Hepatitis CPhase 4NCT00108563
VISN 20: Prophylactic Treatment of Interferon-Induced Depression in Hepatitis C Patients
A Phase 4 study of Hepatitis C and Depression, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to learn more about the effects of interferon and ribavirin combination therapy in people with Hepatitis C. The specific aims are: To assess how often depressive symptoms occur in patients taking combination alpha interferon plus ribavirin or pegylated interferon plus ribavirin therapy for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Depression
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Sep 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female, age 18 or older
- Planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic HCV (hepatitis C virus)
Who cannot join
- Chronic liver disease other than chronic HCV
- Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
- A history of organ transplantation
- Any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: *active seizure disorders requiring medication; *history of major CNS (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc)
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection).
- Inability to read and write at a level sufficient to complete self-report forms
Show all 13Show fewer
- History of significant non-compliance with medical treatments and appointments
- Patients currently, or within the last three months, on a full therapeutic dose of antidepressant medication, or a dose of other medication such that it may significantly affect depressive symptomatology
- Patients with active depression in the previous 3 months and/or those with BDI (Beck Depression Inventory)-II greater than or equal to 15 at the time of study entry.
- Patients with bipolar disorder or history of bipolar disorder
- Patients with active psychotic symptoms or diagnosis of schizophrenia in the previous 3 months
- Active substance abuse, such as alcohol (greater than 80 gm/day), IV (intravenous) drugs, and inhaled drugs. If the patient has a history of substance abuse, in order to be considered for inclusion into the protocol, the patient must have been in a sustained remission for at least 6 months
- Patients receiving opiate agonist therapy (e.g., methadone maintenance therapy) within the past year, unless a program of testing for continued substance abuse is initiated (testing at entry and then randomly at least every 2-3 months) and the patient is withdrawn from study for any violation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VISN 20 Prophylactic Treatment of IFN-Induced Depression in Hepatitis C
The purpose of this study is to learn more about the effects of interferon and ribavirin combination therapy in people with Hepatitis C. The specific aims are:
- To assess how often depressive symptoms occur in patients taking combination alpha interferon plus ribavirin or pegylated interferon plus ribavirin therapy for Hepatitis C, when depressive symptoms occur, and how severe the depressive symptoms are when they do occur;
- To identify potential predictors for the development of depressive symptoms;
- To identify if citalopram, an antidepressant medication, can prevent or lessen the severity of depressive symptoms brought about by interferon therapy.
- Conditions
- Hepatitis C, Depression
- Being tested
- Citalopram or Placebo
- Keywords
- Hepatitis C, Depression, Interferon-alpha, Citalopram, ribavirin, antidepressive agents
- Medical subject headings
- Hepatitis C, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram or PlaceboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2005 (estimated)
- Study startOct 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108563
- Sponsor's protocol ID
- CLIN-012-02S
- Status last verified
- May 2007
- First submitted
- 15 Apr 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISN 20 Prophylactic Treatment of IFN-Induced Depression in Hepatitis C
- ClinicalTrials.gov ID
- NCT00108563
- Acronym / sponsor ID
- CLIN-012-02S
- Conditions
- Hepatitis C, Depression
- Keywords
- Hepatitis C, Depression, Interferon-alpha, Citalopram, ribavirin, antidepressive agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2003
- Study completion
- Sep 2006
- First posted
- 18 Apr 2005 (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 study is to learn more about the effects of interferon and ribavirin combination therapy in people with Hepatitis C. The specific aims are:
- To assess how often depressive symptoms occur in patients taking combination alpha interferon plus ribavirin or pegylated interferon plus ribavirin therapy for Hepatitis C, when depressive symptoms occur, and how severe the depressive symptoms are when they do occur;
- To identify potential predictors for the development of depressive symptoms;
- To identify if citalopram, an antidepressant medication, can prevent or lessen the severity of depressive symptoms brought about by interferon therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male or female, age 18 or older
- Planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic HCV (hepatitis C virus)
Key exclusion criteria (13 listed)
- Chronic liver disease other than chronic HCV
- Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
- A history of organ transplantation
- Any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: *active seizure disorders requiring medication; *history of major CNS (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc)
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection).
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 |
|---|---|---|
| Citalopram or Placebo | Drug | – |
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 21 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Hepatitis C and Depression, run by US Department of Veterans Affairs 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 2 inclusion and 13 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 21 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 21 Jan 2009.