The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder.

The Depression Inventory Development project is an initiative of the International Society for CNS Drug Development whose goal is to develop a comprehensive and psychometrically sound measurement tool to be utilized as a primary endpoint in clinical trials for major depressive disorder. Using an iterative process between field testing and psychometric analysis and drawing upon expertise of international researchers in depression, the Depression Inventory Development team has established an empirically driven and collaborative protocol for the creation of items to assess symptoms in major depressive disorder. Depression-relevant symptom clusters were identified based on expert clinical and patient input.

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.

Transcultural Adaptation of GRID Hamilton Rating Scale For Depression (GRID-HAMD) to Brazilian Portuguese and Evaluation of the Impact of Training Upon Inter-Rater Reliability.

Unlabelled: GRID-HAMD is a semi-structured interview guide developed to overcome flaws in HAM-D, and has been incorporated into an increasing number of studies.

Objectives: Carry out the transcultural adaptation of GRID-HAMD into the Brazilian Portuguese language, evaluate the inter-rater reliability of this instrument and the training impact upon this measure, and verify the raters' opinions of said instrument.

Methods: The transcultural adaptation was conducted by appropriate methodology.

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.

Attitudes toward borderline personality disorder: a survey of 706 mental health clinicians.

Objective: We sought to determine attitudes toward patients with borderline personality disorder (BPD) among mental health clinicians at nine academic centers in the United States.

Methods: A self-report questionnaire was distributed to 706 mental health clinicians, including psychiatrists, psychiatry residents, social workers, nurses, and psychologists.

Results: The study showed that most clinicians consider BPD a valid diagnosis, although nearly half reported that they preferred to avoid these patients.

The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review.

Background: Depression, anxiety and somatization are the most common mental disorders in primary care as well as medical specialty populations; each is present in at least 5-10% of patients and frequently comorbid with one another. An efficient means for measuring and monitoring all three conditions would be desirable.

Methods: Evidence regarding the psychometric and pragmatic characteristics of the Patient Health Questionnaire (PHQ)-9 depression, generalized anxiety disorder (GAD)-7 anxiety and PHQ-15 somatic symptom scales are synthesized from two sources: (1) four multisite cross-sectional studies (three conducted in primary care and one in obstetric-gynecology practices) comprising 9740 patients, and (2) key studies from the literature that have studied these scales.

Trauma exposure and posttraumatic stress disorder in primary care patients: cross-sectional criterion standard study.

Objective: Posttraumatic stress disorder (PTSD) is one of the most common but least recognized anxiety disorders in primary care. This study aimed to describe the association of PTSD and trauma exposure with somatic symptoms, psychiatric comorbidity, functional impairment, and the actual treatment of PTSD in primary care.

Method: This cross-sectional criterion standard study included 965 consecutive primary care patients from 15 civilian primary care clinics in the United States.

Site versus centralized raters in a clinical depression trial: impact on patient selection and placebo response.

The use of centralized raters who are remotely linked to sites and interview patients via videoconferencing or teleconferencing has been suggested as a way to improve interrater reliability and interview quality. This study compared the effect of site-based and centralized ratings on patient selection and placebo response in subjects with major depressive disorder. Subjects in a 2-center placebo and active comparator controlled depression trial were interviewed twice at each of 3 time points: baseline, 1-week postbaseline, and end point--once by the site rater and once remotely via videoconference by a centralized rater.

An ultra-brief screening scale for anxiety and depression: the PHQ-4.

Background: The most common mental disorders in both outpatient settings and the general population are depression and anxiety, which frequently coexist. Both of these disorders are associated with considerable disability.

Objective: When the disorders co-occur, the disability is even greater.

Sources of unreliability in depression ratings.

Background: Good interrater reliability is essential to minimize error variance and improve study power. Reasons why raters differ in scoring the same patient include information variance (different information obtained because of asking different questions), observation variance (the same information is obtained, but raters differ in what they notice and remember), interpretation variance (differences in the significance attached to what is observed), criterion variance (different criteria used to score items), and subject variance (true differences in the subject). We videotaped and transcribed 30 pairs of interviews to examine the most common sources of rater unreliability.

The association between anxiety and alcohol versus cannabis abuse disorders among adolescents in primary care settings.

Background: Both clinical and population-based studies show that anxiety disorders and substance misuse frequently co-occur in adults, whereas among adolescents, less examination of this association has been done. Adolescence is frequently the time of substance use initiation and its subsequent interaction with anxiety disorders has not been fully explored. It is unknown in adolescents whether anxiety is more related to alcohol abuse versus cannabis abuse.

The PHQ-8 as a measure of current depression in the general population.

Background: The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. Our objectives were to assess the PHQ-8 as a depression measure in a large, epidemiological population-based study, and to determine the comparability of depression as defined by the PHQ-8 diagnostic algorithm vs. a PHQ-8 cutpoint > or = 10.

Gastrointestinal symptoms in primary care: prevalence and association with depression and anxiety.

Objective: Results from general population studies suggest a relationship between gastrointestinal (GI) symptoms, depression, and anxiety. However, no primary care study has investigated this issue. This study investigates the prevalence of GI symptoms in primary care and their association with depression and anxiety.

Depression, anxiety and somatization in primary care: syndrome overlap and functional impairment.

Objective: To determine diagnostic overlap of depression, anxiety and somatization as well as their unique and overlapping contribution to functional impairment.

Method: Two thousand ninety-one consecutive primary care clinic patients participated in a multicenter cross-sectional survey in 15 primary care clinics in the United States (participation rate, 92%). Depression, anxiety, somatization and functional impairment were assessed using validated scales from the Patient Health Questionnaire (PHQ) (PHQ-8, eight-item depression module; GAD-7, seven-item Generalized Anxiety Disorder Scale; and PHQ-15, 15-item somatic symptom scale) and the Short-Form General Health Survey (SF-20).

The GRID-HAMD: standardization of the Hamilton Depression Rating Scale.

This report describes the GRID-Hamilton Depression Rating Scale (GRID-HAMD), an improved version of the Hamilton Depression Rating Scale that was developed through a broad-based international consensus process. The GRID-HAMD separates the frequency of the symptom from its intensity for most items, refines several problematic anchors, and integrates both a structured interview guide and consensus-derived conventions for all items. Usability was established in a small three-site sample of convenience, evaluating 29 outpatients, with most evaluators finding the scale easy to use.

Development and reliability of a structured interview guide for the Montgomery Asberg Depression Rating Scale (SIGMA).

Background: The Montgomery-Asberg Depression Rating Scale (MADRS) is often used in clinical trials to select patients and to assess treatment efficacy. The scale was originally published without suggested questions for clinicians to use in gathering the information necessary to rate the items. Structured and semi-structured interview guides have been found to improve reliability with other scales.

A comparison of face-to-face and remote assessment of inter-rater reliability on the Hamilton Depression Rating Scale via videoconferencing.

Poor inter-rater reliability (IRR) is an important methodological factor that may contribute to failed trials. The sheer number of raters at diverse sites in multicenter trials presents a formidable challenge in calibration. Videoconferencing allows for the evaluation of IRR of raters at diverse sites by enabling raters at different sites to each independently interview a common patient.

Face-to-face versus remote administration of the Montgomery-Asberg Depression Rating Scale using videoconference and telephone.

Although the use of telemedicine in psychiatry has a long history in providing clinical care to patients, its use in clinical trials research has not yet been commonly employed. Telemedicine allows for the remote assessment of study patients, which could be done by a centralized, highly calibrated, and impartial cohort of raters independent of the study site. This study examined the comparability of remote administration of the Montgomery-Asberg Depression Rating Scale (MADRS) by videoconference and by telephone to traditional face-to-face administration.

Primary care patients in psychiatric clinical trials: a pilot study using videoconferencing.

Background: While primary care physicians play a pivotal role in the treatment of depression, collaboration between primary care and psychiatry in clinical research has been limited. Primary care settings provide unique opportunities to improve the methodology of psychiatric clinical trials, by providing more generalizable and less treatment-resistant patients. We examined the feasibility of identifying, recruiting, screening and assessing primary care patients for psychiatric clinical trials using high-quality videoconferencing in a mock clinical trial.

A novel approach to rater training and certification in multinational trials.

Clinical trials are becoming increasingly international in scope. Global studies pose unique challenges in training and calibrating raters owing to language and cultural differences. Recent findings that poorly conducted interviews reduce study power, makes attention to raters' clinical skills critical.

Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection.

Background: Anxiety, although as common as depression, has received less attention and is often undetected and undertreated.

Objective: To determine the current prevalence, impairment, and comorbidity of anxiety disorders in primary care and to evaluate a brief measure for detecting these disorders.

Design: Criterion-standard study performed between November 2004 and June 2005.

A brief measure for assessing generalized anxiety disorder: the GAD-7.

Background: Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity.

Methods: A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005.