Hepatitis CPhase 2/3NCT01890083
A Health Intervention to Prevent Depression Hepatitis C Patients
A Phase 2/3 study testing Exercise and Health Education in people with Hepatitis C and Major Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Interferon-alpha (IFN-α) is an efficacious treatment for Hepatitis C (HPC); however, IFN-α treatment results in a significant increase in depressive symptoms. The aim of this project is to compare two health interventions (exercise vs. health education) to prevent depression in HPC patients receiving IFN-α. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Major Depressive Disorder
- What is being tested?
- Exercise and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2015
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Hepatitis C and prescribed IFN-α
- Ability to understand and willingness to provide written informed consent.
- Willing to provide contact information.
- Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures.
- Able to comprehend and communicate in English.
Who cannot join
- Have a medical condition contraindicating exercise participation
- Are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
- Have been diagnosed with current Major Depressive Disorder or are currently receiving antidepressant medication treatment (including SSRIs and SNRIs)
- Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee.
- Pregnancy.
- Current psychotic disorder. Other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
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- Anticipated circumstances over the 6-month course of the trial that would render the participant unlikely to complete the study in the judgment of the PI or designee.
- Any reason not listed herein yet, determined by the PI, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the PI, medical personnel, or designee make participation in the study hazardous.
- Are currently enrolled in another research study, and participation in that study contraindicates participation in the current study
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-9119
About this study
Official title: An Exercise Intervention to Prevent Interferon-Induced Depression in Hepatitis C
Interferon-alpha (IFN-α) is an efficacious treatment for Hepatitis C (HPC); however, IFN-α treatment results in a significant increase in depressive symptoms. The aim of this project is to compare two health interventions (exercise vs. health education) to prevent depression in HPC patients receiving IFN-α. Participants will be recruited from the Clinical Center for Liver Diseases at UT-Southwestern and randomized to 26 weeks of either: aerobic exercise or a health education control group.
- Conditions
- Hepatitis C, Major Depressive Disorder
- Being tested
- Exercise, Health Education
- Keywords
- Hepatitis C, Interferon-alpha, Depression, Major Depressive Disorder, Exercise, Physical Activity
- Medical subject headings
- Hepatitis C, Depressive Disorder, Major, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Health EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Health Education | Active comparator | Participants will three attend heath education sessions per week for 26 weeks. Receives: Behavioral: Health Education |
| Exercise | Experimental | Participants will engage in a public health dose of moderate-to-vigorous aerobic exercise for 26 weeks. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms over 6 months
Measured: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
Secondary outcomes (2)
Change in Sleep Quality over 6 months
Measured: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
Change in blood biomarkers over 6 months
Measured: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Lack of eligible patients due to introduction of new drugs for Hepatitis C
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.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad D Rethorst, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890083
- Sponsor's protocol ID
- K01MH097847
- Status last verified
- Dec 2016
- First submitted
- 5 Jun 2013
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exercise Intervention to Prevent Interferon-Induced Depression in Hepatitis C
- ClinicalTrials.gov ID
- NCT01890083
- Acronym / sponsor ID
- K01MH097847
- Conditions
- Hepatitis C, Major Depressive Disorder
- Keywords
- Hepatitis C, Interferon-alpha, Depression, Major Depressive Disorder, Exercise, Physical Activity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible patients due to introduction of new drugs for Hepatitis C
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Jul 2013 (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.
Interferon-alpha (IFN-α) is an efficacious treatment for Hepatitis C (HPC); however, IFN-α treatment results in a significant increase in depressive symptoms. The aim of this project is to compare two health interventions (exercise vs. health education) to prevent depression in HPC patients receiving IFN-α. Participants will be recruited from the Clinical Center for Liver Diseases at UT-Southwestern and randomized to 26 weeks of either: aerobic exercise or a health education control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education | Active comparator | Behavioral: Health EducationParticipants will three attend heath education sessions per week for 26 weeks. |
| Exercise | Experimental | Behavioral: ExerciseParticipants will engage in a public health dose of moderate-to-vigorous aerobic exercise for 26 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Hepatitis C and prescribed IFN-α
- Ability to understand and willingness to provide written informed consent.
- Willing to provide contact information.
- Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures.
- Able to comprehend and communicate in English.
Key exclusion criteria (9 listed)
- Have a medical condition contraindicating exercise participation
- Are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
- Have been diagnosed with current Major Depressive Disorder or are currently receiving antidepressant medication treatment (including SSRIs and SNRIs)
- Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee.
- Pregnancy.
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 |
|---|---|---|
| Exercise | Behavioural | Exercise |
| Health Education | Behavioural | Health Education |
Primary outcome
Change in Depressive Symptoms over 6 months
Time frame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
2 secondary outcomes
Change in Sleep Quality over 6 months
Time frame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
Change in blood biomarkers over 6 months
Time frame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27
Results and safety
The study was stopped early (reason given: Lack of eligible patients due to introduction of new drugs for Hepatitis C). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Chad D Rethorst, Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exercise and Health Education in people with Hepatitis C and Major Depressive Disorder, run by University of Texas Southwestern Medical Center 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 9 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: stopped early, as of the sponsor's last update on 29 Dec 2016. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Lack of eligible patients due to introduction of new drugs for Hepatitis C). Results are not available in the source record.
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.
What does the primary outcome measure?
Change in Depressive Symptoms over 6 months (time frame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27). It is what the study was designed to measure, not a finding.
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 29 Dec 2016.