Carl Salzman

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Publications (23)102.79 Total impact

  • Carl Salzman
    Journal of clinical psychopharmacology 12/2012; · 5.09 Impact Factor
  • Carl Salzman
    Journal of clinical psychopharmacology 12/2011; 31(6):688-9. · 5.09 Impact Factor
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    ABSTRACT: The aging of the world’s population has resulted in a new demographic phenomenon: a significant increase in the percentage of elderly compared with the general population. Between 1960 and 1990, the general population in the U.S. increased by less than 50%, while those over 65 increased by almost 100%, and those over 85 years of age increased by almost 250% (1).
    12/2010: pages 125-183;
  • Carl Salzman
    Journal of clinical psychopharmacology 10/2010; 30(5):485-6. · 5.09 Impact Factor
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    ABSTRACT: To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies of major depression, bipolar disorder, schizophrenia, substance abuse/dependence, and other psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this scholarly article, which has been developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement have been noted. The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's effort to promote standard definitions and definable expectations for investigators and industry sponsors by endorsing the terminology in the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to build upon its new authority to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk within informative large health care-related databases in the United States and abroad. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the current Agency requirement that all CNS clinical drug trials must include a C-CASA-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed, and they need to be included to enable premarket assessments of the risks and benefits of medications related to suicidal ideation, suicidal behavior, and suicide in such patients.
    The Journal of Clinical Psychiatry 08/2010; 71(8):e1-e21. · 5.81 Impact Factor
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    ABSTRACT: To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies in studies of psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement at the conference have been noted in the text. The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's encouragement of standard definitions and definable expectations for investigators and industry sponsors. Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the requirement that all central nervous system clinical drug trials must include a Columbia Classification Algorithm of Suicide Assessment (C-CASA)-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed.
    The Journal of Clinical Psychiatry 08/2010; 71(8):1040-6. · 5.81 Impact Factor
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    ABSTRACT: Atypical antipsychotic drugs have been used off label in clinical practice for treatment of serious dementia-associated agitation and aggression. Following reports of cerebrovascular adverse events associated with the use of atypical antipsychotics in elderly patients with dementia, the U.S. Food and Drug Administration (FDA) issued black box warnings for several atypical antipsychotics titled "Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients With Dementia." Subsequently, the FDA initiated a metaanalysis of safety data from 17 registration trials across 6 antipsychotic drugs (5 atypical antipsychotics and haloperidol). In 2005, the FDA issued a black box warning regarding increased risk of mortality associated with the use of atypical antipsychotic drugs in this patient population. Geriatric mental health experts participating in a 2006 consensus conference (Bethesda, Md., June 28-29) reviewed evidence on the safety and efficacy of antipsychotics, as well as nonpharmacologic approaches, in treating dementia-related symptoms of agitation and aggression. EVIDENCE/CONSENSUS PROCESS: The participants concluded that, while problems in clinical trial designs may have been one of the contributors to the failure to find a signal of drug efficacy, the findings related to drug safety should be taken seriously by clinicians in assessing the potential risks and benefits of treatment in a frail population, and in advising families about treatment. Information provided to patients and family members should be documented in the patient's chart. Drugs should be used only when nonpharmacologic approaches have failed to adequately control behavioral disruption. Participants also agreed that there is a need for an FDA-approved medication for the treatment of severe, persistent, or recurrent dementia-related symptoms of agitation and aggression (even in the absence of psychosis) that are unresponsive to nonpharmacologic intervention. This article outlines methodological enhancements to better evaluate treatment approaches in future registration trials and provides an algorithm for improving the treatment of these patients in nursing home and non-nursing home settings.
    The Journal of Clinical Psychiatry 06/2008; 69(6):889-98. · 5.81 Impact Factor
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    ABSTRACT: In elderly persons, antipsychotic drugs are clinically prescribed off-label for a number of disorders outside of their Food and Drug Administration (FDA)-approved indications (schizophrenia and bipolar disorder). The largest number of antipsychotic prescriptions in older adults is for behavioral disturbances associated with dementia. In April 2005, the FDA, based on a meta-analysis of 17 double-blind randomized placebo-controlled trials among elderly people with dementia, determined that atypical antipsychotics were associated with a significantly (1.6-1.7 times) greater mortality risk compared with placebo, and asked that drug manufacturers add a 'black box' warning to prescribing information for these drugs. Most deaths were due to either cardiac or infectious causes, the two most common immediate causes of death in dementia in general. Clinicians, patients, and caregivers are left with unclear choices of treatment for dementia patients with psychosis and/or severe agitation. Not only are psychosis and agitation common in persons with dementia but they also frequently cause considerable caregiver distress and hasten institutionalization of patients. At the same time, there is a paucity of evidence-based treatment alternatives to antipsychotics for this population. Thus, there is insufficient evidence to suggest that psychotropics other than antipsychotics represent an overall effective and safe, let alone better, treatment choice for psychosis or agitation in dementia; currently no such treatment has been approved by the FDA for these symptoms. Similarly, the data on the efficacy of specific psychosocial treatments in patients with dementia are limited and inconclusive. The goal of this White Paper is to review relevant issues and make clinical and research recommendations regarding the treatment of elderly dementia patients with psychosis and/or agitation. The role of shared decision making and caution in using pharmacotherapy for these patients is stressed.
    Neuropsychopharmacology 05/2008; 33(5):957-70. · 8.68 Impact Factor
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    ABSTRACT: How do we best teach clinical psychopharmacology to trainees and clinicians, so they not only increase their knowledge base, but even more importantly also learn to practice the most informed, evidence-based practice possible? This article attempts to answer this elusive question by compiling the individual and combined wisdom of 5 expert psychopharmacology teachers, each of whom draws on years of their own experiences as master educators. The topics covered include teaching clinical psychopharmacological competence in adult psychiatry residency training and in issues specific to both pediatric and geriatric populations, teaching physicians to improve clinical outcomes through continuing medical education, and new developments in adult-centered pedagogy and assessment. Although the focus of this article is on practical pearls found useful in teaching psychiatric residents and practicing physicians, the lessons learned are applicable to other groups of learners such as medical students, other trainees, and nonmedical clinicians. Our goal is to help educators produce competent psychopharmacology clinicians schooled in the latest evidence, capable of keeping up with new knowledge as it becomes available, and practicing both the art and science of expert clinical care.
    Journal of Clinical Psychopharmacology 03/2008; 28(1):96-100. · 3.51 Impact Factor
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    ABSTRACT: The most common complaints of older adults concern their difficulty initiating or maintaining sleep, which results in insufficient sleep and an increased risk of falls, difficulty with concentration and memory, and overall decreased quality of life. Difficulties sleeping are not, however, an inevitable part of aging. Rather, the sleep complaints are often comorbid with medical and psychiatric illness, associated with the medications used to treat those illnesses, or the result of circadian rhythm changes or other sleep disorders. Health care professionals specializing in geriatrics need to learn to recognize the different causes of sleep disturbances in this population and to initiate appropriate treatment. Nonpharmacological treatment techniques are discussed; pharmacological treatments are discussed in a companion article.
    Harvard Review of Psychiatry 01/2008; 16(5):279-86. · 3.50 Impact Factor
  • Carl Salzman
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    ABSTRACT: Disturbed sleep is common in the elderly, who, as a group, take a disproportionately large number of hypnotic medications. Benzodiazepine hypnotics, as well as the newer benzodiazepine receptor agonists, are the primary treatments for these late-life sleep disorders and are effective and safe when used within recommended prescribing guidelines. The elderly also receive other psychiatric medications to induce sleep, although these are off-label uses not well supported by research literature. There is also no literature support for the use of over-the-counter sleep preparations, although both melatonin and a melatonin receptor agonist appear to be moderately effective and safe. Prescribing guidelines for the elderly continue to emphasize short-term, low-dose use, with short-half-life medications. Hypnotic drugs should be used in conjunction with nonmedication treatments, including appropriate sleep hygiene practice, and treatment of other medical or psychiatric causes of disturbed sleep.
    Harvard Review of Psychiatry 01/2008; 16(5):271-8. · 3.50 Impact Factor
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    ABSTRACT: Treatment studies of depression in residential care are limited. Reports of predictors of response are rare. In the largest nursing home prospective antidepressant trial reported, we examined predictors of response. This was a 12-week open-label study of mirtazapine orally disintegrating tablets performed in 30 US nursing homes. Subjects were men and women aged >or=70, with a Mini Mental State Exam (MMSE) score >or=10, who had a depressive disorder that required antidepressant treatment. Mirtazapine was started at 15 mg at bedtime, and adjusted to 15-45 mg/day. A 16-item Hamilton Depression Rating Scale was used to assess depression at baseline, weeks 2, 4, 8, and 12 or early termination. One hundred and twenty-four patients received at least one dose of study drug and of these, 119 had at least one post-drug assessment. Mean age was 82.9 years and 72% were female. Response rates at 12 weeks were 47% on the HAMD and 54% on the CGI. Age, sex, MMSE score, medical burden, history of prior depression, and baseline HAMD severity were not significantly associated with HAMD response (>or=50% improvement) and in most cases correlations were trivial, <0.1. Advanced age, medical burden, and cognitive impairment did not predict adverse events. In this sample of depressed nursing home residents treated with mirtazapine orally disintegrating tablets, advanced age, medical illness, and cognitive impairment did not predict response. The findings suggest that these variables need not be viewed as obstacles to treatment.
    International Journal of Geriatric Psychiatry 10/2007; 22(10):999-1003. · 2.98 Impact Factor
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    ABSTRACT: The authors summarize two special sessions focused on the teaching of psychopharmacology at the 2003 and 2004 annual meeting of the American College of Neuropsychopharmacology (ACNP). The focus was on whether "improving the teaching-learning process" in psychiatric residency programs could improve clinical practice. Problems of strategies and pedagogic techniques that have been used were presented from multiple perspectives (e.g., from a dean, department chair, training director, and former students). There was a consensus that action involving psychopharmacology organizations and the American Association of Directors of Residency Training in Psychiatry (AADPRT) was necessary to improve "evidence-based" competencies before graduation and to follow prescribing patterns into clinical practice to determine whether the standards of care could be improved.
    Academic Psychiatry 01/2007; 31(3):211-7. · 0.81 Impact Factor
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    ABSTRACT: Atypical antipsychotics have become a common pharmacologic option for the treatment of various psychiatric and behavioral symptoms in older adults, although these medications have been officially approved by the U.S. Food and Drug Administration for use only in schizophrenia and bipolar disorder. Despite the widespread use of these agents, there is a relative shortage of rigorously conducted trials. This review focuses on recently published randomized, blinded, controlled trials involving the use of atypical antipsychotics in elderly patients with dementia (n = 9) or schizophrenia (n = 3), with some discussion of published large, open-label studies and a few unpublished controlled trials. In general, the studies of patients with dementia reported modest efficacy of atypical antipsychotics when compared to placebo and conventional antipsychotics. In addition, an advantage in terms of motor side effects was consistently noted with atypical antipsychotics when compared to conventional antipsychotics. The studies have also shown, however, a greater risk of mortality and adverse cerebrovascular events with several of these agents than with placebo in individuals with dementia. There are insufficient data comparing atypical antipsychotics to one another. In the trials involving elderly persons with schizophrenia, atypical antipsychotics were associated with significant improvements in psychopathology; differences in efficacy among atypical antipsychotics were unclear. A careful consideration of the risk-benefit ratio of atypical antipsychotics, as well as that of available alternative treatments, is needed for each individual elderly patient. Clinical judgment, caution, and consent should be the watchwords in this area of psychopharmacology.
    Harvard Review of Psychiatry 01/2005; 13(6):340-51. · 3.50 Impact Factor
  • Carl Salzman
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    ABSTRACT: The prevalence, natural course, risk profile, and treatment of anxiety disorders in the elderly are remarkably understudied. Anxiety disorders are less prevalent in the elderly than in younger adults, but rates of subsyndromal anxiety disorders in elderly persons are nearly as high as in their younger cohorts. The most common late-life anxiety disorders are mixed anxiety-depression and generalized anxiety disorder. Though the benzodiazepines are widely used in this population and are considered relatively safe given appropriate dosing and safety monitoring, important liabilities remain with the use of these agents. Antidepressants also are widely used in elderly patients, but there are no randomized controlled anxiety disorder treatment trials in this population. Gabapentin and low-dose atypical antipsychotics are beginning to be used and studies of the atypical antipsychotics are ongoing. Until studies are completed, treatment of late-life anxiety will continue to be guided by extrapolating data from the general adult population.
    Psychopharmacology bulletin 02/2004; 38 Suppl 1:25-30. · 1.35 Impact Factor
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    ABSTRACT: To review progress made during the past decade in late-life mood disorders and to identify areas of unmet need in health care delivery and research. The Consensus Development Panel consisted of experts in late-life mood disorders, geriatrics, primary care, mental health and aging policy research, and advocacy. (1) Literature reviews addressing risk factors, prevention, diagnosis, treatment, and delivery of services and (2) opinions and experiences of primary care and mental health care providers, policy analysts, and advocates. The Consensus Development Panel listened to presentations and participated in discussions. Workgroups considered the evidence and prepared preliminary statements. Workgroup leaders presented drafts for discussion by the Consensus Development Panel. The final document was reviewed and edited to incorporate input from the entire Consensus Development Panel. Despite the availability of safe and efficacious treatments, mood disorders remain a significant health care issue for the elderly and are associated with disability, functional decline, diminished quality of life, mortality from comorbid medical conditions or suicide, demands on caregivers, and increased service utilization. Discriminatory coverage and reimbursement policies for mental health care are a challenge for the elderly, especially those with modest incomes, and for clinicians. Minorities are particularly underserved. Access to mental health care services for most elderly individuals is inadequate, and coordination of services is lacking. There is an immediate need for collaboration among patients, families, researchers, clinicians, governmental agencies, and third-party payers to improve diagnosis, treatment, and delivery of services for elderly persons with mood disorders.
    Archives of General Psychiatry 08/2003; 60(7):664-72. · 13.77 Impact Factor
  • Carl Salzman
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    ABSTRACT: Lithium and several anticonvulsant medications play an important role in the treatment of bipolar mood disorder. Clinical observations and open clinical trials are beginning to suggest additional therapeutic roles for these drugs. The largest number of reports indicate a monotherapy antidepressant effect for lithium and for lamotrigine. There is also strong evidence for lithium's role in augmenting antidepressant therapy, with reports also suggesting an augmenting role for divalproex and for lamotrigine. The potential usefulness of these medications for 21 other conditions has been reported in the literature, primarily from small case series or open-label, uncontrolled trials.
    Harvard Review of Psychiatry 01/2003; 11(5):230-44. · 3.50 Impact Factor
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    ABSTRACT: To evaluate the efficacy and tolerability of mirtazapine orally disintegrating tablets in depressed, elderly nursing home residents, under naturalistic study conditions. In this open-label 12-week study, mirtazapine orally disintegrating tablets (15-45 mg/day) were administered to patients > or =70 years old with physician-diagnosed depression and a Mini-Mental State Examination (MMSE) score > or =10. Patients with medical comorbidities, cognitive impairment and/or concomitant medications were enrolled if they met study inclusion criteria and had illnesses and/or medication dosages that were considered stable. Assessments were performed at baseline by physicians and at days 14, 28, 56, and 84 (or early termination) by physicians or nurse coordinators using the Clinical Global Impression (CGI) scale, the 16-item Hamilton Rating Scale for depression (Ham-D-16 (the standard 17-item scale minus item 14)), and the Cornell Scale for Depression in Dementia (CSDD). Tolerability was evaluated based on treatment-emergent adverse events. A total of 119 patients in the intent-to-treat (ITT) group were treated with mirtazapine orally disintegrating tablets (mean daily dose: 19.4 mg) and evaluated for efficacy. At endpoint, 54% of patients in the ITT group showed CGI-I response (defined as a CGI-I score of 1 or 2 ('very much' or 'much' improved) and 47% were Ham-D-16 responders (defined as decrease from baseline of at least 50% in Ham-D-16 total score). CSDD mean scores and Ham-D-16 mean total scores demonstrated a progressive decrease from baseline to trial completion. The decrease in Ham-D scores from baseline to day 84 was statistically significant (p < 0.0001). Mean changes from baseline to day 84 were -6.6 +/- 6.9 (CSDD score) and -7.9 +/- 7.4 (Ham-D-16 total score). Ham-D Factor I, Factor VI and item 1 scores also decreased. Fourteen of 124 patients in the all-subjects-treated (AST) group (11.3%) discontinued prematurely due to adverse events. The most frequently occurring adverse events were urinary tract infection (19%), accidental injury (18%), fall (18%), somnolence (12%), and upper respiratory infection (12%). Mean body weight increased by 0.7 +/- 2.25 kg (1.54 +/- 5 lb) from baseline to day 28, and by 1.3 +/- 3.36 kg (2.86 +/- 7.4 lb) from baseline to day 84. The results suggest that mirtazapine orally disintegrating tablets provide antidepressant efficacy and are a relatively well-tolerated treatment for depression in this patient population of elderly nursing home residents with medical and cognitive comorbidities.
    Current Medical Research and Opinion 01/2003; 19(8):737-46. · 2.26 Impact Factor
  • Carl Salzman, Eileen Wong, B Cody Wright
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    ABSTRACT: A computer-based literature search of all antidepressant and electroconvulsive therapy (ECT) treatment studies published between 1995 and September 2001 was conducted. In addition, a review of published chapters, review articles, and metaanalyses was also conducted. Articles were categorized into those reporting comparative studies, those in which the therapeutic agent was not compared with another, articles about ECT, and review articles. These recent publications support the conclusions from prior reviews that antidepressants and ECT are effective and safe treatments for depressed elderly patients. Differences in efficacy and side effects appear to be slight among the various types of antidepressants. Research studies of depressed elderly increased markedly since 1995 compared with all previous years although more studies are still necessary.
    Biological Psychiatry 09/2002; 52(3):265-84. · 9.25 Impact Factor
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    ABSTRACT: Depression is common across a broad spectrum of severity among nursing home residents. Previous research has demonstrated the effectiveness of antidepressants in nursing home residents with major depression, but it is not known whether antidepressants are helpful in residents with less severe forms of depression. We conducted a randomized double-blind placebo-controlled 8-week trial comparing paroxetine and placebo in very old nursing home residents with non-major depression. The main outcome measure was the primary nurse's Clinical Impression of Change (CGI-C). Additional outcome measures were improvement on the interview-derived Hamilton Depression Rating Scale (HDRS) and Cornell Scale for Depression (CS) scores. Twenty-four subjects with a mean age of 87.9 were enrolled and twenty subjects completed the trial. Placebo response was high, and when all subjects were considered, there were no differences in improvement between the paroxetine and placebo groups. Two subjects that received paroxetine developed delirium, and subjects that received paroxetine were more likely to experience a decrease in Mini Mental State Exam scores (P =.03). There were no differences in serum anticholinergic activity between groups. In a subgroup analysis of 15 subjects with higher baseline HDRS and CS scores, there was a trend toward greater improvement in the paroxetine group in an outcome measure that combined the CGI-C and interview-based measures (P =.06). Paroxetine is not clearly superior to placebo in this small study of very old nursing home residents with non-major depression, and there is a risk of adverse cognitive effects. Because of the high placebo response and the trend towards improvement in the more severely ill patients, it is possible that a larger study would have demonstrated a significant therapeutic effect for paroxetine as compared with placebo. The study also illustrates the discordance between patient and caregiver ratings, and the difficulties in studying very elderly patients with mood disorders.
    Depression and Anxiety 02/2002; 15(3):102-10. · 4.61 Impact Factor

Publication Stats

556 Citations
225 Downloads
1k Views
102.79 Total Impact Points

Institutions

  • 2011–2012
    • Beth Israel Deaconess Medical Center
      Boston, Massachusetts, United States
  • 2001–2008
    • Harvard Medical School
      • Department of Psychiatry
      Boston, MA, United States
  • 2005
    • University of California, San Diego
      • Department of Psychiatry
      San Diego, CA, United States