Psychiatric Genotype/Phenotype Project Repository

NCT ID: NCT00762866

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Depressive Disorder, Major; Bipolar Disorder; Psychotic Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

MDD

Unipolar Major Depressive Disorder, any subtype

No interventions assigned to this group

Bipolar

Bipolar I or II Disorder or Bipolar Disorder NOS

No interventions assigned to this group

Psychosis

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

No interventions assigned to this group

Eligibility Criteria

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)

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Stephan Heckers

Chair of the Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan Heckers, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

080606

Identifier Type: -

Identifier Source: org_study_id