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

NCT ID: NCT00560677

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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See brief summary

Conditions

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Schizophrenia PTSD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Durham VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine E Marx, MD, MA

Role: PRINCIPAL_INVESTIGATOR

Durham VAMC

Locations

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Durham VAMC

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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VA IRB# 01175

Identifier Type: -

Identifier Source: secondary_id

VA IRB# 01175

Identifier Type: -

Identifier Source: org_study_id

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