Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Antidepressant Medication Plus Directly Observed Therapy for Improving Adherence to Antiretroviral Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Bangsberg, MD, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00338767
First received: June 16, 2006
Last updated: November 13, 2013
Last verified: November 2013

June 16, 2006
November 13, 2013
January 2001
August 2006   (final data collection date for primary outcome measure)
Improved depression scores [ Time Frame: Measured at the end of 9 months ] [ Designated as safety issue: No ]
Improved depression scores (measured at Month 9)
Complete list of historical versions of study NCT00338767 on ClinicalTrials.gov Archive Site
  • HIV viral load [ Time Frame: Measured monthly for 9 months ] [ Designated as safety issue: No ]
  • CD4 Count [ Time Frame: Measured at baseline and Months 3, 6, and 9 ] [ Designated as safety issue: No ]
CD4 and viral load (measured at Month 9)
Not Provided
Not Provided
 
Antidepressant Medication Plus Directly Observed Therapy for Improving Adherence to Antiretroviral Therapy
Depression Treatment to Improve Antiretroviral Adherence

This study will evaluate the effectiveness of directly observed therapy plus antidepressant medication in improving adherence to antiretroviral drug therapy among HIV-infected homeless and marginally housed people with depression.

Antiretroviral drug therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A 95% adherence rate to ART is required to adequately suppress the virus and prevent transmission. Low ART adherence rates are often linked to depression, which is especially common in HIV-infected homeless or marginally housed people. In these cases, treatment with antidepressant medication may be useful in improving ART adherence. Directly Observed Therapy (DOT), in which medication intake is closely monitored, is another method of enhancing treatment compliance. DOT improved treatment adherence during the tuberculosis epidemic of the 1990s, and is now gaining recognition as a model for improving ART adherence. This study will evaluate the effectiveness of combining DOT and antidepressant medication in improving ART adherence among HIV-infected homeless and marginally housed people with depression.

Participants in this 9-month, open-label study will be randomly assigned to a treatment group or a control group. The control group will be given the phone number of the University of California, San Francisco AIDS Health Project (AHP) to call and make an appointment with a psychiatrist. Participants who attend appointments will be evaluated to determine their mental health status. Participants who are deemed to benefit from treatment will be scheduled for regular appointments at the AHP, but will be responsible for administering their own medications. The treatment group will meet with a study psychiatrist, who will prescribe an appropriate antidepressant medication. Subsequent meetings with the psychiatrist will occur weekly for the first 3 weeks, and then monthly for the duration of the study. Additionally, participants will have DOT visits every weekday morning for 1 month to take their antidepressant medications. After the first month, DOT visits will occur weekly or biweekly, depending on the medication regimen. If an individual does not attend a visit, study staff will try to locate the individual in the neighborhood to deliver the medication. Medication for the weekend will be prepared by study staff, but participants will take it on their own at home. For the last 2 months of the study, DOT visits will occur once monthly, at which time participants will receive their entire month's supply of medication.

Participants in both groups will be asked to report to the study site weekly for 6 months and then monthly for the final 3 months to provide an update on the status of their housing, healthcare providers, case managers, and HIV medications. Additional interviews about housing, income, use of health services, drug use, sexual practices, and mental health will occur at the beginning of the study and three more times throughout the study. Blood tests will be performed monthly to assess viral load, and every 3 months to assess CD4 count. Participants taking HIV medications will be visited by study staff at home once a month so that use of HIV medications can be determined. At the end of the study, participants in the control group may continue receiving treatment at the AHP. Six months after the end of the study, participants in the treatment group may also begin treatment with a psychiatrist at the AHP.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Depression
  • Behavioral: Directly Observed Therapy (DOT)
    DOT includes storefront directly observed therapy of prescribed anti-depressants. Participants will meet with a study psychiatrist, who will prescribe an appropriate antidepressant medication. Subsequent meetings with the psychiatrist will occur weekly for the first 3 weeks, and then monthly for the duration of the study. Additionally, participants will have DOT visits every weekday morning for 1 month to take their antidepressant medications. After the first month, DOT visits will occur weekly or biweekly, depending on the medication regimen.
  • Drug: Fluoxetine
    Medication treatment includes flouxetine for treatment of depression.
  • Experimental: Treatment
    Participants receiving storefront directly observed therapy of anti-depressants (Fluoxetine)
    Interventions:
    • Behavioral: Directly Observed Therapy (DOT)
    • Drug: Fluoxetine
  • No Intervention: Control
    Participants receiving referral to mental health follow-up with the UCSF AIDS Health Project
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2006
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Homeless or marginally housed
  • Score of greater than 13 on the Beck Depression Inventory (BDI)
  • DSM-IV diagnosis of major depressive disorder, dysthymia, or minor depressive disorder
  • Considered by the reviewing psychiatrist to benefit from antidepressant therapy
  • Willing to take antidepressant medication or, if currently taking medication, willing to change medications if deemed appropriate
  • Consents to coordinate with the primary medical provider
  • Speaks English

Exclusion Criteria:

  • Signs and symptoms consistent with diagnosis of dementia, as defined by DSM-IV
  • Current substance abuse disorder requiring immediate residential or inpatient treatment
  • At risk for suicide
  • Presence of signs and symptoms consistent with psychotic depression, as defined by DSM-IV, warranting immediate hospitalization
  • Any condition or use of any medication that may make simultaneous use of antidepressant medication unsafe
  • Currently prescribed antidepressant therapy and in psychiatric treatment (treated by a psychiatrist within 3 months prior to study entry)
  • Pregnant
  • Bipolar disorder
  • Current psychotic disorder
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338767
R01 MH63011, R01MH063011
No
David Bangsberg, MD, National Institute of Mental Health (NIMH)
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: David R. Bangsberg, MD, MPH University of California, San Francisco
Massachusetts General Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP