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Enrolling by Invitation

NCT Number: NCT00762866

Psychiatric Genotype/Phenotype Project Repository

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.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between the ages of 16 and 65
  • Able and willing to provide informed consent
  • Able to read and speak English sufficiently to provide consent and answer questions
  • 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

  • Reported pregnancy or breastfeeding
  • Dementia or delirium
  • 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)
  • Exclusion criteria for normal control subjects include any history of mental illness or psychotropic drug abuse.
  • 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.

Treatment and study plan

Primary outcomes

  1. Brain volume

    Time frame: 2 years

    Observational neuromaging study

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Psychiatric Genotype/Phenotype Project

Acronym: PGPP

Important dates

Study start
2008
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2008
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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