A Health Intervention to Prevent Depression Hepatitis C Patients

Major Depressive Disorder Clinical Trial

Official title:

An Exercise Intervention to Prevent Interferon-Induced Depression in Hepatitis C

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01890083
• Other study ID #: K01MH097847
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 5, 2013
• Last updated: December 28, 2016
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: December 2016
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed with Hepatitis C and prescribed IFN-a

• 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.

Exclusion Criteria:

• 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.

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Hepatitis
• Hepatitis A
• Hepatitis C
• Major Depressive Disorder

Intervention

Behavioral:
• Exercise

• Health Education

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depressive Symptoms over 6 months		Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27	Yes
Secondary	Change in Sleep Quality over 6 months		Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27	No
Secondary	Change in blood biomarkers over 6 months		Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27	No