Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation(SAPPHIRE Study)
This study is currently recruiting participants.
Verified February 2013 by Durham VA Medical Center
Sponsor:
Durham VA Medical Center
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00560677
First received: November 19, 2007
Last updated: February 19, 2013
Last verified: February 2013
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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:
Biospecimen Retention: Samples With DNA
Detailed Description:
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) |
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:
- 18-72 years of age, any ethnic group, either sex.
- Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder.
- Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Exclusion Criteria:
- Unstable current medical or neurological illness.
- Significant suicidal or homicidal ideation.
- Pregnant women or women who could be pregnant.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560677
Contacts
| Contact: Jennifer Naylor, PhD | 919 286-0411 ext 7722 | naylorjc@duke.edu |
Locations
| United States, North Carolina | |
| Durham VAMC | Recruiting |
| 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: | February 19, 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 Stress Disorders, Post-Traumatic Schizophrenia and Disorders with Psychotic Features |
Mental Disorders Stress Disorders, Traumatic Anxiety Disorders |
ClinicalTrials.gov processed this record on May 21, 2013