Clinical psychopharmacology: advances and challenges from 1965 to 2006.
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Antidepressive Agents↗
Biomedical subjects
M Lynn Crismon
Publications and source records attributed to M Lynn Crismon.
Atomoxetine versus stimulants for treatment of attention deficit/hyperactivity disorder.
OBJECTIVE: To identify, review, and analyze studies comparing atomoxetine with psychostimulants with the intent of determining the role of atomoxetine in the pharmacologic management of attention deficit/hyperactivity disorder (ADHD). DATA SOURCES: Primary, review, and meta-analysis articles were identified by a MEDLINE search (1966-December 2005). MeSH headings used in the search include: attention deficit/hyperactivity disorder, ADHD, atomoxetine, stimulants, psychostimulants, methylphenidate, and amphetamine salts. Relevant data presented at professional meetings that we attended were also identified. STUDY SELECTION AND EXTRACTION: All clinical studies comparing atomoxetine with psychostimulants, regardless of study design, were evaluated. Relevant efficacy and safety data from these studies were included in the discussion. DATA SYNTHESIS: At time of writing, 5 head-to-head trials had compared psychostimulants and atomoxetine in the treatment of ADHD. No significant difference between atomoxetine and methylphenidate immediate-release were found on the ADHD Rating Scale total score. Osmotic oral release system (OROS) methylphenidate showed significantly greater improvement at weeks 1 and 2, and significantly more patients treated with OROS methylphenidate were classified as responders. Patients on both atomoxetine and mixed amphetamine salts extended-release (MAS XR) showed significant improvements at endpoint over baseline; however, Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scores were significantly better with MAS XR. Tolerability was similar between atomoxetine and stimulant medications. CONCLUSIONS: Based on available evidence, psychostimulants are regarded as first-line pharmacologic treatment for children and adolescents with ADHD, as the efficacy and safety of these agents have been well established based on clinical trials and extensive naturalistic use. Adverse effects in some patients and abuse potential have led to the search for new treatments. Atomoxetine represents an alternative treatment for ADHD and is unlikely to be associated with abuse; however, long-term safety data are needed to further establish its place in therapy.
Adrenergic Uptake Inhibitors↗
Ethnic variation in symptoms and response to risperidone in youths with schizophrenia-spectrum disorders.
BACKGROUND: Evaluation of symptom presentation and antipsychotic response based on ethnicity in children and adolescents with schizophrenia is limited. The purpose of this naturalistic, retrospective database study was to compare symptom presentation of children and adolescents of different ethnicities with schizophrenia-spectrum disorders, and response to risperidone. METHOD: African-American (n = 38), Caucasian (n = 30), or Hispanic (n = 37) youths started on risperidone were eligible. Child Behavior Checklist (CBCL) total, internalizing, and externalizing scores were evaluated at baseline, 90 days, 1 year, and 2 year intervals. RESULTS: At baseline, Hispanic patients had lower CBCL externalizing scores than African-Americans or Caucasians. African-Americans showed significant differences in CBCL total, internalizing, and externalizing scores at 90 days compared to baseline. Hispanics showed improvement in CBCL internalizing scores over the 2 year period. No significant improvements were observed in Caucasians. African-American patients had significantly lower CBCL total at 90 days compared to Hispanic patients. No significant difference existed in 2 year hospitalization rates between groups. CONCLUSIONS: These findings suggest that ethnicity may play a role in symptom presentation and treatment response to risperidone for children and adolescents with schizophrenia-spectrum disorders. Future studies in children and adolescents are necessary to examine ethnospecific differences in antipsychotic use and treatment response.
Adolescent↗
Diagnoses and antipsychotic treatment among youths in a public mental health system.
BACKGROUND: The use of antipsychotics, namely newer atypical agents, has increased significantly in children and adolescents. It is important to examine diagnoses associated with antipsychotic treatment in youths. OBJECTIVE: To evaluate trends in psychiatric diagnoses of children and adolescents in a public mental health system who were prescribed antipsychotics. METHODS: Children and adolescents, up to the age of 19 years, who were prescribed an antipsychotic between January 1998 and December 2001 were identified using the Texas Medicaid Vendor Drug database. Patient identification numbers were then cross-linked to the Client Assignment and Registration database of the Texas Department of Mental Health and Mental Retardation to extract diagnostic data. RESULTS: Disruptive behavioral disorders accounted for the highest percentage (35%) of diagnoses associated with children and adolescents receiving antipsychotic treatment and mental healthcare services. Depressive disorders were the second most common diagnosis (18%), and bipolar disorders accounted for roughly 12% of all diagnoses. Approximately 3% of children and adolescents did not have a psychiatric diagnosis. The percentage of youths with comorbid psychiatric diagnoses decreased over time. CONCLUSIONS: Although disruptive behavioral disorders accounted for a large percentage of antipsychotic use in this population, these findings suggest that antipsychotics are being used to treat other psychiatric diagnoses, for which limited supporting data exist. Future research in children and adolescents should aim to provide needed efficacy and safety data of antipsychotics across the spectrum of neuropsychiatric disorders.
Adolescent↗
An economic comparison of risperidone and olanzapine use within an integrated managed mental health program.
This study assessed differences in total mental health care costs for 1 year following initiation of risperidone or olanzapine in individuals within NorthSTAR, an integrated managed mental health pilot project. A retrospective database analysis of individuals with schizophrenia or schizoaffective disorder and newly started on either agent was conducted. Antipsychotic medication costs were significantly lower for individuals prescribed risperidone than olanzapine (1763 dollars versus 2582 dollars; p<0.001). Individuals prescribed risperidone had lower (but not significant) expenditures for mental health services (4714 dollars versus 5077 dollars; p=0.792), as well as total mental health care costs (7407 dollars versus 9011 dollars; p=0.255).
Antipsychotic Agents↗
The Texas Children's Medication Algorithm Project: revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder.
OBJECTIVE: In 1998, the Texas Department of Mental Health and Mental Retardation developed algorithms for medication treatment of attention-deficit/hyperactivity disorder (ADHD). Advances in the psychopharmacology of ADHD and results of a feasibility study of algorithm use in community mental health centers caused the algorithm to be modified and updated. METHOD: We convened a consensus conference of academic clinicians and researchers, practicing clinicians, administrators, consumers, and families to revise the algorithms for the pharmacotherapy of ADHD itself as well as ADHD with specific comorbid disorders. New research was reviewed by national experts, and rationales were provided for proposed changes and additions to the algorithms. The changes to the algorithms were discussed and approved both by the national experts and experienced clinicians from the Texas public mental health system. RESULTS: The panel developed consensually agreed-upon algorithms for ADHD with and without comorbid disorders. The major changes included elimination of pemoline as a treatment option, adding atomoxetine to the algorithm, and refining guidelines for treating ADHD with comorbid depression, aggressive behaviors, and tic disorders. CONCLUSIONS: Medication algorithms for ADHD can be modified to keep abreast of developments in the field. Although these evidence- and consensus-based treatment recommendations may be a useful approach to guide the treatment of ADHD in children, additional research is needed to determine how these algorithms can be used to maximally benefit child outcomes.
Adrenergic Uptake Inhibitors↗
Physician specialty associated with antipsychotic prescribing for youths in the Texas Medicaid program.
BACKGROUND/OBJECTIVE: The use of antipsychotics in children and adolescents in the Texas Medicaid program has increased with the introduction of newer atypical antipsychotics. The purpose of this study was to examine physician specialty associated with antipsychotic prescribing from 1996 to 2001. METHODS: All antipsychotic prescription claims records for children and adolescents younger than the age of 20 years from 1996 to 2001 were extracted from the Texas Medicaid Drug Vendor prescription database. Physician specialty associated with youths receiving all, atypical, and conventional antipsychotic prescriptions was examined for time trends. Physician specialty categories included psychiatry, primary care, neurology, other, and unspecified. RESULTS: Psychiatrists accounted for more than 80% of youths receiving antipsychotic prescriptions from 1996 to 2001. The proportion of youths receiving antipsychotic prescriptions from primary care physicians remained fairly steady over the course of time (1996: 19%; 2001: 16%). The number of youths prescribed conventional antipsychotics decreased in all specialty groups, whereas the number prescribed atypical antipsychotic prescriptions increased dramatically. CONCLUSIONS: Although the majority of children and adolescents in the Texas Medicaid program were prescribed antipsychotics by psychiatrists and child and adolescent psychiatrists, youths may often receive treatment within the primary care setting. Future research is necessary to evaluate patient outcomes associated with antipsychotic treatment across different treatment settings.
Adolescent↗
An empirical analysis of cost outcomes of the Texas Medication Algorithm Project.
OBJECTIVE: Disease management systems that incorporate medication algorithms have been proposed as cost-effective means to offer optimal treatment for patients with severe and chronic mental illnesses. The Texas Medication Algorithm Project was designed to compare health care costs and clinical outcomes between patients who received algorithm-guided medication management or usual care in 19 public mental health clinics. METHODS: This longitudinal cohort study for patients with major depression (N=350), bipolar disorder (N=267), and schizophrenia (N=309) applied a multi-part declining-effects cost model. Outcomes were assessed by the Inventory of Depressive Symptomatology and the Brief Psychiatric Rating Scale. RESULTS: Compared with patients in usual care, patients in algorithm-based care incurred higher medication costs and had more frequent physician visits, although these differences often became smaller with time. For major depression, algorithm-based care achieved better outcomes sustainable with time but at higher agency and non-agency costs (mixed cost-effective). For bipolar disorder, patients in algorithm-based management achieved better outcomes at lower agency costs (cost-effective). For schizophrenia, patients in algorithm-based care achieved better outcomes that diminished with time, with no detectable difference in health care costs (cost-effective). CONCLUSIONS: Cost outcomes of algorithm-based care and usual care varied by disorder and over time. For bipolar disorder and schizophrenia, algorithm-based care improved outcomes without higher costs for health care services. For major depression, substantively better and sustained outcomes were obtained but at greater costs.
Algorithms↗
Comparison of self-report and clinician ratings on two inventories of depressive symptomatology.
OBJECTIVE: This study evaluated the concordance between the self-report and the clinician-rated versions of the Inventory of Depressive Symptomatology (IDS-30) and between the two versions of the briefer 16-item Quick Inventory of Depressive Symptomatology (QIDS-16). METHODS: Data were gathered for 544 adult outpatients with psychotic (N = 106) or nonpsychotic (N = 438) major depressive disorder at 14 public sector mental health clinics in the Texas Medication Algorithm Project. Data for the QIDS-16 were extracted from the IDS-30. Baseline scores and scores from the final study visit at or before month 12 were analyzed. The clinician-rated and the self-report versions of each scale were compared in their identification of response to treatment and remission. RESULTS: The average baseline IDS-SR-30 total score was 2.2 points higher (indicating greater severity) than the IDS-C-30 score; the average QIDS-SR-16 total score was only .3 points higher than the QIDS-C-16 score. The IDS-SR-30 and the IDS-C-30, as well as the QIDS-C-16 and QIDS-SR-16, agreed substantially in classifying response and remission for patients, regardless of whether the patients had psychotic features. None of a large number of clinical and demographic features accounted for differences between the QIDS-SR-16 and QIDS-C-16 total scores. CONCLUSIONS: Either the IDS-30 or the QIDS-16 self-report adequately assesses depressive symptom severity among public-sector outpatients with major depressive disorder. The briefer QIDS-16 may be preferred to save time and cost.
Adult↗
The state of science and research in clinical pharmacy.
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Education, Pharmacy↗
Implementation of the Texas Medication Algorithm Project patient and family education program.
OBJECTIVE: This article describes the implementation and utilization of the patient and family education program (PFEP) component of the Texas Medication Algorithm Project (TMAP). The extent of participation, types of psychoeducation received, and predictors of receiving at least a minimum level of education are presented. METHOD: TMAP included medication guidelines, a dedicated clinical coordinator, standardized assessments of symptoms and side effects, uniform documentation, and a PFEP. The PFEP includes phased, multimodal, disorder-specific educational materials for patients and families. Participants were adult outpatients of 1 of 7 community mental health centers in Texas that were implementing the TMAP disease management package. Patients had DSM-IV clinical diagnoses of major depressive disorder, with or without psychotic features; bipolar I disorder or schizoaffective disorder, bipolar type; or schizophrenia or schizoaffective disorder. Assessments were administered by independent research coordinators. Study data were collected between March 1998 and March 2000, and patients participated for at least 1 year. RESULTS: Of the 487 participants, nearly all (95.1%) had at least 1 educational encounter, but only 53.6% of participants met criteria for "minimum exposure" to individual education interventions. Furthermore, only 31.0% participated in group education, and 42.5% had a family member involved in at least 1 encounter. Participants with schizophrenia were less involved in the PFEP across multiple indicators of utilization. Diagnosis, intensity of symptoms, age, and receipt of public assistance were related to the likelihood of exposure to minimum levels of individual education. CONCLUSION: Despite adequate resources and infrastructure to provide PFEP, utilization was less than anticipated. Although implementation guidelines were uniform across diagnoses, participants with schizophrenia experienced less exposure to psychoeducation. Recommendations for improving program implementation and modification of materials are discussed.
Adult↗
Does provider adherence to a treatment guideline change clinical outcomes for patients with bipolar disorder? Results from the Texas Medication Algorithm Project.
BACKGROUND: Despite increasing adoption of clinical practice guidelines in psychiatry, there is little measurement of provider implementation of these recommendations, and the resulting impact on clinical outcomes. The current study describes one effort to measure these relationships in a cohort of public sector out-patients with bipolar disorder. METHOD: Participants were enrolled in the algorithm intervention of the Texas Medication Algorithm Project (TMAP). Study methods and the adherence scoring algorithm have been described elsewhere. The current paper addresses the relationships between patient characteristics, provider experience with the algorithm, provider adherence, and clinical outcomes. Measurement of provider adherence includes evaluation of visit frequency, medication choice and dosing, and response to patient symptoms. An exploratory composite 'adherence by visit' score was developed for these analyses. RESULTS: A total of 1948 visits from 141 subjects were evaluated, and utilized a two-stage declining effects model. Providers with more experience using the algorithm tended to adhere less to treatment recommendations. Few patient factors significantly impacted provider adherence. Increased adherence to algorithm recommendations was associated with larger decreases in overall psychiatric symptoms and depressive symptoms over time, but did not impact either immediate or long-term reductions in manic symptoms. CONCLUSIONS: Greater provider adherence to treatment guideline recommendations was associated with greater reductions in depressive symptoms and overall psychiatric symptoms over time. Additional research is needed to refine measurement and to further clarify these relationships.
Adolescent↗
Brief psychiatric rating scale expanded version: How do new items affect factor structure?
Our goal was to suggest a factor structure for the Brief Psychiatric Rating Scale Expanded Version (BPRS-E) based upon a large and diverse sample and to determine which of the new items improved the factors derived from the 18-item version of the scale that have been used in clinical research for decades. We investigated the consistency of our proposed model over time and across demographic groups. As part of the Texas Medication Algorithm Project, the BPRS-E was administered to a total of 1440 psychiatric outpatients in three different diagnostic groups on multiple occasions. The sample was randomly split so that exploratory factor analysis could be done with the first half, and the model could be confirmed on the second half. A four-factor structure including factors assessing depression/anxiety, psychosis, negative symptoms, and activation was found. For each factor, we specify items in the expanded version that added to the breadth of the commonly used clinical factors while improving or maintaining goodness of fit and reliability. The final model proposed was consistent over time and across diagnosis, phase of illness, age, gender, ethnicity, and level of education. The BPRS-E has a stable four-factor structure, making it useful as a clinical outcome measure.
Adult↗
A psychoeducational program for children with ADHD or depression and their families: results from the CMAP feasibility study.
For children and adolescents with behavioral and emotional disorders and their families, education about their disorders and the treatments is an essential component of a comprehensive approach to their care. Education can encourage active participation in treatment, enhance adherence to treatment regimens, and provide patients and families with important coping skills. Thus, the Children's Medication Algorithm Project (CMAP) incorporated a psychoeducational program into the medication algorithm created to improve treatment of children with ADHD and/or depression in the Texas public mental health sector. This article describes the process by which a comprehensive educational program was developed in partnership with parents and advocates. The final program is described, as well as a pilot study to examine the feasibility of implementation in four community clinics.
Adaptation, Psychological↗
Duloxetine hydrochloride: a new dual-acting medication for the treatment of major depressive disorder.
BACKGROUND: Duloxetine hydrochloride has recently been approved by the US Food and Drug Administration for the treatment of major depressive disorder (MDD). Duloxetine is a potent inhibitor of serotonin and norepinephrine reuptake, with weak effects on dopamine reuptake. OBJECTIVE: This article reviews the literature on duloxetine with regard to its pharmacodynamics, pharmacokinetics, clinical efficacy, and tolerability. METHODS: A comprehensive search of MEDLINE was performed using the terms duloxetine, Cymbalta, and major depressive disorder, with no restriction on year. The Eli Lilly and Company clinical trial registry, and abstracts and posters from recent American Psychiatric Association meetings were also reviewed. RESULTS: Duloxetine exhibits linear, dose-dependent pharmacokinetics across the approved oral dosage range of 40 to 60 mg/d. No dose adjustment appears to be needed based on age. Duloxetine has shown efficacy in reducing depressive symptoms compared with placebo, and duloxetine recipients have shown significant improvements in global functioning compared with placebo (both, P < 0.05). Response and remission rates have been comparable to or greater than those seen with fluoxetine or paroxetine. Duloxetine is generally well tolerated, with nausea, dry mouth, and fatigue being the most common treatment-emergent adverse effects. Cardiovascular adverse effects do not appear to result in sustained blood pressure elevations, QTc-interval prolongation, or other electrocardiographic changes. CONCLUSIONS: Based on the available evidence, duloxetine is a well-tolerated and effective treatment for MDD in adults. Randomized head-to-head comparisons against established antidepressants are needed to determine the relative safety and efficacy of duloxetine.
Adult↗
Unanswered questions regarding atypical antipsychotic use in aggressive children and adolescents.
The aim of this paper was to discuss the arguments for and against the use of atypical antipsychotics in children and adolescents with aggression, and provide recommendations for future research. A MEDLINE search (1985-2004) was performed to identify key literature. Search terms included, but were not limited to, clozapine, olanzapine, quetiapine, risperidone, ziprasidone, children, and adolescents. The search was limited to English-language literature and randomized controlled trials. The use of atypical antipsychotics in children and adolescents has increased significantly over the past few years. Atypical antipsychotics are associated with a more favorable side-effect profile, and growing evidence supports their efficacy for aggression in this population. However, the long-term effects of these agents are unknown. No head-to-head evidence exists to suggest whether pharmacological or nonpharmacological treatments are superior for managing aggression associated with childhood and adolescent psychiatric and behavioral conditions. Future research of atypical antipsychotics in children and adolescents needs to evaluate not only the efficacy but also the effectiveness. Examination of treatment mediators and moderators may help to optimize treatment regimens and improve patient outcomes. Finally, effective interventions require the development and implementation of evidence-based treatment strategies using a multidisciplinary approach.
Adolescent↗
Trends in the use of typical and atypical antipsychotics in children and adolescents.
OBJECTIVE: To estimate prevalence rates of antipsychotic use in children and adolescents from 1996 to 2001 in three state Medicaid programs (midwestern [MM], southern [SM], and western [WM]) and one private managed care organization (MCO). METHOD: Prescription claims were used to evaluate antipsychotic prevalence, defined as the number of children and adolescents up to the age of 19 years with at least one prescription claim for an antipsychotic per 1,000 enrolled youths. RESULTS: From 1996 to 2001, the prevalence of total antipsychotic use increased in each program (MM: 4.7 to 14.3 per 1,000; SM: 6.3 to 15.5; WM: 4.5 to 6.9; and MCO: 1.5 to 3.4). Typical antipsychotic use decreased (MM: 3.7 to 2.0 per 1,000; SM: 4.6 to 1.5; WM: 4.4 to 1.3; and MCO: 1.2 to 0.9), while atypical antipsychotic use dramatically increased (MM: 1.4 to 13.1 per 1,000; SM: 2.5 to 14.9; WM: 0.3 to 6.2; and MCO: 0.4 to 2.7). CONCLUSIONS: The increased prevalence of antipsychotic use in children and adolescents from 1996 to 2001 was attributed to increased use of atypical antipsychotics. Given the limited data with atypical antipsychotics in youths, this emphasizes the need for additional studies of these agents and other treatment modalities in this population.
Adolescent↗
Assessment of adherence measures with different stimulants among children and adolescents.
STUDY OBJECTIVE: To examine adherence measures with different stimulants in children and adolescents. DESIGN: Retrospective analysis. DATA SOURCE: Texas Medicaid prescription claims database. PATIENTS: A total of 9549 patients aged 5-18 years with attention-deficit-hyperactivity disorder. MEASUREMENTS AND MAIN RESULTS: Paid prescription claims for newly started stimulants during the 2001-2002 school year were extracted from a database; 28,344 prescriptions (9549 patients) were available for analysis. Adherence was evaluated based on the drug therapy prescribed (i.e., mixed amphetamine salts, immediate-release methylphenidate, and extended-release methylphenidate-OROS [oral-osmotic formulation]) and the age and sex of the patient. Adherence measures were persistence and medication possession ratio (MPR). Persistence was higher for extended-release methylphenidate-OROS (0.50 +/- 0.33) than for mixed amphetamine salts (0.42 +/- 0.29) or immediate-release methylphenidate (0.37 +/- 0.26; p < 0.001). The MPR was also higher for extended-release methylphenidate-OROS (0.76 +/- 0.37) than for mixed amphetamine salts (0.73 +/- 0.37) or immediate-release methylphenidate (0.69 +/- 0.37; p < 0.001). Patients aged 5-9 years had equal or better persistence and MPR than those aged 10-14 and 15-18 years (p < 0.001). No sex-related differences in adherence were observed. CONCLUSION: Adherence measures in our study were low. Although they were significantly better for extended-release methylphenidate-OROS than the other stimulants, the clinical significance of these differences are unclear. Further research should be conducted regarding pharmaceutical products, administration methods, and clinical interventions that may enhance adherence.
Adolescent↗