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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00560677
First received: November 19, 2007
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition
Schizophrenia
PTSD

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • Brief Assessment of Cognition in Schizophrenia (BACS) [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Serum and cells collected.


Estimated Enrollment: 400
Study Start Date: March 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Veterans with schizophrenia or schizoaffective disorder.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560677

Locations
United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Christine E Marx, MD, MA Durham VAMC
  More Information

No publications provided

Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT00560677     History of Changes
Other Study ID Numbers: VA IRB# 01175, VA IRB# 01175
Study First Received: November 19, 2007
Last Updated: October 15, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Durham VA Medical Center:
Schizophrenia
PTSD
Cognition

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 29, 2014