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Psychiatric Genotype/Phenotype Project Repository (PGPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762866
Recruitment Status : Enrolling by invitation
First Posted : September 30, 2008
Last Update Posted : October 25, 2019
Information provided by (Responsible Party):
Stephan Heckers, Vanderbilt University

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
Depressive Disorder, Major Bipolar Disorder Psychotic Disorders

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Weeks
Official Title: Psychiatric Genotype/Phenotype Project
Study Start Date : September 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Unipolar Major Depressive Disorder, any subtype
Bipolar I or II Disorder or Bipolar Disorder NOS
Psychotic Disorder including Schizophrenia, Schizoaffective, Schizophreniform, Brief Psychotic Disorder, and Psychotic Disorder NOS

Primary Outcome Measures :
  1. Brain volume [ Time Frame: 2 years ]
    Observational neuromaging study

Biospecimen Retention:   Samples With DNA
Blood, urine, saliva

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient Mental Health Clinic, Inpatient Psychiatric Hospital, Research Volunteers

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)
  4. Exclusion criteria for normal control subjects include any history of mental illness or psychotropic drug abuse.
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00762866

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
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Principal Investigator: Stephan Heckers, M.D. Vanderbilt University
Additional Information:

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Responsible Party: Stephan Heckers, Chair of the Department of Psychiatry, Vanderbilt University Identifier: NCT00762866    
Other Study ID Numbers: 080606
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Keywords provided by Stephan Heckers, Vanderbilt University:
Major Depressive Disorder
Bipolar I Disorder
Bipolar II Disorder
Bipolar Disorder NOS
Psychotic Disorder
Schizoaffective Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders