PGPP: Psychiatric Genotype/Phenotype Project Repository

Sponsor
Vanderbilt University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT00762866
Collaborator
(none)
300
1
231
1.3

Study Details

Study Description

Brief Summary

The purpose of this project is to obtain DNA, brain imaging data, other biological samples (e.g., urine, serum), and a comprehensive clinical assessment on patients with schizophrenia and other psychotic disorders, bipolar disorder, major depression, and normal volunteer controls. Understanding the physical and genetic factors related to these disorders will help us make progress in fitting treatments to an individual's needs. Participants will take part in a detailed clinical assessment, two blood draws, and an MRI scan over two visits. Participants will also be asked to provide urine and saliva samples.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The links between psychiatric symptoms and underlying biological processes remain unclear at this time. Unipolar Major Depressive Disorder, Bipolar Disorder, and Schizophrenia are associated with major disruptions in functioning and quality of life. Understanding the causal physiological and genetic factors involved in each of these disorders would allow us to make great strides in tailoring treatment to the individual's needs. Because the etiology of these disorders are likely multifactorial in nature, a study examining a wide range of variables might best allow us to examine the interactions between different factors and to get a better sense of how genes and the brain interact to produce psychiatric disorder.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Psychiatric Genotype/Phenotype Project
    Study Start Date :
    Sep 1, 2008
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    MDD

    Unipolar Major Depressive Disorder, any subtype

    Bipolar

    Bipolar I or II Disorder or Bipolar Disorder NOS

    Psychosis

    Psychotic Disorder including Schizophrenia, Schizoaffective, Schizophreniform, Brief Psychotic Disorder, and Psychotic Disorder NOS

    Outcome Measures

    Primary Outcome Measures

    1. Brain volume [2 years]

      Observational neuromaging study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Between the ages of 16 and 65

    2. Able and willing to provide informed consent

    3. Able to read and speak English sufficiently to provide consent and answer questions

    4. Diagnosis of one of the following:

    • Unipolar Major Depressive Disorder of any subtype

    • Bipolar I, Bipolar II Disorder, or Bipolar Disorder NOS

    • Axis I Psychotic Disorder, which can include the diagnoses of Schizophrenia, Schizoaffective Disorder, Major Depression or Mania with Psychotic Features, Schizophreniform Disorder, Brief Psychotic Episode, or Psychotic Disorder NOS

    • Normal volunteer controls, individuals with no personal history of any Axis I disorder.

    Exclusion Criteria:
    1. Reported pregnancy or breastfeeding

    2. Dementia or delirium

    3. Any medical condition that would interfere with participation in the study. This would include, but not be limited to:

    • uncontrolled diabetes, hypothyroidism, Cushing's disease, or other significant endocrine condition (treated endocrine condition is allowed)

    • demyelinating disease

    • HIV infection

    • active hepatitis

    • CNS infection

    • clinically significant and unstable cardiovascular disease

    • any cancer involving the CNS (including metastatic disease)

    1. Exclusion criteria for normal control subjects include any history of mental illness or psychotropic drug abuse.

    2. Participants will be excluded from the imaging portion of the study if they have any condition deemed to interfere with PET or MRI scanning, such as but not restricted to extreme obesity, metal fragments in eyes, metal implants in the head, or cochlear implant. These participants may still take part in the portion of the study involving the clinical assessment and providing biological samples.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University Medical Center Nashville Tennessee United States 37212

    Sponsors and Collaborators

    • Vanderbilt University

    Investigators

    • Principal Investigator: Stephan Heckers, M.D., Vanderbilt University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephan Heckers, Chair of the Department of Psychiatry, Vanderbilt University
    ClinicalTrials.gov Identifier:
    NCT00762866
    Other Study ID Numbers:
    • 080606
    First Posted:
    Sep 30, 2008
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021

    Study Results

    No Results Posted as of Dec 8, 2021