Trauma-Informed Medical Care: Patient Response to a Primary Care Provider Communication Training.

Trauma exposure predicts mental disorders and health outcomes; yet there is little training of primary care providers about trauma's effects, and how to better interact with trauma survivors. This study adapted a theory-based approach to working with trauma survivors, Risking Connection, into a 6-hour CME course, Trauma-Informed Medical Care (TI-Med), to evaluate its feasibility and preliminary efficacy. We randomized four primary care sites to training or wait-list conditions; PCPs at wait-list sites were trained after reassessment.

Comparison of Site-Based Versus Central Ratings in a Study of Generalized Anxiety Disorder.

Lack of standardization across sites and raters, poor interrater reliability, and possible scoring bias affecting the primary outcome measure contribute to a high failure rate in anxiety trials. Remote centralized raters who are blinded to protocol inclusion and exclusion criteria as well as visit number may standardize assessments across raters and eliminate scoring bias, decreasing placebo response and thereby increasing signal detection. The purpose of the primary study was to test the safety and efficacy of an anxiolytic in a double-blind, placebo-controlled (no active comparator), multicenter trial.

Trauma-informed medical care: CME communication training for primary care providers.

Background And Objectives: Trauma exposure predicts mental disorders, medical morbidity, and health care costs. Yet trauma-related impacts have not received sufficient attention in primary care provider (PCP) training programs. This study adapted a theory-based approach to working with trauma survivors, Risking Connection, into a 6-hour CME course, Trauma-Informed Medical Care (TI-Med), and evaluated its efficacy.

A 6-week randomized, double-blind, placebo-controlled, comparator referenced trial of vabicaserin in acute schizophrenia.

Unlabelled: Vabicaserin, a potent 5-HT2C receptor agonist, decreases nucleus accumbens extracellular dopamine levels in rats, without affecting striatal dopamine, indicating mesolimbic selectivity. This is the first study of efficacy, safety and tolerability of vabicaserin in adults with acute schizophrenia. Three hundred fourteen hospitalized subjects were randomized to: Vabicaserin 200 or 400 mg/day, olanzapine 15 mg/day or placebo.

Weight effects associated with antipsychotics: a comprehensive database analysis.

Background: Available data on atypical antipsychotic-induced weight gain are limited by a number of methodological factors. The objective of this report is to evaluate short-term (N=1742) and long-term (N=1649) weight effects in patients receiving standard doses of amisulpride, haloperidol, olanzapine, risperidone, ziprasidone, and placebo based on 21 randomized, placebo-controlled, parallel-group studies from an integrated clinical trial database.

Method: Analyses of the integrated ziprasidone schizophrenia trials database were performed to estimate the weighted average of weight change and the percentage of subjects experiencing weight gain (or weight loss) across studies for each agent studied, based on fixed- and random-effects models.

Microextraction of volatile organic compounds using the inside needle capillary adsorption trap (INCAT) device.

A novel method of solventless extraction has been developed based on a combination of solid phase micro extraction and purge and trap methods. In this technique, a hollow needle with either a short length of GC capillary column placed inside it, or an internal coating of carbon, is used as the preconcentration device. Sampling may be performed on ambient air, on solution, or the solution headspace, by passing the gas or liquid through the device either actively with a syringe, or passively via diffusion.

Ziprasidone in treatment-resistant schizophrenia: a 52-week, open-label continuation study.

Objective: To evaluate the efficacy, safety, and tolerability of long-term ziprasidone therapy in treatment-resistant schizophrenia.

Method: This prospective, 1-year, open-label study of ziprasidone (40-160 mg/day) was conducted in subjects who had participated in a previous randomized 12-week comparison of ziprasi-done and chlorpromazine in treatment-resistant schizophrenia (DSM-III-R criteria). The clinical response of 62 subjects was evaluated (32 subjects had been on ziprasidone treatment and 30 had been on chlorpromazine treatment prior to enrollment in the continuation study).

Clinical evaluation of ganaxolone in pediatric and adolescent patients with refractory epilepsy.

Purpose: A pilot study of the safety, tolerability, dose range and potential efficacy of ganaxolone for the treatment of refractory epilepsy in pediatric and adolescent subjects.

Methods: We report the results of a nonrandomized, nonblinded, open-label, dose-escalation trial of ganaxolone in pediatric subjects (5-15 years) suffering from refractory epilepsy. Subjects received an oral suspension of ganaxolone in a 1:1 complex with beta-cyclodextrin in a dose escalation (1 mg/kg, b.

Ganaxolone.

Ganaxolone (3alpha-hydroxy-3beta-methyl-5alpha-pregnan-20-one) (GNX) is the 3beta-methylated synthetic analog of allopregnanolone; it belongs to a class of compounds referred to as neurosteroids. GNX is an allosteric modulator of GABA(A) receptors acting through binding sites which are distinct from the benzodiazepine binding site. It has activity in a broad range of animal models of epilepsy.

Efficacy and tolerability of ziprasidone in patients with treatment-resistant schizophrenia.

This multicentre, parallel-group study compared the efficacy and tolerability of ziprasidone and chlorpromazine in treatment-resistant schizophrenia (at least three treatment periods of at least 6 weeks each with two or more antipsychotic agents during the past 5 years without significant response) that was unresponsive to 6 weeks of open-label haloperidol ( View Article and Find Full Text PDF

Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial.

Objective: The study evaluated the efficacy and tolerability of ziprasidone, compared with placebo, in the treatment of adult patients with acute bipolar mania.

Method: Patients with a primary DSM-IV diagnosis of bipolar I disorder and a current manic or mixed episode (confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Patient Edition) (N=210) were randomly assigned in a 2:1 ratio to 3 weeks of double-blind treatment with ziprasidone (40-80 mg twice daily) or placebo. Efficacy was assessed with the Schedule for Affective Disorders and Schizophrenia, Change Version (which contains the Mania Rating Scale), Positive and Negative Syndrome Scale, Clinical Global Impression (CGI) severity scale, CGI improvement scale, and Global Assessment of Functioning Scale.

Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the food and drug administration summary basis of approval reports.

The assumption that the design of an antidepressant clinical trial affects the outcome of that trial is based on sparse data. We sought to examine if the dosing schedule, either a fixed dose or a flexible dose type, in an antidepressant clinical trial affects the frequency with which antidepressants show statistical superiority over placebo. Randomized, placebo-controlled clinical trials of nine antidepressants approved by the Food and Drug Administration between 1985 and 2000 were reviewed.

Relationship between posttraumatic stress disorder characteristics of Holocaust survivors and their adult offspring.

Objective: There is controversy regarding the long-lasting effects of the Holocaust on the adult children of Holocaust survivors. In the present study the authors examined the relationship between posttraumatic stress disorder (PTSD) characteristics of Holocaust survivors and their adult children to determine whether differences in symptom severity or diagnostic status of parents would be associated with similar characteristics in their adult children.

Method: Holocaust survivors (N = 22) and their offspring (N = 22) were interviewed with several instruments to assess lifetime trauma history, effect of trauma on one's life, level of intrusive and avoidance symptoms in response to reminders of the Holocaust, current and lifetime PTSD, and current and lifetime axis I psychiatric disorder other than PTSD.

Alexithymia in Holocaust survivors with and without PTSD.

Alexithymia was measured in non-treatment seeking, community-dwelling Holocaust survivors using the Toronto Alexithymia Scale-Twenty Item Version (TAS-20). Scores of survivors with (n = 30) and without (n = 26) posttraumatic stress disorder (PTSD) were compared, and associations among alexithymia, severity of trauma, and severity of PTSD symptoms were determined. Survivors with PTSD had significantly higher scores on the TAS-20 compared to survivors without PTSD.

Prolactin response to low-dose dexamethasone challenge in combat-exposed veterans with and without posttraumatic stress disorder and normal controls.

The prolactin and cortisol responses to dexamethasone (0.5 mg) were studied in combat veterans with (n = 18) and without (n = 12) posttraumatic stress disorder (PTSD) and normal controls (n = 18). Both veteran groups demonstrated greater prolactin suppression than the normals.

Dissociation in aging Holocaust survivors.

Objective: This study explored relationships among dissociation, trauma, and posttraumatic stress disorder (PTSD) in elderly Holocaust survivors with and without PTSD and in a demographically comparable group of nontraumatized subjects.

Method: Holocaust survivors with PTSD (N = 35) and without PTSD (N = 25) who had been recruited from the community and a comparison group (N = 16) were studied. Dissociation was evaluated with the Dissociative Experiences Scale.

Impact of cumulative lifetime trauma and recent stress on current posttraumatic stress disorder symptoms in holocaust survivors.

Objective: The purpose of this study was to examine the relationships among cumulative lifetime trauma, recent stressful events, and presence and severity of current posttraumatic stress disorder (PTSD) symptoms in Holocaust survivors and nonexposed comparison subjects.

Method: Lifetime trauma, recent stressful events, and presence and severity of PTSD were assessed in Holocaust survivors (N=72) and comparison subjects ( N=19).

Results: Survivors with PTSD (N =40) reported significantly greater cumulative trauma and recent stress than survivors without PTSD (N=32) and comparison subjects.

Low urinary cortisol excretion in Holocaust survivors with posttraumatic stress disorder.

Objective: The authors' objective was to compare the urinary cortisol excretion of Holocaust survivors with posttraumatic stress disorder (PTSD) (N = 22) to that of Holocaust survivors without PTSD (N = 25) and comparison subjects not exposed to the Holocaust (N = 15).

Method: Twenty-four-hour urine samples were collected, and the following day, subjects were evaluated for the presence and severity of past and current PTSD and other psychiatric conditions.

Results: Holocaust survivors with PTSD showed significantly lower mean 24-hour urinary cortisol excretion than the two groups of subjects without PTSD.

Dose-response changes in plasma cortisol and lymphocyte glucocorticoid receptors following dexamethasone administration in combat veterans with and without posttraumatic stress disorder.

Background: Our previous studies have suggested that combat veterans with posttraumatic stress disorder (PTSD) have alterations in hypothalamic-pituitary-adrenal axis functioning that are different from the well-documented biological changes observed in major depressive disorder and following exposure to stress.

Methods: In the present study, we examined cortisol and lymphocyte glucocorticoid receptor number before and after the administration of 0.50 and 0.

Psychological dimensions of depression in borderline personality disorder.

Objective: The authors' goal was to test empirically a commonly held assumption that the depression in borderline personality disorder is primarily anaclitic.

Method: The Depressive Experiences Questionnaire and the Hamilton Rating Scale for Depression were administered to 26 patients with borderline personality disorder (16 of whom were depressed) and 12 depressed patients without borderline personality disorder.

Results: Patients with borderline personality disorder showed more self-criticism but did not endorse more anaclitic items than depressed patients without borderline personality disorder.

Depressive features in Holocaust survivors with post-traumatic stress disorder.

The present study was designed to explore several aspects of depressive phenomenology, including current symptoms, dependency (anaclitic) and self-criticism (introjective) themes, and issues of self-efficacy, in Holocaust survivors with and without posttraumatic stress disorder (PTSD). The Depressive Subscale of the Symptom Checklist-90 (SCL-90) and the Depressive Experiences Questionnaire (DEQ) were administered to 23 Holocaust survivors and 18 demographically-matched controls. Holocaust survivors with PTSD scored significantly higher on the SCL-90 depression scale, and portrayed more self-criticism on the DEQ, than Holocaust survivors without PTSD and demographically-matched non-exposed subjects.

Glucocorticoid receptor number and cortisol excretion in mood, anxiety, and psychotic disorders.

In the present study, we measured cytosolic lymphocyte glucocorticoid receptor and 24-hour urinary cortisol excretion in patients with major depressive disorder, bipolar mania, posttraumatic stress disorder, panic disorder, and schizophrenia. Patients with major depression had the smallest, and posttraumatic stress disordered patients the largest, mean number of glucocorticoid receptors per cell compared to patients in the other groups. Bipolar manic and panic patients did not differ from each other in regard to the number of lymphocyte glucocorticoid receptors.

Psychoneuroendocrine assessment of posttraumatic stress disorder: current progress and new directions.

1. Studies in our laboratory have used the psychoendocrine strategy to explore differences in basal hormone levels between patients with posttraumatic stress disorder (PTSD) and other groups. This approach has allowed us to explore the relationship between hormone levels and specific psychological and biological processes which appear to develop following exposure to extreme trauma.