SchizophreniaNCT00573300
Disturbances of Kynurenine Pathway of Trytophan Metabolism in Schizophrenia: A Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) Study
An observational study of Schizophrenia, run by North Suffolk Mental Health Association at 1 site in United States.
Trial summary
In this pilot study, the investigators propose to characterize the pattern of activation of the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Schizophrenia patients
Who may be able to join
- Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
- Ages 18-65 years
- Males or females
- English speaking with ability to complete symptom ratings
- Ability to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disturbances of Kynurenine Pathway of Trytophan Metabolism in Schizophrenia: A Quantitative RT-PCR Study
In this pilot study, the investigators propose to characterize the pattern of activation of the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. To do this, the investigators will measure the gene expression of several major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization of the activation of this metabolic pathway.
Read the detailed description
In this pilot study, we propose to characterize the pattern of activation of the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. To do this, we will measure the gene expression of several major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization of the activation of this metabolic pathway.
Primary hypotheses: We hypothesize that patients with schizophrenia will differ in their expression of macrophage IDO mRNA, reflecting activation of this pathway compared to normals. We further hypothesize that patients with deficit syndrome will have higher degrees of enzyme activation.
Secondary hypotheses: Serum tryptophan levels will be lower in patients with schizophrenia compared to controls, and they will correlate with measures of dysphoria. Serum kynurenine levels will be elevated in patients with schizophrenia, particularly in deficit syndrome patients. mRNA expression levels of enzymes downstream from IDO will differ between patients and controls. Measures of immune activation will be influenced by medical disease burden (medical comorbidities).
- Conditions
- Schizophrenia
- Being tested
- Phlebotomy
- Keywords
- Schizophrenia, Immune System, Kynurenate, tryptophan metabolism, NMDA receptor, indolamine 2,3-deoxygenase (IDO)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyProcedure or surgery
Single blood draw
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Schizophrenia Patients Receives: Procedure: Phlebotomy | |
| Healthy Controls | Healthy Controls Receives: Procedure: Phlebotomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Suffolk Mental Health Association
- Sponsor type
- University, hospital or other
- Investigators
- Oliver Freudenreich, M.D., Principal investigator, North Suffolk Mental Health Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573300
- Sponsor's protocol ID
- CORRC#10-2005
- Status last verified
- Aug 2009
- First submitted
- 13 Dec 2007
- Last updated
- 12 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disturbances of Kynurenine Pathway of Trytophan Metabolism in Schizophrenia: A Quantitative RT-PCR Study
- ClinicalTrials.gov ID
- NCT00573300
- Acronym / sponsor ID
- CORRC#10-2005
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Immune System, Kynurenate, tryptophan metabolism, NMDA receptor, indolamine 2,3-deoxygenase (IDO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- North Suffolk Mental Health AssociationUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 Dec 2007 (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.
In this pilot study, the investigators propose to characterize the pattern of activation of the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. To do this, the investigators will measure the gene expression of several major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization of the activation of this metabolic pathway.
Detailed description
In this pilot study, we propose to characterize the pattern of activation of the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. To do this, we will measure the gene expression of several major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization of the activation of this metabolic pathway.
Primary hypotheses: We hypothesize that patients with schizophrenia will differ in their expression of macrophage IDO mRNA, reflecting activation of this pathway compared to normals. We further hypothesize that patients with deficit syndrome will have higher degrees of enzyme activation.
Secondary hypotheses: Serum tryptophan levels will be lower in patients with schizophrenia compared to controls, and they will correlate with measures of dysphoria. Serum kynurenine levels will be elevated in patients with schizophrenia, particularly in deficit syndrome patients. mRNA expression levels of enzymes downstream from IDO will differ between patients and controls. Measures of immune activation will be influenced by medical disease burden (medical comorbidities).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | Procedure: PhlebotomySchizophrenia Patients |
| Healthy Controls | – | Procedure: PhlebotomyHealthy Controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Schizophrenia patients
Key inclusion criteria (5 listed)
- Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
- Ages 18-65 years
- Males or females
- English speaking with ability to complete symptom ratings
- Ability to provide informed consent
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhlebotomySingle blood draw | Procedure or surgery | Healthy Controls, Schizophrenia |
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 12 Aug 2009.
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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.
Oliver Freudenreich, M.D. principal investigator
North Suffolk Mental Health Association
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 Schizophrenia, run by North Suffolk Mental Health Association 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 5 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 12 Aug 2009. 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 12 Aug 2009.