Psychiatric Genotype/Phenotype Project Repository

Bipolar Disorder Clinical Trial

— PGPP  

Official title:

Psychiatric Genotype/Phenotype Project

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00762866
• Other study ID #: 080606
• Status: Enrolling by invitation
• Start date: September 2008
• Est. completion date: December 2027

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Mental Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain volume	Observational neuromaging study	2 years