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PubMed1996

Traditional and alternative research designs and methods in clinical pediatric psychopharmacology.

OBJECTIVE: To review both traditional and alternative research designs and methods in pediatric psychopharmacology. METHOD: Study designs used in clinical trials in psychiatry were selected for review with the special considerations of pediatric psychopharmacological trials in mind. Where possible, a reference to a specific published trial in pediatric psychopharmacology was provided for each design. RESULTS: It appears that pediatric psychopharmacology trials require a relatively greater flexibility in design to avoid significant study biases. Alternative research designs may be preferable to the traditional approaches, particularly when the use of the latter may raise important issues of feasibility. CONCLUSIONS: Evolution of a clinical research hypothesis to a study protocol in pediatric psychopharmacology is a manageable task if one keeps in mind essential elements such as selection of study design, population, sample size, treatment duration, and efficacy assessments.

Adolescent↗

PubMed2003

Developing strategies for psychopharmacological studies in preschool children.

OBJECTIVE: To identify the obstacles and special challenges-ethical, practical, scientific, and regulatory-faced by investigators who attempt to conduct psychopharmacological studies in preschoolers. METHOD: In a workshop held at the 47th Annual Meeting of the American Academy of Child and Adolescent Psychiatry, featuring interactive sessions designed to elicit discussion of the theory and feasibility of research in this young population, several key domains were identified: diagnosis and assessment, ethics, research design, special considerations for preschoolers, regulatory/industry issues, and education/training. RESULTS: A Pediatric Psychopharmacology Initiative is needed to consolidate recommendations from this and other workshops and current federal, research, and regulatory committees. A scholarly review and a guide for institutional review boards and investigators should be prepared on issues related to preschoolers. Developmental specialists provide valuable expertise that can strengthen studies of pediatric psychopharmacology. "N of 1" case studies can provide valuable information to clinicians. Only preschoolers with severe symptoms that occur in several interpersonal contexts should be entered into trials. Indications for the study of symptom complexes (e.g., aggression) rather than specific diagnoses should be examined and considered for regulatory activities. Psychopharmacology practice parameters for preschoolers are needed. CONCLUSIONS: With preschoolers being increasingly treated with psychopharmacological agents, the need for investigations to address the safety and efficacy of these medications is becoming a central issue for researchers from many disciplines.

Adolescent↗

PubMed2000

Cancer-related depression: Part II--Neurologic alterations and evolving approaches to psychopharmacology.

PURPOSE/OBJECTIVES: To describe evolving psychopharmacologic options for managing depression related to cancer. DATA SOURCES: Literature review and case study. DATA SYNTHESIS: Optimal recovery from depression requires early detection and selection of psychopharmacologic agents--singly or in combination--to address each depressive symptom. CONCLUSIONS: Adequate psychopharmacologic management of depression requires consistent, informed involvement of healthcare professionals, patients, and caregivers. Patients and caregivers need to be prepared to assess responses to therapy, recognize adverse effects, manage minor side effects and threats to adherence, and seek appropriate assistance for adverse events, including drug-drug interactions. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses need to take an active role in assessing, documenting, and monitoring patients' responses to antidepressants, particularly during key phases (e.g., induction, substitutions, augmentation, withdrawal). Nurses also need to take an active role in screening patients for depression, preparing patients and caregivers for psychopharmacologic management of depression, and reinforcing these competencies regularly. Oncology nurses also can be instrumental in recognizing signs and symptoms of treatment resistance and addressing these issues appropriately. Because of the rapid pace of psychopharmacologic research, oncology nurses need to update knowledge continuously to provide safe care to depressed patients with cancer.

Antidepressive Agents↗

PubMed1994

Teaching clinical psychopharmacology on an inpatient psychiatric research center.

In this article we have shown how an inpatient Psychiatric Clinical Research Center has been used successfully to teach medical students and residents some basic principles of clinical psychopharmacology. Although teaching effectiveness and resident acceptance of the program have not been measured objectively (we intend to do this in the next 2 years), informal feedback about the CRC rotation has been enthusiastic. The clinical psychopharmacology curriculum in our department has been enhanced by the experience of trainees on a research unit. In the rapidly expanding area of psychopharmacology, where new drugs are continually coming on the market, the CRC provides an opportunity to demonstrate the biopsychosocial model and to explore the interface between the research and clinical aspects of psychopharmacology.

Academies and Institutes↗

PubMed2003

Teaching ethics of psychopharmacology research in psychiatric residency training programs.

RATIONALE: American psychiatric residency training programs are now required to teach principles of research ethics. This task is especially pressing in light of evolving guidelines pertaining to human subjects, including psychiatric patients, especially when psychopharmacology is involved. Residents need to understand principles of research ethics and implications of roles of psychiatrists as investigators and clinicians. OBJECTIVES: We consider major contemporary ethical issues in clinical psychiatric research, with an emphasis on psychopharmacology, and implications of addressing them within residency training programs. METHODS: We reviewed recent literature on ethical issues in clinical research and on medical education in bioethics. RESULTS: This report considers: (1) an overview of current training; (2) perceived needs and rationales for training in research ethics, (3) recommended educational content and methods; (4) issues that require further study (including demonstration of acquired knowledge, practice issues, and the treatment versus-investigation misconception); and (5) conclusions. Recommended components of residency training programs include basic ethical principles; scientific merit and research design; assessment of risks and benefits; selection and informed consent of patient-subjects; and integrity of the clinical investigator, including definition of roles, conflicts-of-interest, and accountability. Evaluation of educational effectiveness for both trainees and faculty is a recommended component of such programs. CONCLUSIONS: We recommend that psychiatric training include education about ethical aspects of clinical research, with a particular emphasis on psychopharmacology. These activities can efficiently be incorporated into teaching of other aspects of bioethics, research methods, and psychopharmacology. Such education early in professional development should help to clarify roles of clinicians and investigators, improve the planning, conduct and reporting of research, and facilitate career development of much-needed clinical investigators in psychiatry.

Bioethics↗

PubMed1979

Ethics of psychopharmacological research.

1. Psychiatry is in dire need of research in all areas--from psychopharmacology to psychotherapy. 2. It is unethical not to undertake research as long as hundreds of thousands of patients suffer from incapacitating mental disorders. 3. It is unethical not to apply proper research principles to obtain maximal information from the observations of patients treated by different drugs or techniques. 4. The Tokyo (Helsinki II) declaration takes cognizance of the special problems in psychiatric (and certain other areas of) research, and should help to heighten the standard of all clinical research. 5. Psychopharmacology is based on the principles of the biological sciences. In the behavioral aspects of clinical psychopharmacological research non-objective observations cannot solely be based on these principles, but we should always be able to aim at: a. Description of spontaneous history. b. Description of diagnostic and therapeutic techniques and processes. c. Description of goals. d. Description of results (with as detailed information on treatment failures as on treatment successes). e. Prospective studies instead of retrospective ones. 6. Psychopharmacology is probably the area within psychiatry where the ethical issues have been most protected against the uncritical introduction of unproven therapeutic principles.

Ethics, Medical↗

PubMedDate not supplied

Mentoring treatment teams to integrate behavioral and psychopharmacological treatments in developmental disabilities.

Individuals with developmental disabilities often have a concomitant psychiatric disorder severe enough to require treatment. The behavioral endpoint of psychiatric disorders may require integrated behavioral and psychopharmacological treatments to stabilize their condition and enhance their quality of life. We used a mindfulness-based mentoring model to facilitate the integration of behavioral and psychopharmacological treatments at the treatment team level. Using a multiple baseline design across treatment teams, we assessed the degree of integration of these two treatment modalities using a 23-item rating scale, and then introduced mentoring successively across the three treatment teams. Following mentoring, six follow-up assessments at monthly intervals were undertaken to assess functioning of the treatment teams in the absence of mentoring. The low levels of integration of behavioral and psychopharmacological treatments occurring during baseline improved significantly within each team commensurate with the mentoring. Further, the enhanced treatment team functioning was maintained during a 6-month follow-up period. Mentoring of treatment teams may be an effective first step in integrating behavioral and psychopharmacological treatments that are deemed essential in the care and treatment of individuals with developmental disabilities and mental illness.

Behavior Therapy↗

PubMed2003

Review of safety assessment methods used in pediatric psychopharmacology.

OBJECTIVE: Elicitation is an essential and critical step in ascertaining adverse events (AEs). This report reviews elicitation methods used in published clinical trials of psychopharmacological agents in children. METHOD: Pediatric psychopharmacology reports were reviewed for safety methods in the Medline database. Studies were included if they were published 1980 or later, provided data on AEs, and described the ascertainment methodology used for determining them. RESULTS: A review of 196 pediatric psychopharmacology articles depicting safety assessments in clinical studies over the past 22 years revealed that there was no common method used for eliciting or reporting AE data. CONCLUSION: The current inconsistency in safety data ascertainment is a major limitation that likely impairs the ability to promptly and accurately identify drug-induced AEs. Research on how best to standardize safety methods should be considered a priority in pediatric psychopharmacology.

Adolescent↗

PubMed2006

Child and adolescent psychopharmacology in the new millennium: a workshop for academia, industry, and government.

OBJECTIVE: To give academic researchers, government officials, and industry scientists an opportunity to assess the state of pediatric psychopharmacology and identify challenges facing professionals in the field. METHOD: Increased federal spending and the introduction of pediatric exclusivity led to large increases in pediatric psychopharmacology research in the 1990s. Despite the increase in research, concerns exist about methods and incentives for making new medications available for use in pediatric psychiatric disorders. In recognition of these concerns, the Duke Clinical Research Institute held a roundtable in September 2004. Participants from the National Institutes of Health, regulatory agencies, academia, and the pharmaceutical industry spoke about the effects of government regulations such as the U.S. Food and Drug Administration Modernization Act and the Pediatric Research Equity Act on pediatric research from academic, clinical, and industry perspectives, and bioethical considerations of such research. CONCLUSIONS: To ensure development of new drugs for treating psychiatric disorders in children and adolescents, we must address the challenges posed by the regulatory environment governing pediatric psychopharmacology research. Strategies were identified for improving the evidence base for psychopharmacologic interventions in youth before widespread use and for more effectively defining a research agenda for the future.

Adolescent↗

PubMedDate not supplied

Teaching the prescriber's role: the psychology of psychopharmacology.

OBJECTIVE: The author examines one aspect of the psychopharmacology curriculum: the psychology of psychopharmacology. METHOD: Drawing from his experience teaching this subject to trainees at many different levels and from an emerging evidence base suggesting that psychosocial factors in the doctor-patient relationship may be crucial for medication effectiveness, the author explores the importance of this often overlooked aspect of pharmacotherapy. Several methods for teaching the integration of meaning and medication are examined. RESULTS: Generally, residents receiving thorough instruction in the psychology of psychopharmacology believe that they are not only better equipped to integrate psychotherapy and medications, but that this instruction enhances their skills as psychopharmacologists and psychotherapists. CONCLUSION: Teaching the psychodynamics of psychopharmacology addresses not only residents' needs to become more effective prescribers, but, in part, it may also address predictable developmental crises in residency.

Curriculum↗

PubMed1979

Psychopharmacology education in psychiatry.

This study has documented resident dissatisfaction with education in psychopharmacology in one large university and has proposed several solutions. These include: - increased awareness of standards of knowledge necessary for a consultant. - the establishment of a central educative office of clinical psychopharmacology to encourage dissemination of selected literature and to facilitate residents' research under supervision. - recognition that not all staff should be considered capable to provide psychopharmacology supervision and that each hospital should have a designated psychiatrist with special expertise in psychopharmacology. - developing study groups for the purpose of teaching critical evaluation of the literature. - increasing encouragement for residents' participating in clinical research - awareness of residents' difficulties in learning "emotional illness, rejection of biological therapies, and knowing what is expected or not suited to psychiatry" and appropriate actions to alter these. - increased use of audio aids, self-teaching manuals and journals to augment lectures and texts. - increased emphasis on training selected senior residents in how to teach.

Humans↗

PubMed1999

Psychopharmacology RACE: a fun road to competence.

1 In this era of rapidly changing mental health services and new psychotropic drugs, health professionals are challenged to develop and maintain psychopharmacology competencies. 2 The Psychopharmacology RACE provides an interactive and learner-oriented method of developing and assessing theoretical and clinical competencies for psychopharmacology. 3 The Psychopharmacology RACE is also well suited for modification and application toward the professional development of nurses and the education of clients.

Clinical Competence↗

PubMed2006

Ecological momentary assessment: what it is and why it is a method of the future in clinical psychopharmacology.

Current methods of assessment in clinical psychopharmacology have several serious disadvantages, particularly for the study of social functioning. We aimed to review the strengths and weaknesses of current methods used in clinical psychopharmacology and to compare them with a group of methods, developed by personality/social psychologists, termed ecological momentary assessment (EMA), which permit the research participant to report on symptoms, affect and behaviour close in time to experience and which sample many events or time periods. EMA has a number of advantages over more traditional methods for the assessment of patients in clinical psychopharmacological studies. It can both complement and, in part, replace existing methods. EMA methods will permit more sensitive assessments and will enable more wide-ranging and detailed measurements of mood and behaviour. These types of methods should be adopted more widely by clinical psychopharmacology researchers.

Data Collection↗

PubMed1994

[Current tasks of psychopharmacology].

The basic principle of psychopharmacology--is its impact on the psychopathological syndrome, having in view its specificity, expressivity of negative disturbances, nosological entity. One of the approaches to the selection of adequate psychopharmacotherapy may be the concept of comorbidity of disturbances, determining the structure of the syndrome and perspectives of its impact. With this in view, the structure of some syndromes may be considered not as a complex of closely interrelated disturbances, but as states stemming from relatively independent pathological disturbances, connected by probable relations. The problem of differentiated psychopharmacotherapy in line with the phenomenon of comorbidity at the level of symptom-syndrome, psychopathological personality disturbances (including negative ones), may have a practical as well as a theoretical significance. An analysis of comorbid connections determines as well the selection of preventive drugs in the prophylaxis of relapses of psychoses. An eventual study of all sides of this problem has its goal to define the spectre of action of the already known drugs and new psychopharmacological preparations, a deeper understanding of psychopathology and the clinical state being under the impact of psychopharmacological therapy, a transition from an extensive understanding of a wide range of questions of psychopharmacology to an intensive study of separate facets of the problem, which seems to be most perspective.

Adolescent↗

PubMed1983

Periadolescence: age-dependent behavior and psychopharmacological responsivity in rats.

The behavior and psychopharmacological sensitivity of periadolescent rats are examined in this review. Periadolescent rats are hyperactive and engage in more conspecific play behavior than younger or older rats. When compared with other-aged rats, periadolescents exhibit enhanced performance in simple active-avoidance learning tasks, but perform poorly in more complex appetitive and avoidance learning tasks in which increases in locomotor activity do not improve performance, perhaps as a result of age-specific alterations in selective attention or stimulus processing. Such behavioral "anomalies" of periadolescent animals observed in traditional laboratory situations may be in some way adaptive when considered in the context of the animals' natural habitat. In terms of psychopharmacological responsiveness, periadolescent rats, when compared with younger or older animals, are less sensitive to catecholaminergic agonists but are more responsive to the catecholaminergic antagonist haloperidol. This pattern of psychopharmacological sensitivity suggests that the catecholaminergic systems may be temporarily hyposensitive during the periadolescent period. Evidence is presented that a negative feedback system in the form of dopamine autoreceptors may become functionally mature in mesolimbic brain regions during the periadolescent period. The possibility is presented that maturation of these self-inhibitory autoreceptors might result in a temporary decrease in the efficacy of mesolimbic dopamine projections, perhaps contributing to the psychopharmacological and behavioral characteristics of periadolescent animals. In support of this suggestion, evidence is reviewed indicating that the behavior of adult animals with lesions of the ventral tegmental area, a region containing cell bodies from which these mesolimbic dopaminergic projections originate, resembles that of periadolescent rats.

Age Factors↗

PubMed1996

Psychopharmacology for dermatologic patients.

In the recent past, there has been great progress made in making psychopharmacologic agents both more efficacious and more user friendly. If dermatologists are to more effectively treat psychodermatologic patients who refuse to see a mental health professional, judicious and responsible use of psychopharmacology is still the most feasible way to treat many of these patients. This article illustrates the use of several commonly used psychopharmacologic agents. Even for psychiatrists, it is not realistic to try to master all psychopharmacologic agents that are on the market. Familiarity with the use of medications discussed in this article is likely to add significantly to the therapeutic armamentarium of a dermatologic practitioner.

Antipsychotic Agents↗

PubMed1997

Psychopharmacologic Management of Psychiatric Disorders in Patients with Diabetes Mellitus.

Diabetes mellitus is accompanied by multiple complications involving multiple organ systems. The Diabetes Control and Complication Trial (DCCT) has established the impact of intensive control in the emergence and progression of diabetic complications. Psychiatric disorders in patients with diabetes present a significant challenge and obstacle to glycemic control, and are a source of significant challenge and obstacle to glycemic control, and are a source of significant distress. Psychopharmacologic management of these disorders requires attention to their potential side effects, interactions with other agents, and the impact of psychopharmacologic management on glycemic control. Unfortunately, data regarding the direct impact, benefits and risks of psychopharmacologic agents are largely based on clinical experience and few controlled studies. General principles regarding the management of psychiatric disorders in the "medically-ill" need to be considered along with available data regarding the impact of psychopharmacologic interventions in patients with diabetes.

Journal Article↗

PubMed1989

The interface of clinical psychopharmacology and psychopathology.

Four areas of common interest for clinical psychopharmacology and psychopathology are identified: (1) the diagnostic-based approach in clinical psychopharmacology; (2) the characterization of psychotropic drugs according the main psychopathologically defined target symptoms; (3) prediction of treatment response; (4) development of rating scales. The current state of research strategies in these areas is discussed and the need for new strategies is stressed. In particular, diagnosis-based research strategies in clinical psychopharmacology are not fully justified by empirical data; an alternative approach is discussed.

Humans↗