Psychiatric Genotype/Phenotype Project Repository (PGPP)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Stephan Heckers, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00762866
First received: September 26, 2008
Last updated: June 16, 2013
Last verified: June 2013
  Purpose

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.


Condition
Depressive Disorder, Major
Bipolar Disorder
Psychotic Disorders

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Weeks
Official Title: Psychiatric Genotype/Phenotype Project

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Biospecimen Retention:   Samples With DNA

Blood, urine, saliva


Estimated Enrollment: 300
Study Start Date: September 2008
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Outpatient Mental Health Clinic, Inpatient Psychiatric Hospital, Research Volunteers

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)
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762866

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Stephan Heckers, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Stephan Heckers, Chair of the Department of Psychiatry, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00762866     History of Changes
Other Study ID Numbers: 080606
Study First Received: September 26, 2008
Last Updated: June 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Major Depressive Disorder
Depression
Bipolar I Disorder
Bipolar II Disorder
Bipolar Disorder NOS
Psychotic Disorder
Schizophrenia
Schizoaffective Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Psychotic Disorders
Mental Disorders
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 17, 2014