Genetic and Biochemical Markers of Interferon-Induced Depression.

NCT00252538 | Completed Results

• 1 other identifier: MHBA-020-04F
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to identify predictors and associated biochemical markers of interferon-induced depression. It is hypothesized that genetic variation in genes related to the serotonergic system may predict vulnerability to interferon-induced depression.

Conditions

Depression

Keywords

Cortisol; Depression; Hepatitis C; Interferon; Polymorphism; Serotonin; Tryptophan

Outcome Measures

Primary Outcomes (1)

• Phenotype and Genotype Based on Presence of Interferon Induced MDD.

  Structured psychiatric interviews and symptom rating scales for depression were used as primary outcome measures to determine the association between phenotype (interferon-induced depression) and genotype (genes that confer risk of interferon-induced depression). Genes of interest related to development of depression and antiviral treatment response that may confer risk for interferon induced depression were examined. this was a multi-site study and included participants from several hospital settings. Three polymorphisms of the interleukin (IL)-28b gene were examined - the c/c, c/t and t/t - and the relationship to MDD was examined. P-values above 0.05 are considered statistically insignificant in this study. In a subsequent analysis of only VA participants proinflammatory cytokines and serotonin levels were examined relative to symptoms of depression.

  The proposed enrollment began after funding notification and enrollment will last for a period of 40 months and until end of study.

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

120 patients initiating interferon therapy will be recruited from the Portland, Minneapolis, and Long Beach VAMCs. The study is limited to only those participants who are currently mentally healthy at baseline and eligible to receive interferon therapy. 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

You may qualify if:

• Serum positive for hepatitis C
• Age 18 or older
• Not pregnant and using adequate contraception
• Hepatologist-determined patient is a candidate for interferon therapy
• Written/signed informed consent specific for this protocol has been obtained prior to entry

You may not qualify if:

• Diagnosis of active: depression, psychotic symptoms, or bipolar disorder (or history of bipolar disorder) during the previous 3 months
• On antidepressant medications for any reason
• Currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (3)

VA Medical Center, Long Beach

Long Beach, California, 90822, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

Related Publications (2)

• 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.

  PMID: 23272989 RESULT

• 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.

  PMID: 21133812 RESULT

Related Links

• 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are being collected to determine the variability in the development of depressive symptoms induced by interferon. Thus, we plan to measure specific genetic polymorphisms \[i.e., in the serotonin (5-HT) transporter gene-linked polymorphic region (5-HTTLPR), in the promoter of the 5-HT1A receptor subtype, and an intronic tryptophan hydroxylase polymorphism\]. Tryptophan, 5-HT, and cortisol blood levels will also be measured.

MeSH Terms

Conditions

Depression; Hepatitis C

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

Limitations include that there are numerous polymorphism in various genes that may influence certain symptoms of depression. The risk for side effects during interferon-alpha treatment likely influenced by many genetic polymorphisms.

Results Point of Contact

• Title: Peter Hauser
• Organization: VA Long Beach Healthcare System

peter.hauser2@va.gov

562 826 8000

Study Officials

• Peter Hauser, MD

  VA Medical Center, Long Beach

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: April 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 11, 2014
• Results First Posted: December 11, 2014

Record last verified: 2014-12

Locations

US (3)