Depression, HIV Infections
Conditions
Keywords
HIV infection, Depression, Men who have sex with men, Drug abuse
Brief summary
The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their depression than when treated with placebo. High-risk behaviors include using illegal drugs and participating in unprotected sexual intercourse. The specific pharmacotherapy used in this study was the anti-depressant, bupropion. The subject population consisted of HIV negative men who have sex with men (MSM) with mild-to-moderate depression.
Detailed description
Depression in men is often masked by high-risk behaviors such as alcohol and drug abuse. Common symptoms among depressed men include feelings of hopelessness and helplessness, irritability, and anger. MSM are among those at highest for HIV acquisition due to high-risk behaviors, including unprotected sexual intercourse and drug abuse. Bupropion is an antidepressant medication commonly used to treat depression. The purpose of this study thus was whether bupropion could help MSM with mild-to-moderate depression reduce their high-risk behaviors. Participants in this trial were randomly assigned to receive either bupropion or placebo for 6 months. Study visits lasting approximately 2 hours each occurred at Day 0, and at Months 4, 6, and 9; included in these visits were physical examination, testing for HIV and sexually transmitted disease (STD), depression screening, and an interview-administered questionnaire inquiring into sexual activity and drug use. Shorter study visits, lasting 15 - 30 minutes each occurred at Day 15, and Months 1, 2, 4, 5, and 7, and included depression screening and physical exam.
Interventions
DRUGBupropion
Participants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
DRUGPlacebo
Participants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
Sponsors
National Institute on Drug Abuse (NIDA)
GlaxoSmithKline
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Available for at least 9 months, or the duration of the study * Willing to complete HIV testing and counseling * History of HIV testing and counseling * At high risk of HIV infection, indicated by more than one male sexual partner in the 3 months prior to study entry * Meets criteria for either (a) major depression or dysthymia within a mild-to-moderate level according to standard criteria DSM-IV, or (b) minor depression as defined by one or more of the following symptoms at any time and for any duration during the past 12 months: significant weight loss or gain, or significant decrease or increase in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of energy; inappropriate feelings of worthlessness or guilt; inability to concentrate; indecisiveness; and recurrent thoughts of death or suicide.
Exclusion criteria
* HIV infected * Sexual intercourse in the 3 months prior to study entry with only one partner, and in a monogamous relationship * Currently enrolled in another study involving repeated HIV testing and counseling * Receiving treatment for depression with antidepressant medication for any length of time within the year prior to study entry * Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any reason * Severe depression or at suicidal risk * No evidence or prior history of depression * Homicidal or other similar problem that, in the opinion of the investigator, may endanger study staff and participants * Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed to enroll 14 days after discontinuing use of a MAOI. * History of seizures * History or current symptoms of bipolar disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment. | Enrollment to Month 6 | The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire. | Month 6 compared to Month 0 (enrollment) | Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit. |
| Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing) | Enrollment to Month 6 | Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview. |
| Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6. | Month 6 compared to enrollment (Month 0) | The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment |
Countries
United States
Participant flow
Recruitment details
Recruitment: Sept. 2002 - March 2004. High-risk, HIV-seronegative, New York City men who have sex with men (MSM) were informed of the study by field workers at MSM-oriented bars, clubs and community events; advertisements in magazines distributed at such venues; and e-mails to persons offering sexual services for MSM on the Internet.
Participants by arm
| Arm | Count |
|---|---|
| Bupropion Participants in this arm received bupropion. | 20 |
| Placebo Participants in this arm received placebo. | 21 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Month 3 | Lost to Follow-up | 3 | 3 |
| Month 3 | Withdrawal by Subject | 1 | 0 |
| Month 6 | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Bupropion | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 32.5 years | 32 years | 32 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 34 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 26 Participants | 16 Participants |
| Region of Enrollment United States | 20 participants | 41 participants | 21 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 41 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 20 | 18 / 21 |
| serious Total, serious adverse events | 1 / 20 | 0 / 21 |
Outcome results
Primary
The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.
Time frame: Enrollment to Month 6
Population: Subjects remaining in study through 6-Month study visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupropion | The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment. | -2.5 Sexual partners |
| Placebo | The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment. | -4 Sexual partners |
p-value: 0.9Wilcoxon (Mann-Whitney)
Secondary
Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment
Time frame: Month 6 compared to enrollment (Month 0)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupropion | Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6. | -11.5 units on a scale |
| Placebo | Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6. | -9 units on a scale |
p-value: 0.19Wilcoxon (Mann-Whitney)
Secondary
Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.
Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.
Time frame: Month 6 compared to Month 0 (enrollment)
Population: All subjects who were randomized, met study inclusion/exclusion criteria and were followed through Month 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupropion | Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire. | 0.5 Drug-using occasions per month |
| Placebo | Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire. | 0 Drug-using occasions per month |
Comparison: Wilcoxon rank testp-value: 0.3Wilcoxon (Mann-Whitney)
Secondary
Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)
Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.
Time frame: Enrollment to Month 6
Population: Self-reported and laboratory identified sexually transmitted infections
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupropion | Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing) | 3 participants |
| Placebo | Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing) | 1 participants |
Comparison: Comparison of cumulative incidence proportionsp-value: 0.395% CI: [0.4, 27.8]Fisher Exact