THE DEPRESSION INVENTORY DEVELOPMENT SCALE: Assessment of Psychometric Properties Using Classical and Modern Measurement Theory in a CAN-BIND Trial.

The goal of the Depression Inventory Development (DID) project is to develop a comprehensive and psychometrically sound rating scale for major depressive disorder (MDD) that reflects current diagnostic criteria and conceptualizations of depression. We report here the evaluation of the current DID item bank using Classical Test Theory (CTT), Item Response Theory (IRT) and Rasch Measurement Theory (RMT). The present study was part of a larger multisite, open-label study conducted by the Canadian Biomarker Integration Network in Depression (ClinicalTrials.

Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial.

Background: Although internet-based cognitive behavior therapy (iCBT) interventions can reduce depression symptoms, large differences in their effectiveness exist.

Objective: The aim of this study was to evaluate the effectiveness of an iCBT intervention called Thrive, which was designed to enhance engagement when delivered as a fully automated, stand-alone intervention to a rural community population of adults with depression symptoms.

Methods: Using no diagnostic or treatment exclusions, 343 adults with depression symptoms were recruited from communities using an open-access website and randomized 1:1 to the Thrive intervention group or the control group.

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.

Computer-assisted cognitive behavior therapy for obsessive-compulsive disorder: a randomized trial on the impact of lay vs. professional coaching.

Background: The purpose of the study was to examine the impact of computerized cognitive behavior therapy (CBT) self-help treatment for obsessive-compulsive disorder (OCD) (BT Steps) both alone and when supported by coaching from either a lay non-therapist coach or an experienced CBT therapist.

Methods: Eighty-seven subjects with clinically significant OCD were recruited through newspaper ads and randomly assigned to receive 12 weeks of treatment with either BT Steps alone (n = 28), BT Steps with non-therapist coaching (n = 28), or BT Steps with CBT therapist coaching (n = 31). Subjects worked on BT Steps at their own pace.

Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies.

The objective of this study was to examine the safety and tolerability of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor, in a large cohort of elderly patients with major depressive disorder. Data were pooled from 8-week and 12-week, double-blind, randomized, placebo-controlled trials of duloxetine 60 mg/day (duloxetine=456; placebo=225). Discontinuation rates because of adverse events, treatment-emergent adverse events, abnormal changes in vital signs and weight, and changes in laboratory analytes were compared between treatments using a Cochran-Mantel-Haenszel test.

A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode.

Some evidence suggests that medications that modulate both serotonin and norepinephrine may be more effective than selective serotonin-reuptake inhibitors (SSRIs) in severe major depressive disorder (MDD). This prospective pragmatic trial tests this hypothesis. Patients with severe MDD were randomly assigned to either duloxetine (a serotonin and norepinephrine-reuptake inhibitor) or physicians' choice of four generic SSRIs.

Efficacy of pregabalin in preventing relapse in patients with generalized social anxiety disorder: results of a double-blind, placebo-controlled 26-week study.

The objective of this study was to evaluate the efficacy and safety of pregabalin in preventing relapse in generalized social anxiety disorder (SAD). Patients with Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) generalized SAD, who met responder criteria after 10 weeks of open-label treatment with fixed-dose pregabalin (450 mg/day; n=153), were randomly assigned to 26 weeks of double-blind treatment with pregabalin (450 mg/day) or placebo. The primary a-priori outcome of time to relapse was analyzed using the Kaplan-Meier method and the log-rank test.

Assessing onset of treatment benefit in depression and anxiety: conceptual considerations.

Objective: Methods for characterizing the onset of treatment benefit in major depressive disorder and generalized anxiety disorder have been studied for some time, yet there is no universal agreement as to the best approaches. Our purpose is to summarize the conceptual framework underlying modern methods for characterizing onset and detailed approaches for which there is consensus from the perspective of a clinician, clinical researcher, and statistician. Possible alternatives to unresolved issues are discussed.

Voice response system to measure healthcare costs: a STAR*D report.

Objective: To evaluate a telephone-operated, interactive voice response (IVR) system designed to collect use-of-care data from patients with major depression (UAC-IVR).

Study Design: Patient self-reports from repeated IVR surveys were compared with provider records for 3789 patients with major depression at 41 clinical sites participating in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial.

Methods: UAC-IVR responses were examined for consistency and compared with provider records to compute reporting biases and intraclass correlation coefficients.

A randomized, double-blind study of increasing or maintaining duloxetine dose in patients without remission of major depressive disorder after initial duloxetine therapy.

Objective: To compare efficacy of remaining on duloxetine 60 mg to increasing to 120 mg q.d. in patients without remission of major depressive disorder (MDD) after 6 weeks at 60 mg.

A comparison of initial duloxetine dosing strategies in patients with major depressive disorder.

Objective: To compare the effects of starting doses of duloxetine taken with or without food on tolerability and efficacy in patients with major depressive disorder (MDD).

Method: This double-blind, concurrent-dose-controlled, parallel-design trial contained a variable expected-duration placebo lead-in period and was conducted in adult outpatients with DSM-IV-TR-defined MDD at psychiatric outpatient sites between October 2004 and January 2006. In actuality, patients received placebo for 1 week and then were randomly assigned to duloxetine 30 mg once daily in the morning (q.

Duloxetine in practice-based clinical settings: assessing effects on the emotional and physical symptoms of depression in an open-label, multicenter study.

Objective: In placebo-controlled clinical trials, duloxetine has been shown to be effective and well-tolerated in patients with major depressive disorder (MDD). However, patients in registration trials may not be representative of patients in clinical practice. This study sought to assess the effectiveness, safety, and tolerability of duloxetine in diverse populations of outpatients with MDD.

A pilot study of an electronic, adolescent version of the quick inventory of depressive symptomatology.

Background: Adolescent depression assessments are time-intensive, often requiring separate interviews with an adolescent and a parent/ informant. In adults, a self-rated, interactive voice response (IVR) version of the Quick Inventory of Depressive Symptomatology (QIDS-IVR) has been shown to be reliable, valid, and sensitive to change. An adolescent version of the QIDS (QIDS-A-IVR) was created using speaker-independent voice recognition technology.

Telephonic Remote Evaluation of Neuropsychological Deficits (TREND): longitudinal monitoring of elderly community-dwelling volunteers using touch-tone telephones.

Use of interactive voice response (IVR) technology to monitor cognitive functioning in cognitively normal (CN), mild cognitive impairment (MCI), and mild dementia (MD) participants was examined using 107 community-dwelling participants, 65 to 88 years old. Baseline Clinical Dementia Ratings identified 36 participants as CN, 37 with MCI, and 34 as MD. Alzheimer's Disease Assessment Scale (ADAS) and Mini-Mental State Examinations were administered during clinic visits at weeks 0, 8, 16, and 24.

Assessing the onset of antidepressant-induced sexual dysfunction using interactive voice response technology.

Background: Sexual dysfunction is a symptom of major depression, as well as a common complication of treatment with many classes of antidepressants. Nonetheless, the various forms of sexual dysfunction continue to be underreported in clinical practice, despite the availability of validated scales such as the Changes in Sexual Functioning Questionnaire (CSFQ). The current study was designed to evaluate the validity of obtaining CSFQ data using interactive voice response (IVR) technology.

Anchoring perceptions of clinical change on accurate recollection of the past: memory enhanced retrospective evaluation of treatment (MERET).

Objective: To evaluate patients' self-reports of treatment efficacy with and without self-prompted memory aids regarding their clinical experiences obtained prior to treatment initiation.

Design: Double-blind, placebo-controlled trial with variable expected duration placebo lead-in and washout.

Setting: Multisite (US) randomized clinical trial.

Using daily interactive voice response assessments: to measure onset of symptom improvement with duloxetine.

Most clinical trials measure patient responses weekly, requiring patients to accurately recall and report their symptoms from the previous six days. More frequent assessments would be less susceptible to recall errors and recency effects as weekly assessments, but increased office visits burden clinicians and patients and can lead to higher attrition or non compliance. Interactive voice response (IVR) technology permits data collection at greater frequencies with minimal reporting burdens.