Status:
ENROLLING_BY_INVITATION
Psychiatric Genotype/Phenotype Project Repository
Lead Sponsor:
Vanderbilt University
Conditions:
Depressive Disorder, Major
Bipolar Disorder
Eligibility:
All Genders
16-65 years
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 psycho...
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 majo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00762866
Start Date
September 1 2008
End Date
December 1 2027
Last Update
February 11 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212