Psychotic DisordersNCT00691535
Genetics of Symptomatology and Treatment Response in Psychotic Major Depression
An observational study of Psychotic Disorders and Depressive Disorder, run by Stanford University at 1 site in United States.
Trial summary
We hope to learn more about the biology of psychiatric illness with the hope of improving the diagnosis and treatment of such psychiatric conditions as major depression. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders, Depressive Disorder, Depressive Disorder, Major
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- You are currently experiencing symptoms that are consistent with an episode of major depression without symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or
- You are currently experiencing symptoms that are consistent with an episode of major depression with symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or
- You have been diagnosed with either schizophrenia or schizoaffective disorder, or
- You are a volunteer without a history of psychiatric illness (a healthy control subject).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Association of BDNF, COMT, MDRI, CRH, CRF, and GC Receptor Genetic Polymorphisms With Symptomatology and Treatment Response in Psychotic Major Depression
We hope to learn more about the biology of psychiatric illness with the hope of improving the diagnosis and treatment of such psychiatric conditions as major depression.
Read the detailed description
From the blood sample you donate, the researchers will obtain DNA. This DNA will be used to search for DNA markers related to the underlying biology of psychiatric illness and how this might explain the symptoms of these disorders. Research using DNA is an important way to try to understand human disease and/or the role genes play in disease. In effect, part of your blood sample will be used to attempt to understand how genetic factors contribute to the symptoms of such psychiatric conditions as major depression.
- Medical subject headings
- Psychotic Disorders, Depressive Disorder, Depressive Disorder, Major
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startOct 2003
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Other
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Schatzberg, Stanford University
- Investigators
- Alan F Schatzberg, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691535
- Sponsor's protocol ID
- SU-05132008-1160
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2008
- Last updated
- 19 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of BDNF, COMT, MDRI, CRH, CRF, and GC Receptor Genetic Polymorphisms With Symptomatology and Treatment Response in Psychotic Major Depression
- ClinicalTrials.gov ID
- NCT00691535
- Acronym / sponsor ID
- SU-05132008-1160
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2003 (actual)
- Primary completion
- Jun 2012 (actual)
- First posted
- 5 Jun 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.
We hope to learn more about the biology of psychiatric illness with the hope of improving the diagnosis and treatment of such psychiatric conditions as major depression.
Detailed description
From the blood sample you donate, the researchers will obtain DNA. This DNA will be used to search for DNA markers related to the underlying biology of psychiatric illness and how this might explain the symptoms of these disorders. Research using DNA is an important way to try to understand human disease and/or the role genes play in disease. In effect, part of your blood sample will be used to attempt to understand how genetic factors contribute to the symptoms of such psychiatric conditions as major depression.
Study design
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- You are currently experiencing symptoms that are consistent with an episode of major depression without symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or
- You are currently experiencing symptoms that are consistent with an episode of major depression with symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or
- You have been diagnosed with either schizophrenia or schizoaffective disorder, or
- You are a volunteer without a history of psychiatric illness (a healthy control subject).
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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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. This study is not recruiting at the moment.
Alan F Schatzberg, MD principal investigator
Stanford 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 Psychotic Disorders and Depressive Disorder, run by Stanford 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 19 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Jun 2019.