Depressive Disorder, MajorPGPPNCT00762866
Psychiatric Genotype/Phenotype Project Repository
An observational study of Depressive Disorder, Major and Bipolar Disorder, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major, Bipolar Disorder, Psychotic Disorders
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2027
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Outpatient Mental Health Clinic, Inpatient Psychiatric Hospital, Research Volunteers
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: 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.
Read the 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.
- Keywords
- Major Depressive Disorder, Depression, Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, Psychotic Disorder, Schizophrenia, Schizoaffective Disorder
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Psychotic Disorders, Depression, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain volume
Observational neuromaging study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Heckers, Vanderbilt University
- Investigators
- Stephan Heckers, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762866
- Sponsor's protocol ID
- 080606
- Acronym
- PGPP
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2008
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Genotype/Phenotype Project
- ClinicalTrials.gov ID
- NCT00762866
- Acronym / sponsor ID
- PGPP / 080606
- Keywords
- Major Depressive Disorder, Depression, Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, Psychotic Disorder, Schizophrenia, Schizoaffective Disorder
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatient Mental Health Clinic, Inpatient Psychiatric Hospital, Research Volunteers
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (12 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain volume
Time frame: 2 years
Observational neuromaging study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan Heckers, M.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major and Bipolar Disorder, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain volume (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.