Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users
Maintaining HIV Risk Reduction Among Needle Exchangers
2 other identifiers
interventional
265
1 country
1
Brief Summary
This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 depression
Started Sep 2000
Typical duration for phase_3 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 26, 2005
CompletedFirst Posted
Study publicly available on registry
September 28, 2005
CompletedAugust 22, 2013
August 1, 2013
September 26, 2005
August 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maintenance of HIV risk-free drug behavior (measured at Month 12)
Secondary Outcomes (1)
Reduction in depressive symptoms (measured at Month 12)
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV diagnosis of major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia
- Score of greater than 14 on the Hamilton Rating Scale for Depression
- Current opiate or cocaine use
- History of injection equipment sharing
- English-speaking
You may not qualify if:
- History of injection equipment sharing within 6 months of study entry
- Currently at risk for suicide
- Currently experiencing symptoms of psychosis
- Currently taking any other psychotropic medication
- Diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or paranoid disorder
- Informed that treatment with antidepressant medications is medically inadvisable
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Related Publications (1)
Hayaki J, Stein MD, Lassor JA, Herman DS, Anderson BJ. Adversity among drug users: relationship to impulsivity. Drug Alcohol Depend. 2005 Apr 4;78(1):65-71. doi: 10.1016/j.drugalcdep.2004.09.002.
PMID: 15769559BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Stein, MD
Rhode Island Hospital
- STUDY DIRECTOR
Penelope Dennehy, MD
Rhode Island Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 26, 2005
First Posted
September 28, 2005
Study Start
September 1, 2000
Study Completion
September 1, 2004
Last Updated
August 22, 2013
Record last verified: 2013-08