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Psychiatric Genotype/Phenotype Project Repository (PGPP)

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ClinicalTrials.gov Identifier: NCT00762866
Recruitment Status : Enrolling by invitation
First Posted : September 30, 2008
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Stephan Heckers, Vanderbilt University

September 26, 2008
September 30, 2008
February 28, 2018
September 2008
December 2020   (Final data collection date for primary outcome measure)
Brain volume [ Time Frame: 2 years ]
Observational neuromaging study
Not Provided
Complete list of historical versions of study NCT00762866 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Psychiatric Genotype/Phenotype Project Repository
Psychiatric Genotype/Phenotype Project
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.
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.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Cross-Sectional
2 Weeks
Retention:   Samples With DNA
Description:
Blood, urine, saliva
Non-Probability Sample
Outpatient Mental Health Clinic, Inpatient Psychiatric Hospital, Research Volunteers
  • Depressive Disorder, Major
  • Bipolar Disorder
  • Psychotic Disorders
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
300
Same as current
December 2022
December 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00762866
080606
No
Not Provided
Not Provided
Stephan Heckers, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Stephan Heckers, M.D. Vanderbilt University
Vanderbilt University Medical Center
February 2018