suicidal or homicidal ideation. 3. Pregnant women or women who could be pregnant.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Durham VAMC Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Durham VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brief Assessment of Cognition in Schizophrenia (BACS) The Brief Assessment of Cognition in Schizophrenia (BACS) includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Visit 1
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