Psychiatric Genotype/Phenotype Project Repository

NCT00762866 | Enrolling By Invitation

• 1 other identifier: 080606
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Depressive Disorder, Major; Psychotic Disorders

Keywords

Major Depressive Disorder; Depression; Bipolar I Disorder; Bipolar II Disorder; Bipolar Disorder NOS; Psychotic Disorder; Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Brain volume

  Observational neuromaging study

  2 years

Study Arms (3)

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

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient Mental Health Clinic, Inpatient Psychiatric Hospital, Research Volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, saliva

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Psychotic Disorders; Depression; Schizophrenia

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Behavior

Study Officials

• Stephan Heckers, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Psychiatry

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2008
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)