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PubMed2003

Schizophrenia patients' and psychiatrists' perspectives on ethical aspects of symptom re-emergence during psychopharmacological research participation.

RATIONALE: Study designs involving medication-free intervals have become the subject of controversy in the current dialogue on the ethics of serious mental-illness research. METHODS: Schizophrenia patients ( n=59; response rate 75%; 48% inpatients) and psychiatrists ( n=70; response rate 83%) responded to ten questions about a hypothetical scenario in which a schizophrenia study participant experienced the re-emergence of serious symptoms during the "wash-out" phase of a psychopharmacological trial. Patients provided their personal views, and psychiatrists gave their personal views and made predictions as to how schizophrenia patients in general would respond. RESULTS: Schizophrenia patients and psychiatrists judged the hypothetical protocol as moderately harmful. Both expressed relatively low likelihood of willingness to participate in the study, given this potential outcome. Schizophrenia patients and psychiatrists found the decision fairly easy. Psychiatrists underestimated the level of harm and overestimated the difficulty of the decision as perceived by schizophrenia patients. Schizophrenia patients acknowledged that the offer of money and request by their doctor or family would increase the likelihood of their participation, and psychiatrists accurately predicted these responses. In hypothetical decisions about the symptomatic study participant, 38% of patients and 39% of psychiatrists said they would allow him to leave the hospital. A majority of both groups (63% and 52%, respectively) indicated that medication should be given despite the study participant's objection. Psychiatrists incorrectly predicted this response, expecting instead that most schizophrenia patients would support the discharge request and few would support involuntary administration of medication. Patients and psychiatrists offered similar reasons for participation decisions but differed in their strategies for handling the situation. CONCLUSION: These findings suggest potential strengths of decisionally capable schizophrenia patients in assessing ethically important design elements of psychopharmacological trials. Implications for informed consent for research, expectations of the therapeutic obligations of clinical investigators, and the role of psychiatric advance directives in psychopharmacological research are outlined.

Adult↗

PubMed2003

Ethical considerations in psychopharmacological research involving children and adolescents.

RATIONALE: Increased community utilization of psychotropic medications among children has brought attention to pediatric psychopharmacology research and associated ethical issues. OBJECTIVES: To discuss ethical aspects of child participation in psychopharmacology protocols. METHODS: Selective review of relevant scientific and regulatory literature. RESULTS: Efficacy and safety of psychotropics in children cannot be entirely inferred from adult data and direct participation of children in research is necessary. Child research must follow special regulations that are in addition to those common to all human research. For research with prospect of direct benefit, a critical factor is whether the risk/benefit ratio is favorable to the participating child. For research without such a prospect, the concepts of minimal risk and minor increase over minimal risk apply. However, the interpretation and application of these principles to specific protocols vary across settings and among ethics committees. Thus far, little empirical investigation has been conducted on children and parents' motivation for research participation, effectiveness of the informed consent and assent procedures, possibility of persistent consequences of exposure to experimental treatments and placebo, and validation of the concepts of minimal risk and minor increase over minimal risk. CONCLUSIONS: Research on human subject issues relevant to child participation is a promising approach to improving ethical methods and procedures of pediatric psychopharmacology.

Adolescent↗

PubMed2003

Beyond the question of placebo controls: ethical issues in psychopharmacological drug studies.

RATIONALE: There is a broad range of complex ethical issues in the conduct of psychopharmacological drug studies that go beyond the question of the ethics of placebo controls. However, our empirical knowledge with respect to these issues is very limited. This review, although not exhaustive, highlights an array of ethical issues that arose from discussions within the NIMH Human Subjects Research Council Workgroup. OBJECTIVES: To delineate issues in psychopharmacological drug studies that require debate and would benefit from research leading to the development of empirically-supported guidelines. METHODS: Information included in this report was drawn from the first author's participation as chair of the NIMH Human Subjects Research Council Workgroup, guidelines for the ethical conduct of research proposed by professional organizations to which the first and third author belong, and relevant research literature. RESULTS: We have focused on general issues relating to informed consent, research with special populations, and long-term treatment studies. Additionally, we raise issues relevant to large research-oriented institutions. CONCLUSIONS: The essential ethical challenge in psychopharmacological trials is to balance risks and benefits in the context of the needs and capacities of individual research subjects. The IRB system must become evidence-based and not rely on unproven assumptions. Specific research studies should be undertaken to address many of the issues of informed consent and research ethics postulated in this paper.

Adolescent↗

PubMed1995

Psychopharmacology: finding one's way.

The paper recalls the experiences of the author over the past forty-eight years in a field which later became known as psychopharmacology. The author began in physical chemistry and traditional pharmacology. His interest in the nervous system stemmed from X-ray diffraction studies on the structure of living myelin, and led, by way of studies on the distribution of cholinesterases and the effects of atropine, to the study of the effects of drugs on the electrical activity of the brain in the conscious animal. At the clinical level it included studies of the effects of drugs on catatonic schizophrenic stupor. These studies took place before the discovery of chlorpromazine. They led to the creation, in 1951, of the Department of Experimental Psychiatry in Birmingham, England, the first department of its kind in the world. The department included neurochemical, electrophysiological, and animal behavior laboratories and a strong clinical facility (the Uffculme Clinic). The first blind trial of chlorpromazine was carried out in that department in 1953 and 1954. The existence of families of neuroregulatory compounds, having uneven distribution in the brain, and exerting regional chemical field effects in relation to function was postulated on the basis of experimental and clinical findings. The work of colleagues and participants in the various studies is gratefully acknowledged in the text. In 1954 the author served as convening executive secretary of the first International Symposium on Neurochemistry at Oxford, England, the first meeting of its kind. He came to the United States in 1957 and founded, and served as first director of, the new Clinical Neuropharmacology Research Center, now the Center for Neuroscience at St. Elizabeth's Hospital, Washington, DC. He directed this program from 1957 to 1963. Subsequent activities at Johns Hopkins, the World Health Organization, and the International Brain Research Organization (IBRO) are recalled. In 1961 he was elected first president of the American College of Neuropsychopharmacology. In looking back, he notes the sparse and personal nature of the field in the late 1940s and early 1950s, its explosive growth in the wake of the major clinical discoveries, and above all, the emergence of a new science through the interaction of neurochemistry, electrophysiology, studies of animal behavior, and the refinement of the clinical trial. He regards the emergence of concepts of regional chemistry of the brain as particularly significant, and feels that psychopharmacology is ideally positioned to act as an intermediary between classical pharmacology and quantrum biology. The transdisciplinary nature of psychopharmacology provides a template for a comprehensive psychiatry of the future--a discipline which is now positioned to lead.(ABSTRACT TRUNCATED AT 400 WORDS)

England↗

PubMed2005

Psychotherapy in controlled psychopharmacology trials. Does it matter if we ignore it?

The controlled trial is now the standard for assessing efficacy of new treatments in Psychiatry, as it is in the rest of medicine. Psychiatric outcomes with treatment are influenced by concurrent psychosocial factors. Psychotherapy, alone or in combination with pharmacotherapy is an effective treatment. Thus, if concomitant receipt of psychotherapy is not controlled for in a psychopharmacology trial, outcome may be biased. In this study, all peer reviewed journal articles describing the results of randomized, controlled psychopharmacology trials in two separate years were carefully reviewed to assess the possible influence of control versus lack of explicit control for effect of concomitant psychotherapy on clinical outcome. One hundred sixteen articles, published in the years 1996 and 2000, were reviewed. Those with categorically positive or non-positive global outcome were assessed for description of concomitant receipt of psychotherapy by subjects randomized to different pharmacotherapy treatments. Description of comparability in potentially confounding demographic and clinical variables was present in all studies. Only 22% of 89 studies meeting inclusion criteria explicitly controlled for concomitant psychotherapy. Seventy five percent of 20 studies that did, and only 46% of 69 studies that did not, found different outcomes in groups randomized to different pharmacotherapy interventions (p=.024). This result was not accounted for by other aspects of study design such as placebo-vs.-active control comparison, trial size, length, geographic location, number of sites or authors, source of funding, or diagnostic composition)-suggesting that uncontrolled receipt of psychotherapy may reduce likelihood of finding a difference between a new treatment and a control pharmacotherapy intervention. If confirmed by further investigation, the results may warrant adoption of relevant recommendations for controlled trial design in psychopharmacology research. The method used in this report may be useful in other areas of controlled trial research to assess influence of confounding variables.

Bias↗

PubMed2002

Experimental and clinical psychopharmacology: National Institute on Drug Abuse's clinical research agenda.

Studies of drugs and behavior are a core component of virtually every portfolio within the broad purview of the National Institute on Drug Abuse (NIDA). Moreover, psychopharmacological research is an important vehicle for advancing understanding of how drugs of abuse produce their effects, particularly including addiction. However, as with all major public health issues, simply understanding the issue is not enough. NIDA's psychopharmacology projects, therefore, span basic, clinical, and applied (e.g., medication development) research activities. These include the establishment of a nationwide clinical trials network designed to provide an infrastructure to test both behavioral and psychopharmacological treatments in a real-life practice setting with diverse patients.

Acquired Immunodeficiency Syndrome↗

PubMed2005

Continuity and discontinuity in the historical development of modern psychopharmacology.

In the middle of the twentieth century psychiatry underwent a transition that is often referred to as the "psychopharmacology revolution." Implicit in the term revolution is the idea that a paradigm shift occurred. Specifically, it has been argued that psychiatry abandoned the psychoanalytic paradigm in favor of a qualitatively distinct conceptual system based on brain chemistry. The validity of this view requires that psychoanalysis had the status of a paradigm. This paper presents evidence that psychoanalysis did not constitute a paradigm and that the advent of psychopharmacology was not, technically, a scientific revolution. Instead, the rise of modern psychopharmacology was the culmination of a linear growth of biological knowledge that began to develop in the nineteenth century.

History, 20th Century↗

PubMed1997

Treatment algorithms in child psychopharmacology research.

Clinical trials in child psychiatry research have increased in complexity. Several factors have contributed to this change, including the need to compare multiple therapies, to re-create clinically relevant situations in research, to standardize treatment approaches, to account for the impact of comorbidity, to respond to the needs of individual patients, and to optimize treatment accordingly. To preserve the clinical and internal validity of the experimental interventions vis-à-vis their increasing complexity, researchers have started developing treatment algorithms. These deductive systems for handling data allow us to standardize and incorporate clinical judgment into study designs through the adoption of a stepwise decision making process. Treatment algorithms are different from treatment guidelines. Guidelines are general recommendations that apply to groups of patients with certain characteristics; they are not fully detailed and are created with the expectation that clinical judgment will be applied in individual cases. Algorithms are patient specific, are intended to capture all the relevant details of the clinical situation, and require minimal clinical judgment for their clinical application; they are designed to minimize the role of clinical judgment in research protocols. The entire multistep algorithm is tested in a clinical trial, not the single steps that constitute the algorithm, so proving the efficacy of an algorithm cannot replace a controlled assessment of the individual treatments embedded in the algorithm. Some characteristics, properties, and limitations of algorithms in child psychiatry and psychopharmacology research are presented along with two examples of algorithms currently used in child and adolescent psychopharmacology. Although treatment algorithms seldom have been used in pediatric psychiatry and psychopharmacology, there are indications that their use will increase in the near future and will allow the standardized introduction of clinical judgment into research design.

Adolescent↗

PubMedDate not supplied

Current approaches to the psychopharmacologic treatment of depression in children and adolescents.

TOPIC: A review of major depressive disorder and antidepressant drug treatment in children and adolescents. PURPOSE: This paper provides a synthesis of current information regarding diagnosis, psychobiology, psychopharmacology, and practice guidelines for psychiatric nurses involved in the treatment of depression in children and adolescents. SOURCES: Recent journal and book publications regarding the psychopharmacological treatment of depression in children and adolescents. CONCLUSION: Although there is far less research to guide the psychopharmacological treatment of depression in children and adolescents than there is for adults, these treatments can be safely administered and effective for some individuals in this age group.

Adolescent↗

PubMedDate not supplied

Alternate methods of teaching psychopharmacology.

OBJECTIVE: This article reviews methods used to teach psychopharmacology to psychiatry residents that utilize principles of adult learning, enlist active participation of residents, and provide faculty with skills to seek, analyze, and use new information over the course of their careers. METHODS: The pros and cons of five "nonlecture" methods of teaching are reviewed: 1) journal clubs, 2) problem-based learning, 3) formalized patient-centered training, 4) games, and 5) the use of modern technology. RESULTS: Several programs are beginning to find novel methods of teaching psychopharmacology that are effective and well received by trainees and faculty. CONCLUSION: Programs need to go beyond the traditional lecture and apprenticeship model of psychopharmacology education to help make learning more fun, useful, relevant and self-sustaining.

Curriculum↗

PubMed1998

Contemporary ethical dilemmas in psychotherapy: cosmetic psychopharmacology and managed care.

Two contemporary ethical dilemmas facing psychotherapists have been noted and described: cosmetic psychopharmacology and the practice of psychotherapy in a managed care environment. Regarding cosmetic psychopharmacology: It was noted that whether a psychotherapist endorses the use of psychotropic agents for cosmetic purposes, such as self-transformation, seems to be a function of the severity of the client/patient symptoms as well as the psychotherapist's view of human nature and the human condition. However, recent research indicates that certain traits or reflections of the human condition, such as irritability, may actually be neurotransmitter deficiencies that are responsive not only to psychotropic agents but also to non-drug interventions. These findings add an additional dimension to discussions of the ethics of cosmetic psychopharmacology. Regarding psychotherapy in a managed care environment: Several ethical dilemmas, including confidentiality, were discussed. These dilemmas were outlined rather than analyzed in detail. Some of them will become major "thorns" of concern for the practice of psychotherapy. Others will be less consequential. Of critical concern is that limitations by managed care on the technique and optimal length of treatment of psychotherapy can conceivably lessen its efficacy for some patients and could possibly eliminate this powerful treatment procedure for others.

Combined Modality Therapy↗

PubMed1983

The impact of psychopharmacology education on prescribing practices.

The authors describe a pharmacology education program on the psychiatry service of a Veterans Administration medical center. The program, directed by a clinical pharmacist, includes weekly lectures to medical students and weekly psychopharmacology review rounds for psychiatric residents that are also attended by staff psychiatrists. To determine the impact of the psychopharmacology review rounds on prescribing practices, the authors conducted a retrospective chart review of psychopharmacologic treatment methods before and after the rounds were instituted. The review compared prescribing practices in the two periods and focused particularly on changes in practices related to multiple daily dosages, polypharmacy, prophylactic anticholinergics, and drug use in alcohol withdrawal. The review demonstrated that the teaching effort resulted in a use of psychotropic medications that was more in line with recommendations in the literature.

Adult↗

PubMed1991

Psychopharmacology training in psychiatric residency programs: the Canadian scene.

A survey among psychiatric residents about their satisfaction with and concerns about their training in psychopharmacology was conducted. One hundred and seventy responders (61%) from ten post-graduate psychiatric programs in Canada completed the questionnaire. The questionnaire assessed the residents' satisfaction with the training they had received over the previous six months as well as over their entire residency period. The questionnaire inquired specifically about the quantity and quality of supervision in the use of different medications for different therapeutic purposes. It also looked at the quality of supervision of drug therapies within hospital services, inpatient, outpatient, consultation and emergency services. Residents also were asked about coverage of specific topics and ranked different methods of learning. The survey uncovered a number of deficiencies mostly related to the teaching of basic psychopharmacology, integration of psychopharmacological and psychosocial issues and the lack of teaching of clinical appraisal of recent advances. Factors that may have contributed to the development of such deficiencies as well as specific recommendations are discussed.

Attitude of Health Personnel↗

PubMed2001

Pediatric psychopharmacology.

This paper reviews research in pediatric psychopharmacology over the past decade. The authors first discuss social, economic, and other influences on pediatric psychopharmacology research and prescribing patterns including changing models of childhood psychopathology, increased government funding, and changes in industry regulations. Definitions are offered for current research terminology including efficacy, effectiveness, and adverse events. Design trends and new approaches to outcome measurement are also presented. New data from the last 10 years of research is reviewed for each major class of psychotropic agents. Criteria for inclusion in the review are presented and include aspects of study design (placebo-controlled, large sample size), source of funding (government funded vs. industry), and vision (creative applications). Data for short-term efficacy, long-term efficacy, effectiveness, and safety and adverse events are discussed for each class of medication, although for many, there remains little empirical data. Findings for stimulants, selective serotonin reuptake inhibitors, neuroleptics, alpha-adrenergic agonists, mood stabilizers, buproprion, secretin, naltrexone, immune therapies, and natural supplements are all presented. Finally, the authors offer some speculations regarding the future of pediatric psychopharmacology research.

Adolescent↗

PubMed1991

Psychopharmacology education software. The first of a series.

A psychopharmacology testing package was generated by Multiple Choice, a Claris HyperCard 2.1 based software application. Multiple Choice was developed specifically to allow for the simple preparation of non-networked computerized testing. It permits tests of unlimited length to incorporate true/false, multiple choice (with 3-5 possible answers), and K-type questions. These examinations may incorporate explanations if desired. The tests maintain records to more easily permit the examination's creator to quickly determine scores and question-specific results. The psychopharmacology testing package is a multi-level group of three examinations. It is to be the first in a series of psychiatry exams targeting medical students, psychiatry residents, and other interested professionals. Work is also in progress to convert both the psychopharmacology testing package and Multiple Choice itself to the PC-compatible platform.

Computer-Assisted Instruction↗

PubMed1990

[Canadian geriatric psychiatry and psychopharmacology 1987-1988].

The paper offers a brief outline of the current state of geriatric psychiatry and psychopharmacology in Canada and partially in the USA. Major trends are described in clinical care, in organization and education, along with some basic historical comments. The important role of self-help groups is sketched. The contents of recent major scientific meetings illustrate the increasing emphasis in research in ageing, geriatric psychiatry and geriatric psychopharmacology. The developments are characterized by intimate connections between basic and applied research, and between clinical observations and experimental neurobiology. The analysis of developments in the current practice and research offers some insight into upcoming treatment strategies. The next decade in geriatric psychiatry will probably belong in particular to molecular biology, genetic, psycho-immunology and psychopharmacology.

Aged↗

PubMed1996

The interaction of ethnicity, sociocultural factors, and gender in clinical psychopharmacology.

There is increased interest in the role that ethnicity, sociocultural factors, and gender play in research, health care delivery, and response to intervention. The impact of these factors on AIDS awareness programs, on the phenomenology of suicide and anorexia nervosa, and on clinical psychopharmacology in a homogeneous population is discussed. Risky sex practices can be related to cultural norms that stigmatize condom use and sex education; economic deprivation; and male dominance. Gender, cultural, and ethnic demographics can identify high-risk groups as well as influence effective interventions. Suicide rates and risk factors are compared in African-American, Canadian Native, and South Korean adolescents. Academic stress was a differential risk factor for the Koreans. Anorexia nervosa predominantly affects women and has cultural differences in prevalence. The homogeneous population in Hong Kong illustrates the impact of ethnicity, sociocultural factors, and gender on clinical psychopharmacology. Attention to ethnicity, sociocultural factors, and gender can individualize and improve the effectiveness of clinical psychopharmacology.

Acquired Immunodeficiency Syndrome↗

PubMedDate not supplied

Psychopharmacologic management of women with common mental health problems.

This article reviews the essential aspects of the psychopharmacologic management of women with mental health problems, with particular emphasis on the role of the nurse-midwife as a primary care provider. The article also addresses the neurobiology of psychopharmacology, pharmacokinetics, and the selection of pharmacologic treatments used for depression, bipolar disorders, anxiety disorders, eating disorders, and psychosis. Considerations for the timely and appropriate referral for psychiatric intervention for women with psychiatric or pharmacologic emergencies are discussed, and issues relating to pregnancy, lactation, and reproductive health are included. The importance of the nurse-midwife's role in ensuring women's access to and compliance with psychopharmacologic therapy is emphasized.

Emergencies↗