Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.

BACKGROUND: Psilocybin is being studied for use in treatment-resistant depression. METHODS: In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits). RESULTS: A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P<0.001) and between the 10-mg group and 1-mg group was -2.5 (95% CI, -6.2 to 1.2; P = 0.18). In the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results. Adverse events occurred in 179 of 233 participants (77%) and included headache, nausea, and dizziness. Suicidal ideation or behavior or self-injury occurred in all dose groups. CONCLUSIONS: In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects. Larger and longer trials, including comparison with existing treatments, are required to determine the efficacy and safety of psilocybin for this disorder. (Funded by COMPASS Pathfinder; EudraCT number, 2017-003288-36; ClinicalTrials.gov number, NCT03775200.).

Individuals' experiences in genetic counseling and predictive testing for familial amyotrophic lateral sclerosis.

As clinical genetic testing in the amyotrophic lateral sclerosis (ALS) diagnostic setting increases, the identification of at-risk family members has also expanded. No practice guidelines specifically for predictive genetic testing exist, and few studies about the psychological impacts of testing in this subgroup have occurred, limiting the ability to tailor recommendations and counseling in this community. We surveyed asymptomatic individuals at risk for inheriting an ALS-associated gene mutation. The 80-question survey was designed using a combination of validated measures (General Anxiety Disorder; FACToR; Decision Regret Scale) and original items. Ninety participants completed the survey, including those who completed predictive genetic testing (N = 42) and those who did not (N = 48). Gene positive individuals experienced greater negativity, uncertainty, and overall psychological impairment (p = 0.002; p < 0.001; p = 0.001). Individuals who had not undergone testing reported thinking about their risk multiple times per day and experiencing more decisional regret than those who tested (p = 0.006). In terms of decision-making, being prepared for potential clinical drug trials was a more important potential benefit among those who underwent testing (p = 0.026). Participants valuing preparedness for clinical drug trials supports the concept that genetic testing for ALS will increase as research in gene-targeted therapeutics progresses. This study describes factors relevant to the genetic testing decision-making process and adaptation to results from the perspective of at-risk individuals, which can ultimately guide genetic counseling practice in this population.

Depressive Symptoms and Suicidal Ideation Among Symptomatic Patients With a History of Lyme Disease vs Two Comparison Groups.

BACKGROUND: Depression has been reported in 8-45% of patients with posttreatment Lyme symptoms (PTLS), but little is known about suicidal ideation in these patients. METHOD: Depression and suicidal ideation were assessed using the Beck Depression Inventory (BDI-II). Scores from the PTLS group (n = 81) were compared to those from 2 other groups: HIV+ patients being treated for fatigue (n = 70), and a nonpatient comparison group (NPCG; n = 44). ANOVA and t-tests were used to compare groups; logistic regression was used to identify the strongest correlates of suicidal ideation. RESULTS: Mean BDI-II scores fell in the mildly depressed range for PTLS and HIV+ patients, with both groups having higher depression scores than the NPCG. Suicidal ideation was reported by 19.8% of the PTLS patients and 27.1% of the HIV+ patients, a nonsignificant difference. Among those with mild or no depression, suicidal ideation was uncommon (6.5% PTLS and 11.9% HIV+). Among the patients with moderate-to-severe depression, suicidal ideation was more common (63.2% of 19 PTLS and 50% of 28 HIV+); among these, 2 with PTLS and 1 with HIV+ expressed suicidal intent. Further, 4.5% (n = 2) of the NPCG had suicidal ideation, each had scores in the moderate-to-severe depression range. Higher scores on the cognitive symptoms subscale of the BDI-II predicted greater likelihood of suicidal ideation across patient groups. CONCLUSION: As expected, suicidal ideation is increased among patients who are depressed. The fact that 1 in 5 patients with PTLS reported suicidal ideation highlights the importance of screening for depression and suicidality to optimize patient care.

A theory-informed, rapid cycle approach to identifying and adapting strategies to promote sustainability: optimizing depression treatment in primary care clinics seeking to sustain collaborative care (The Transform DepCare Study).

BACKGROUND: Few real-world examples exist of how best to select and adapt implementation strategies that promote sustainability. We used a collaborative care (CC) use case to describe a novel, theory-informed, stakeholder engaged process for operationalizing strategies for sustainability using a behavioral lens. METHODS: Informed by the Dynamic Sustainability Framework, we applied the Behaviour Change Wheel to our prior mixed methods to identify key sustainability behaviors and determinants of sustainability before specifying corresponding intervention functions, behavior change techniques, and implementation strategies that would be acceptable, equitable and promote key tenets of sustainability (i.e., continued improvement, education). Drawing on user-centered design principles, we enlisted 22 national and local stakeholders to operationalize and adapt (e.g., content, functionality, workflow) a multi-level, multi-component implementation strategy to maximally target behavioral and contextual determinants of sustainability. RESULTS: After reviewing the long-term impact of early implementation strategies (i.e., external technical support, quality monitoring, and reimbursement), we identified ongoing care manager CC delivery, provider treatment optimization, and patient enrollment as key sustainability behaviors. The most acceptable, equitable, and feasible intervention functions that would facilitate ongoing improvement included environmental restructuring, education, training, modeling, persuasion, and enablement. We determined that a waiting room delivered shared decision-making and psychoeducation patient tool (DepCare), the results of which are delivered to providers, as well as ongoing problem-solving meetings/local technical assistance with care managers would be the most acceptable and equitable multi-level strategy in diverse settings seeking to sustain CC programs. Key adaptations in response to dynamic contextual factors included expanding the DepCare tool to incorporate anxiety/suicide screening, triage support, multi-modal delivery, and patient activation (vs. shared decision making) (patient); pairing summary reports with decisional support and yearly onboarding/motivational educational videos (provider); incorporating behavioral health providers into problem-solving meetings and shifting from billing support to quality improvement and triage (system). CONCLUSION: We provide a roadmap for designing behavioral theory-informed, implementation strategies that promote sustainability and employing user-centered design principles to adapt strategies to changing mental health landscapes.

Randomized double-blind personalized N-of-1 clinical trial to test the safety and potential efficacy of TJ-68 for treating muscle cramps in amyotrophic lateral sclerosis (ALS): study protocol for a TJ-68 trial.

INTRODUCTION/AIMS: Muscle cramps are a common and often disabling symptom in amyotrophic lateral sclerosis (ALS), a devastating and incurable neurodegenerative disorder. To date, there are no medications specifically approved for the treatment of muscle cramps. Ameliorating muscle cramps in ALS may improve and sustain quality of life. A widely prescribed traditional Japanese (Kampo) medicine against muscle cramps, shakuyakukanzoto (TJ-68), has been studied in advanced liver disease, spinal stenosis, kidney failure, and diabetic neuropathy. The Japanese ALS Management Guideline mentions TJ-68 for difficult muscle cramps in ALS. Therefore, the rationale of our trial is to investigate the safety and effectiveness of TJ-68 in treating painful and disabling muscle cramps in people with ALS outside of Japan. Accordingly, we are conducting a randomized clinical trial to test the safety and efficacy of TJ-68 in participants with ALS reporting frequent muscle cramps using an innovative, personalized N-of-1 design. If successful, TJ-68 may be used for muscle cramps in a broader population of people with ALS. METHODS: This is a two-site, double-blind, randomized personalized N-of-1 early clinical trial with TJ-68. At least 22 participants with ALS and daily muscle cramps will receive drug or placebo for 2 weeks (one treatment period) followed by a 1-week washout in a four-period cross-over design. While the primary objective is to evaluate the safety of TJ-68, the study has 85% power to detect a one-point shift on the Visual Analog Scale for Muscle Cramps Affecting Overall Daily Activity of the Columbia Muscle Cramp Scale (MCS). Secondary outcomes include the full MCS score, a Cramp Diary, Clinical Global Impression of Changes, Goal Attainment Scale, quality of life scale and ALS functional rating scale-revised (ALSFRS-R). DISCUSSION: The study is underway. A personalized N-of-1 trial design is an efficient approach to testing medications that alleviate muscle cramps in rare disorders. If TJ-68 proves safe and efficacious then it may be used to treat cramps in ALS, and help to improve and sustain quality of life. TRIAL REGISTRATION: This clinical trial has been registered with ClinicalTrials.gov (NCT04998305), 8/9/2021.

DHEA and cognition in HIV-positive patients with non-major depression.

BACKGROUND: Dihydroepiandrosterone (DHEA) has been investigated for its potential role in improving cognition in a number of patient populations. Treatment options are limited for HIV-associated neurocognitive disorders. OBJECTIVE: The authors tested the effect of DHEA administration on the cognitive functioning of HIV-positive subjects with non-major depression. METHOD: The neuropsychological testing data for 60 HIV-positive patients enrolled in a clinical trial for non-major depression were analyzed to determine if DHEA-treated patients demonstrated improved cognitive functioning versus placebo. RESULTS: At baseline, 80% of the sample met criteria for asymptomatic cognitive impairment. No benefit in cognitive performance was found on 16 of 17 neuropsychological measures evaluated. One measure showed a modest benefit for placebo-treated patients over DHEA. CONCLUSION: DHEA treatment was not associated with improved cognitive performance in HIV-positive patients with non-major depression.

Case-control study in ALS using the National ALS Registry: lead and agricultural chemicals are potential risk factors.

Objective: To identify occupational risk factors for ALS using well-characterized participants with ALS (P-ALS), sibling controls (S-controls), and matched population controls (P-controls) within the National ALS Registry. We also compared oxidative stress (OS) biomarkers between groups. Methods: P-ALS were recruited over 4 years. Demographic, socioeconomic, and medical data were ascertained from medical records and structured interviews. P-ALS were followed prospectively for 2 years or until death, whichever came sooner. S-controls and age-, sex-, race/ethnicity-, and residential location-matched P-controls were recruited over 3 years. Occupational exposure to lead and agricultural chemicals (ACs) were assigned by an occupational hygienist, blinded to case status. OS biomarkers in urine were measured. Results: P-ALS (mean age 62.8 years; 63% males) resided across the United States. Demographic and socioeconomic variables did not differ among P-ALS, S-controls, and P-controls. P-ALS were more likely to report occupations with exposure to lead (adjusted OR (aOR)=2.3, 95% CI 1.1, 4.6) and ACs (aOR = 2.4, 95% CI 1.2, 4.6) compared to pooled controls. Among those with occupations with exposure to both lead and ACs, aOR was 7.2 (95% CI 2.0, 26.1). Urinary 8-oxo-dG was significantly elevated among P-ALS (11.07 ± 5.42 ng/mL) compared to S-controls, P-controls, or pooled controls (pooled 7.43 ± 5.42 ng/mL; p < 0.0001) but was not associated with occupational exposure to either lead or ACs. Conclusions: Findings reveal increased risk of ALS diagnosis among those with occupational exposure to lead and ACs and increased OS biomarkers among cases compared to controls. OS may be an important pathogenic mechanism in ALS.

Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial.

OBJECTIVE: To evaluate the efficacy and safety of armodafinil in the treatment of fatigue in HIV+ patients, and to assess its effect on depressive symptoms and behavior once fatigue remitted. METHOD: HIV+ patients with clinically significant fatigue were treated in a placebo-controlled randomized double-blind trial for 4 weeks. Armodafinil responders and placebo non-responders or relapsers were treated openly for a total of 16 weeks with armodafinil. The primary outcome measure for fatigue and depression was the Clinical Global Impressions-Improvement Scale, supplemented by the Fatigue Severity Scale, the Hamilton Depression Rating Scale, and the Beck Depression Inventory. Safety was assessed with assays of CD4 cell count and HIV RNA viral load and the SAFTEE side effects rating scale. Maximum trial dose of armodafinil was 250 mg/d. RESULTS: Seventy patients were enrolled. Attrition was 9%. In intention-to-treat analyses, fatigue response rate to armodafinil was 75% and to placebo, 26%. Armodafinil did not reduce depressive symptoms in the absence of improved energy, but of those patients with an Axis I depressive disorder at study entry whose energy improved, 82% experienced improved mood as well. Markers of immunologic suppression did not change during treatment. At 6 months, those still taking armodafinil had more energy and fewer depressive symptoms than those who were no longer taking it. CONCLUSIONS: As we found in our RCT of modafinil, armodafinil appears effective and well tolerated in treating fatigue in HIV+ patients. Side effects were minimal and most patients reported substantially improved energy and mood.

Comparison of counseling methods to promote employment for HIV+ ADULTS.

BACKGROUND: Despite improved health and during a strong job market (pre-COVID-19), a substantial proportion of HIV+ adults remained unemployed. This study sought to provide time-limited counseling to promote employment goals. OBJECTIVE: To determine whether behavioral activation (BA) or supportive counseling (SC), would be more effective in promoting vocational goals (full or part-time, paid or volunteer). METHODS: The study included two groups: those with clinically significant fatigue, who were first treated with armodafinil. Once their fatigue diminished, they were enrolled in the counseling program. Those without fatigue were enrolled directly. Both BA and SC interventions were manualized, consisting of eight individual sessions plus a follow-up. RESULTS: 116 participants entered counseling, including 87 assigned to BA and 29 to SC. Of these, 79 completed counseling or found a job by session eight. By follow-up, 51%of BA versus 41%of SC participants had found jobs, a non-significant difference either clinically or statistically. CONCLUSIONS: Multiple issues contributed to difficulty in employment, including gaps in resumes, loss of contact with former colleagues, and uncertainty about career direction. Ongoing barriers included substance use, housing instability, ambivalence about forfeiting government benefits, as well as inadequately treated depression. Success in employment for about half of participants is, in this context, a reasonable outcome.

A prospective cohort study of neuropsychological test performance in ALS.

Our objective was to determine the prevalence and predictors of cognitive impairment in ALS, measure differences in survival among impaired and unimpaired patients, and assess changes in neuropsychological test performance over time. Fifty patients were enrolled in a prospective cohort study of neuropsychological performance. ANOVA and chi(2) tests assessed differences in clinical characteristics and neuropsychologic test results; general estimating equations assessed change in test performance; multiple regression determined which variables contributed to cognitive status; and Cox models compared survival. Thirty-six patients were categorized as cognitively normal, and 14 were impaired. Impaired patients were older at testing (p = 0.024), but no more likely to have bulbar signs. Predicators of impairment were symptom duration (p < 0.001), motor function (p < 0.001), and rate of ALS progression (p < 0.001). The Benton recognition (p < 0.001), Boston naming (p = 0.001), Wisconsin Card Sort (p = 0.001) and word generation (p = 0.001) tests contributed most strongly to cognitive status. Survival was worse in impaired patients (p = 0.027). Over time, only animal word generation declined (p = 0.016). In conclusion, 28% percent of patients were cognitively impaired. Older age and more severe ALS were associated with impairment. The strongest neuropsychological predictors of cognitive status were measures of executive, episodic memory and language function. Cognitively impaired patients had shorter survival time.

Depression, distress and positive mood in late-stage cancer: a longitudinal study.

OBJECTIVES: To determine whether new-onset clinical depression emerges over time, and whether positive and negative mood levels change among patients with terminal cancer. METHODS: In this two-site study, 58 cancer patients seen at least twice were interviewed monthly until death or study termination. Major measures included the Patient Health Questionnaire-9, Holland System of Beliefs Inventory, and Positive and Negative Affect Schedule. RESULTS: At study entry, 7% of patients had major depressive disorder; another 9% had depressive symptoms but no Axis I diagnosis. Twenty-two percent were taking antidepressants. During visits ranging from 2 to 21 per patient, 76% of patients never had a depression diagnosis, 3% were always depressed, and 14% became depressed for the first time, almost exclusively at their final visit before death. Scores on positive mood were equivalent to or higher than scores on negative mood and did not change over time. Cancer site, hospice, spiritual beliefs, income, and caregiver mood were unrelated to depression. Spiritual beliefs were, however, associated with positive mood, hope, and better quality of life. CONCLUSIONS: In this exploratory study, terminally ill patients approaching death experienced positive as well as negative mood although a significant minority met criteria for major depression at the last visit before death. The findings suggest that major depression is not an inevitable part of the dying process in patients with terminal cancer. Further, the appropriateness of classifying sadness, loss of interest and thoughts that one would be better off dead in the last days of life as psychopathology should be reconsidered.

Provigil (modafinil) plus cognitive behavioral therapy for methamphetamine use in HIV+ gay men: a pilot study.

OBJECTIVES: To evaluate the efficacy of modafinil combined with cognitive behavioral therapy (CBT) for treatment of methamphetamine (MA) dependence among HIV+ gay men. METHODS: In a single blind trial, modafinil was administered for 12 weeks, followed by a 4-week placebo phase. CBT was conducted for 18 sessions over the 16-week study. Primary outcome measures were self-reported use of days per week plus urine toxicology assays. Additional measures included the Beck Depression Inventory, Cravings Scale, and O/C Crystal Use Scale. Response was defined as > 50% decline in days used per week. Thirteen patients were enrolled over an 18-month period. RESULTS: Ten patients (77%) completed the trial, although two discontinued modafinil due to side effects. Six of the ten study completers reduced their MA use by > 50%. CONCLUSIONS: These preliminary results suggest good retention using combined medication and psychotherapy, and support further examination of modafinil and CBT in double-blind placebo controlled trials.

Returning to work after fatigue treatment and counseling in HIV/AIDS.

BACKGROUND: Employment rates for people with HIV/AIDS are low, compared to the general population. One widespread barrier is fatigue, accompanied by daytime sleepiness and a lack of stamina. Previous pharmacological studies have demonstrated improvement of fatigue-related symptoms without affecting work-related goal attainmentOBJECTIVE:In this pilot study, we sought to determine whether a pharmacologic-behavioral two-phase combined approach could facilitate returning to work. METHODS: HIV+ participants with fatigue were treated with armodafinil. If energy improved, 8 sessions of biweekly manualized Behavioral Activation (BA) counseling were added to medication maintenance. Outcome was assessed on a 3-point scale along with clinician and self-ratings. RESULTS: Of the 46 participants enrolled in BA, 15 (33%) did not complete all 8 sessions: 6 got jobs so they no longer needed counseling; 4 did not like BA, and 5 dropped out for reasons such as moving away or substance use relapse. Of the 46, 29 (63%) attained their vocational goal and showed significant changes on self-report scales. CONCLUSIONS: Our integrated treatment including armodafinil plus BA counseling significantly increased the success of achieving work-related goals. The two-phase medication plus counseling program was well-tolerated by participants and the manualized BA counseling was readily applied by counselors without advanced mental health training, making the method potentially feasible in community settings.

Trauma and Growth: Impact of AIDS Activism.

INTRODUCTION: Our goal was to assess the long-term impact of AIDS activism of ACT UP/New York on the current adjustment of those who were members during its peak years (1987-1992), including assessment of trauma sequelae as well as posttraumatic growth. METHODS: A 90-minute semistructured interview and 6 validated self-report scales were administered. We relied on purposive and snowball sampling to recruit potential participants. Areas covered include demographics, ACT UP participation, and psychiatric problems. Self-report scales provided approximate diagnoses of PTSD and depression, as well as coping, optimism, and related concepts. RESULTS: Participants included 102 men (40% HIV-positive) and 23 women. Seventeen percent reported current symptoms suggesting PTSD, slightly above the range in general population studies. Symptoms consistent with depression were reported by 8% overall, with higher rates for HIV+ men. Enhanced sense of self, belief in change, and empowerment were reported by 93% of respondents, independent of concurrent PTSD or depression. CONCLUSIONS: Twenty-eight years later, ACT UP study participants recall their activist days during the AIDS epidemic as the peak experience of their lives. While some continue to have symptoms of stress and depression, most found that their activism has enriched their subsequent lives.

Placebo-controlled trial of dehydroepiandrosterone (DHEA) for treatment of nonmajor depression in patients with HIV/AIDS.

OBJECTIVE: Subsyndromal major depressive disorder is common among HIV-positive adults. This study was designed to assess the efficacy of dehydroepiandrosterone (DHEA) as a potential treatment. METHOD: One hundred forty-five patients with subsyndromal depression or dysthymia were randomly assigned to receive either DHEA or placebo; 90% (69 of 77) of the DHEA patients and 94% (64 of 68) of the placebo patients completed the 8-week trial. The primary measure of efficacy was a Clinical Global Impression improvement rating of 1 or 2 (much or very much improved) plus a final Hamilton Depression Rating Scale score

Endocrine effects of oral dehydroepiandrosterone in men with HIV infection: a prospective, randomized, double-blind, placebo-controlled trial.

Dehydroepiandrosterone (DHEA) is commonly used by HIV-infected men, but its endocrine effects in this population are not well defined. We conducted an 8-week randomized, placebo-controlled trial to determine the effects of escalating doses (100-400 mg/d) of DHEA on the hypothalamic-pituitary-adrenal and hypothalamic-pituitary-gonadal axes, and on a number of metabolic parameters in 69 HIV-positive men (31 in DHEA-treated group, 38 in placebo group). High-dose (250 microg) corticotropin and luteinizing hormone-releasing hormone stimulation tests were carried out in all subjects. Fifty-four subjects (26 in the DHEA-treated group and 28 in the placebo group) also underwent optional corticotropin-releasing hormone test, and 67 subjects (31 in DHEA-treated group and 36 in placebo group) underwent optional low-dose (1 microg) corticotropin stimulation test. All tests were performed at baseline and at the end of week 8. Repeated-measures analysis of variance was used to analyze the data. We observed significant increases in circulating levels of DHEA, DHEA-sulfate, free testosterone, dihydrotestosterone, androstenedione, and estrone, and a decline in the serum concentration of sex hormone-binding globulin in the DHEA-treated group but not in the placebo group (P < .001). There were no differences between the groups in other endocrine or metabolic parameters or in the results of the stimulation tests. In conclusion, oral DHEA therapy in HIV-positive men significantly increases circulating levels of DHEA and DHEA-sulfate, free testosterone, dihydrotestosterone, androstenedione, and estrone and suppresses circulating concentration of sex hormone-binding globulin. Long-term studies are needed to assess the clinical significance of these hormonal changes in subjects with HIV infection receiving oral DHEA therapy.

Increase in body cell mass and decrease in wasting are associated with increasing potency of antiretroviral therapy for HIV infection.

With the advent of potent combination antiretroviral therapy (ART), there has been a reduction in the incidence of wasting. However, few studies have investigated specific body composition changes associated with these treatments. This study aimed to investigate longitudinally the association of increasingly potent ART with changes in body cell mass and wasting utilizing bioelectric impedance analysis (BIA). In this longitudinal cohort study, 159 HIV-positive men were assessed semiannually from 1995 to 1997 for body composition utilizing BIA, CD4 lymphocyte count, HIV viral load, medical and depressive symptoms. Wasting was defined as body cell mass/height below the 90th percentile based on HIV positive norms. ART potency at each visit was scored utilizing published clinical guidelines, ranging from 1 (0-1 antiretrovirals) to 5 (3 or more antiretrovirals including a potent protease inhibitor). Viral resistance testing was not used. The mixed-effects model and the generalized estimating equations approaches were used to determine longitudinal correlates of body cell mass and of wasting, respectively. Over the 2 years of follow-up, potent combination ART use increased from 6% to 79%. Concurrently, a significant increase in mean body cell mass and a reduction in prevalence of wasting were seen, while total body weight, fat mass, and total body water did not change. Increasingly potent ART was associated with significant increases in body cell mass and reduction in wasting. Other significant correlates of increased body cell mass included higher CD4 count and decreased severity of HIV-related symptoms, fatigue and depression. The current study found that higher potency ART taken for relatively short term (2 years) was associated with an increase in body cell mass and a reduction in wasting and that these changes were associated with both medical (CD4, HIV symptoms) and behavioral (fatigue, depression) improvements. One caveat is this study did not distinguish among types of potent ART regimens. Given only some antiretrovirals appear linked to many body composition changes, regardless of their effect on viral load, it may be the type of regimen used that accounted for the relationship seen between viral load and body composition changes.

Depression and wish to die in a multicenter cohort of ALS patients.

Our objective was to determine prevalence of depressive disorders and wish to die at the baseline visit of a longitudinal multisite study of patients with ALS. Structured telephone interviews were conducted with patients diagnosed in past 18 months at 16 U.S. ALS centers. Demographic, medical, psychiatric and other psychological measures were administered. Of 329 patients assessed, mean ALSFRS-R score was 36.6; 88% (289/329) had no depressive disorder, 7% (24/329) had minor depression, and 5% (16/329) had current major depressive disorder (DSM-IV criteria). Demographic, financial and employment factors were unrelated to depression, as were duration of ALS symptoms and respiratory status, although depressed patients had lower scores on the total ALSFRS-R (p = 0.004) and gross motor function (p < 0.001). Depressed patients reported less pleasure, greater suffering, weariness and anxiety, more stress, were less hopeful, felt less control over illness management, reported lower quality of life, more often had thoughts about ending their lives and hastening death (all p < 0.001). Of the 62 patients (19% of the sample) who expressed a wish to die, only 37% (23/62) were clinically depressed. In conclusion, depressive disorders are not necessarily to be expected of ALS patients. Wish to die is not always expressed in the context of depression and does not necessarily represent psychopathology as such.

Mood and substance use disorders in older adults with HIV/AIDS: methodological issues and preliminary evidence.

OBJECTIVE: To review methodological issues and available data regarding the prevalence of psychiatric disorders in HIV-positive people over the age of 50 years. RESULTS: We were unable to find any published data providing prevalence rates of depression and substance use disorders, the most common psychiatric disorders, for HIV-positive adults over 50 years, compared with HIV-seronegative adults over 50 years or HIV-positive adults under the age of 50 years. Epidemiological data from population studies in the United States and internationally consistently show a substantial decline in the rates of depression and substance use disorders with progressive age in the general population. Preliminary data in our small sample suggest that, unlike HIV-seronegative older adults whose rates of disorder decline substantially compared with younger adults, this decline was not observed for older HIV-positive adults. CONCLUSION: Given the relative infrequency of disorder and the need to control both for age and HIV status, a large-scale study with four groups is required: HIV-positive men and women under and over 50 years of age, and HIV-negative men and women under and over 50 years of age.

Predictors of employment of men with HIV/AIDS: a longitudinal study.

OBJECTIVE: To identify patterns and predictors of work status and number of hours employed in a group of men with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). METHODS: A total of 141 participants had semiannual neuropsychiatric, psychosocial, and medical assessments over a period of 30 months. These six occasions provided the basis for identifying patterns of employment (part-time, full-time, or unemployed). Those who completed neuropsychological testing, introduced at visit 4, constitute the sample used to identify predictors of number of hours employed, using multiple regression analysis with mixed procedure. RESULTS: Over 30 months, 20% were continuously employed full-time, another 9% were continuously employed part-time, and 40% were continuously unemployed. Employment status changed for 31%: 4% who worked at baseline stopped, 13% started or increased their hours, 8% decreased their hours, and 6% showed a fluctuating pattern. The major parameters consistently associated with unemployment or partial employment, in order of influence, were financial (disability benefits), psychiatric (past/current diagnosis of major depression and/or dysthymia), medical (physical limitations), cognitive (executive function), and education. In contrast, age, ethnicity, laboratory markers of HIV illness status, vocational rank, and past or current substance dependence did not predict work status. CONCLUSIONS: Overall, those who worked continued to work. However, despite improved health, most men who were unemployed at study baseline did not return to work. Structure of disability benefits, lifetime depressive disorder, physical limitations, and impairment in some areas of cognitive function each appear to represent significant barriers to work. Returning to work is evidently difficult, and clinicians may keep this in mind when recommending leaving work unless medically necessary. Specific interventions and policy changes regarding disability benefits may be needed to promote return to work for people with HIV/AIDS whose health is restored and who contemplate re-employment.