Genetic and Biochemical Markers of Interferon-Induced Depression.
NCT ID: NCT00252538
Last Updated: 2014-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
133 participants
OBSERVATIONAL
2006-04-30
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Research plan: We plan to test our hypothesis and accomplish the objectives of this application by pursuing the following two specific objectives:
1. to evaluate the role of genetic loci that may contribute to the vulnerability to IFN using association analyses. Vulnerability is operationalized as the maximal Beck Depression Inventory-II (BDI-II) score, co-varying for pre-treatment BDI-II scores, and
2. to identify the effects and time course of antiviral therapy on potential biomarkers of IFN-induced depression, including tryptophan, 5-HT, and cortisol levels. Changes in biochemical levels will be compared to depressive symptomology and genetic vulnerability.
3. Methodology: Patients will be asked to participate in a prospective study in which they will be monitored during the course of IFN therapy for symptoms of depression and for biochemical changes measured in their blood. 120 HCV patients initiating IFN therapy will be recruited (3/month for 40 months) from the Portland VA and the Long Beach VA Medical Centers. Following baseline assessments, subjects will be followed every 2 weeks for a period of 4 months. The development of major depression, depressive symptoms, and related IFN-induced side effects will be monitored using rating scales. For genetic and biochemical measures, blood samples will be collected prior to and during IFN therapy. Patients will be tested for certain genetic polymorphisms.
Analyses. Using linear regression, genotype will be the independent variable, and co-varying for baseline BDI-II score, the maximal BDI-II score will be examined as a dependent variable. An ANOVA for repeated measures will be performed to determine the effects of IFN therapy on tryptophan, 5-HT, and cortisol levels. In addition, the relationship between interferon induced MDD and certain polymorphisms will be examined.
4. Findings, results or conclusions reached to date: In preliminary studies we found that 33% of HCV patients on IFN therapy developed major depressive disorder during the course of treatment. In addition, preliminary pilot results suggest that the 5-HT transporter polymorphism short allele and the "C" allele for the tryptophan hydroxylase polymorphism may increase vulnerability to IFN-induced depression.
5. Clinical relevance: There are currently no known, reliable predictors of IFN-induced depression. The chronic disease of HCV infection collectively affects approximately 4 million Americans and 200 million people worldwide. IFN is the only clinically approved medication whose long-term use can reduce the risk of a fatal outcome and even be curative in some individuals. However, side effects associated with IFN therapy represent a major obstacle to adequate treatment for patients with HCV, often resulting in the discontinuation IFN therapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18 or older
3. Not pregnant and using adequate contraception
4. Hepatologist-determined patient is a candidate for interferon therapy
5. Written/signed informed consent specific for this protocol has been obtained prior to entry
Exclusion Criteria
2. On antidepressant medications for any reason
3. Currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Hauser, MD
Role: PRINCIPAL_INVESTIGATOR
VA Medical Center, Long Beach
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Medical Center, Long Beach
Long Beach, California, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States
VA Medical Center, Portland
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Loftis JM, Patterson AL, Wilhelm CJ, McNett H, Morasco BJ, Huckans M, Morgan T, Saperstein S, Asghar A, Hauser P. Vulnerability to somatic symptoms of depression during interferon-alpha therapy for hepatitis C: a 16-week prospective study. J Psychosom Res. 2013 Jan;74(1):57-63. doi: 10.1016/j.jpsychores.2012.10.012. Epub 2012 Nov 21.
Lotrich FE, Loftis JM, Ferrell RE, Rabinovitz M, Hauser P. IL28B polymorphism is associated with both side effects and clearance of hepatitis C during interferon-alpha therapy. J Interferon Cytokine Res. 2011 Mar;31(3):331-6. doi: 10.1089/jir.2010.0074. Epub 2010 Dec 6.
Related Links
Access external resources that provide additional context or updates about the study.
The Veterans Affairs National Hepatitis C Web site provides information about viral hepatitis for health care providers inside and outside the VA system, Veterans, and the General Public.
This is the Center for Disease Control's (CDC) website that provides information about Hepatitis C.
The official website for the American Liver Foundation, which provides educational information and other resources for people with hepatitis C.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MHBA-020-04F
Identifier Type: -
Identifier Source: org_study_id