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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01092598
Other study ID # H54355-35547-O1
Secondary ID
Status Completed
Phase N/A
First received March 23, 2010
Last updated May 26, 2015
Start date March 2010
Est. completion date May 2015

Study information

Verified date May 2015
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Older adults with schizophrenia are a growing segment of the population yet their physical health status is poor. In order to design effective interventions, the contributing factors must be understood. Current data suggest the side effects of psychiatric medications, sociodemographic factors, and health care disparities are a few of the reasons for the poor physical health. There are only limited data on the impact of psychiatric symptomatology and neurocognition on the physical health of this population. These limited data indicate that worse symptomatology and poorer neurocognition may negatively impact physical functioning, a critical component to optimal physical health. The purpose of this pilot study is to begin to fill this knowledge gap by: 1. examining the relationship between neurocognitive function and physical function and 2. Examining the relationship between schizophrenia symptoms and physical function. 3. Examining the relationship between serum Brain Derived Neurotrophic Factor (BDNF) and physical function. Using a descriptive correlational design, 50 older adults (55+) with schizophrenia or schizoaffective disorder will be assessed. Bivariate associations will be used to examine the relationship between key variables including schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS), neurocognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB), Physical Function as measured objectively by the Timed Get Up and Go (TGUG) test and subjectively with the physical component summary subscale of the 12-item short form health survey (SF-12), and serum BDNF. These pilot data will lay the foundation for a future health promoting intervention.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date May 2015
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- English speaking adults older than or equal to 55 with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder that pass a capacity to consent test based on comprehension of the consent form.

Exclusion Criteria:

- Non-English speaking,

- Adults younger than 55,

- No diagnosis of schizophrenia of schizoaffective disorder, and/or

- Not passing a capacity to consent test.

Study Design

Time Perspective: Cross-Sectional


Locations

Country Name City State
United States UCSF San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Function enrollment No
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