DepressionPhase 3NCT00228007
Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users
A Phase 3 study testing Antidepressant Medication in people with Depression and Substance-Related Disorders, run by Butler Hospital at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression, Substance-Related Disorders, HIV Infections
- What is being tested?
- Antidepressant Medication
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Sep 2004
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Maintaining HIV Risk Reduction Among Needle Exchangers
This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression.
Read the detailed description
Depression and injection drug use often come hand-in-hand. This is especially true in populations with limited access to mental health care and with a high risk of illness and HIV transmission. Depressed injection drug users in these populations usually continue their drug use for extended periods of time, thereby further promoting the spread of HIV. This cycle has created a significant public health problem. It is necessary to explore new approaches to facilitate and maintain long-term behavior changes within this population. This study will evaluate the effectiveness of treatment with antidepressant medications in reducing HIV risk behaviors in depressed intravenous drug users.
Participants in this open label study will be randomly assigned to receive either antidepressant treatment or no treatment. Participants in the treatment group will meet with a psychiatrist monthly for 12 months. Based on psychiatric evaluations and participants' medical histories, doctors will prescribe an appropriate antidepressant medication or a combination of medications. Participants in the treatment group may also receive referrals for other services if necessary. Participants assigned to receive no treatment will be contacted at Months 3 and 9 to verify their contact information; they will also receive any necessary referrals. All participants will partake in interviews at baseline and Months 6 and 12 to assess changes in HIV risk behavior and depressive symptoms.
- Conditions
- Depression, Substance-Related Disorders, HIV Infections
- Being tested
- Antidepressant Medication
- Keywords
- Injection Drug Use, HIV Risk Behavior, HIV Seronegativity
- Medical subject headings
- Depression, Substance-Related Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antidepressant MedicationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of HIV risk-free drug behavior (measured at Month 12)
Secondary outcomes (1)
Reduction in depressive symptoms (measured at Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startSep 2000
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Michael Stein, MD, Principal investigator, Rhode Island HospitalPenelope Dennehy, MD, Study director, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228007
- Sponsor's protocol ID
- R01MH062719
- Other IDs
- R01MH062719, DAHBR AZ-Q
- Status last verified
- Aug 2013
- First submitted
- 26 Sep 2005
- Last updated
- 22 Aug 2013
- Results posted
- No
Publications
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.
PubMed 15769559
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining HIV Risk Reduction Among Needle Exchangers
- ClinicalTrials.gov ID
- NCT00228007
- Acronym / sponsor ID
- R01MH062719
- Conditions
- Depression, Substance-Related Disorders, HIV Infections
- Keywords
- Injection Drug Use, HIV Risk Behavior, HIV Seronegativity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2000
- Study completion
- Sep 2004 (actual)
- First posted
- 28 Sep 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.
This study will evaluate the effectiveness of antidepressant medication treatment in reducing HIV risk behaviors in intravenous drug users with depression.
Detailed description
Depression and injection drug use often come hand-in-hand. This is especially true in populations with limited access to mental health care and with a high risk of illness and HIV transmission. Depressed injection drug users in these populations usually continue their drug use for extended periods of time, thereby further promoting the spread of HIV. This cycle has created a significant public health problem. It is necessary to explore new approaches to facilitate and maintain long-term behavior changes within this population. This study will evaluate the effectiveness of treatment with antidepressant medications in reducing HIV risk behaviors in depressed intravenous drug users.
Participants in this open label study will be randomly assigned to receive either antidepressant treatment or no treatment. Participants in the treatment group will meet with a psychiatrist monthly for 12 months. Based on psychiatric evaluations and participants' medical histories, doctors will prescribe an appropriate antidepressant medication or a combination of medications. Participants in the treatment group may also receive referrals for other services if necessary. Participants assigned to receive no treatment will be contacted at Months 3 and 9 to verify their contact information; they will also receive any necessary referrals. All participants will partake in interviews at baseline and Months 6 and 12 to assess changes in HIV risk behavior and depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Antidepressant Medication | Drug | – |
Primary outcome
Maintenance of HIV risk-free drug behavior (measured at Month 12)
1 secondary outcome
Reduction in depressive symptoms (measured at Month 12)
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 22 Aug 2013.
- Background: PubMed 15769559Hayaki 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.
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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.
Michael Stein, MD principal investigator
Rhode Island Hospital
Penelope Dennehy, MD study director
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antidepressant Medication in people with Depression and Substance-Related Disorders, run by Butler Hospital 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 7 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 22 Aug 2013. 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 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 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.
What does the primary outcome measure?
Maintenance of HIV risk-free drug behavior (measured at Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00228007, which also lists 1 linked publication.
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 22 Aug 2013.