NCT00560677

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

16.8 years

First QC Date

November 19, 2007

Last Update Submit

August 16, 2021

Conditions

SchizophreniaPTSD

Keywords

SchizophreniaPTSDCognition

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans with schizophrenia or schizoaffective disorder.

You may qualify if:

  • 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.

You may not qualify if:

  • Unstable current medical or neurological illness.
  • Significant suicidal or homicidal ideation.
  • Pregnant women or women who could be pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VAMC

Durham, North Carolina, 27705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and cells collected.

MeSH Terms

Conditions

SchizophreniaStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Christine E Marx, MD, MA

    Durham VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

US(1)