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Biomedical subjects

Madhukar Trivedi

Publications and source records attributed to Madhukar Trivedi.

16 recordsLinked to original sources
PubMed2005

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↗
PubMed2005

Quality improvement methods as applied to a multicenter effectiveness trial--STAR*D.

In multicenter clinical trials, important aspects of trial performance (e.g., the number of participants who enter the trial within the required time frame, the number of participants who remain in the trial, and/or the completeness of the outcome data collected) directly affect the extent to which the study can achieve its aims. Obtaining the maximum amount of data from the maximum number of participants at each step in the trial increases the likelihood of identifying real differences in outcome. These aspects of trial performance can, therefore, be considered intermediate performance goals of the study since success in achieving each of them is directly related to success in achieving study aims. A quality improvement system was introduced to improve efficiency and performance in the multicenter Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Four intermediate performance goals were targeted for quality improvement efforts: (1) initial enrollment of subjects, (2) collection of entry/exit primary outcome data, (3) retention of subjects to enter subsequent "levels" of the trial, and (4) collection of blood samples for genetics studies. The identification of numerical targets for these goals provides a basis for monitoring performance and for implementing attempts to improve performance, since success in achieving each goal is directly related to success in achieving the study aims. This paper describes the background, rationale, development, and potential utility of implementing a quality improvement system to improve the performance and efficiency of the trial.

Adolescent↗
PubMed2005

Assessing insomnia severity in depression: comparison of depression rating scales and sleep diaries.

Depression and sleep researchers typically assess insomnia severity differently. Whereas depression researchers usually assess insomnia with items on depression symptom inventories, sleep researchers usually assess the subjective experience of insomnia with sleep diaries. The present manuscript utilizes baseline data from 397 participants in a large multi-site chronic depression study to assess agreement between these two methodologies. The results indicate that the early, middle, and late insomnia items of the Hamilton Rating Scale for Depression (HRSD(24)) and the Inventory of Depression Symptoms - Self Report (IDS-SR(30)) are highly correlated with the weekly mean values of time to sleep onset, time awake after sleep onset, and time awake prior to the planned wake-up obtained from prospective sleep diaries. Results also reveal significant correspondence between the weekly-mean of daily sleep efficiency, an accepted measure of sleep continuity (the ratio between reported time asleep and time in bed), and the insomnia scale scores of the HRSD(24) and the IDS-SR(30) (the mean score on the three insomnia items of each depression measure). Unit increments in HRSD(24) scores for early, middle and late insomnia were associated with significant increases in unwanted minutes awake for corresponding periods on sleep diaries. Similar relationships were found for early insomnia on the IDS-SR(30) but not for middle and late insomnia. Overall, with few exceptions, findings revealed substantial agreement between the HRSD(24), IDS-SR(30) and prospective sleep diary data. The study supports the validity of the sleep items and sleep subscales of the HRSD(24) and the IDS-SR(30) as global measures of insomnia severity in depression. Conventional sleep assessment procedures can complement depression scales by providing additional information about specific aspects of sleep in depression.

Adult↗
PubMed2005

Psychotherapy and medication in the treatment of adult and geriatric depression: which monotherapy or combined treatment?

OBJECTIVE: The authors reviewed the literature with respect to the relative efficacy of medications and psychotherapy alone and in combination in the treatment of depression. DATA SOURCES AND STUDY SELECTION: Findings from empirical studies comparing medications and psychotherapy alone and in combination were synthesized and prognostic and prescriptive indices identified. We searched both MEDLINE and PsychINFO for items published from January 1980 to October 2004 using the following terms: treatment of depression, psychotherapy and depression, and pharmacotherapy and depression. Studies were selected that randomly assigned depressed patients to combined treatment versus monotherapy. DATA SYNTHESIS: Medication typically has a rapid and robust effect and can prevent symptom return so long as it is continued or maintained, but does little to reduce risk once its use is terminated. Both interpersonal psychotherapy (IPT) and cognitive-behavioral therapy (CBT) can be as effective as medications in the acute treatment of depressed outpatients. Interpersonal psychotherapy may improve interpersonal functioning, whereas CBT appears to have an enduring effect that reduces subsequent risk following treatment termination. Ongoing treatment with either IPT or CBT appears to further reduce risk. Treatment with the combination of medication and IPT or CBT retains the specific benefits of each and may enhance the probability of response over either monotherapy, especially in chronic depressions. CONCLUSION: Both medication and certain targeted psychotherapies appear to be effective in the treatment of depression. Although several prognostic indices have been identified that predict need for longer or more intensive treatment, few prescriptive indices have yet been established to select among the different treatments. Combined treatment can improve response with selected patients and enhance its breadth (IPT) or stability (CBT).

Adult↗
PubMed2004

Factors that differentiate early vs. later onset of major depression disorder.

This report explores the relationship between age of first onset of major depression and other demographic and clinical features in the first 1500 patients entering the Sequenced Treatment Alternative to Relieving Depression (STAR*D) study. Outpatients, 18-75 years of age, with nonpsychotic major depressive disorder (MDD) from either primary care or psychiatric practices constitute the population. Age of onset was defined at study intake by asking patients to estimate the age at which they experienced the onset of their first major depressive episode. This report divides the population in terms of pre-adult (before age 18) onset and adult (age 18 or later) onset. The results suggest that MDD that begins before age 18 has a distinct set of demographic (female gender) and clinical correlates (longer duration of illness; longer current episodes; more episodes; more suicidality; greater symptom severity; more psychiatric symptoms associated with Axis I comorbidity; and more sadness, irritability, agitation and atypical symptom features), and it appears associated with significant psychosocial consequences (lower educational attainment and marriage rates). Thus, pre-adulthood onset MDD is a particularly severe and chronic condition.

Adolescent↗
PubMed2004

One-year clinical outcomes of depressed public sector outpatients: a benchmark for subsequent studies.

BACKGROUND: The symptomatic outcomes of a cohort of public mental health sector depressed outpatients treated for 1 year are described to provide a benchmark for future long-term trials. Baseline moderators of outcome were evaluated. METHODS: Outpatients with nonpsychotic major depressive disorder (n = 118) scoring >/=30 on the 30-item Inventory of Depressive Symptomatology-Clinician Rating (IDS-C(30)) were treated with a medication algorithm and patient/family education package. Response and remission rates were assessed every 3 months with the IDS-C(30). Logistic regression analyses evaluated several baseline features in relation to outcome. RESULTS: While response and remission rates increased from 3 to 12 months, the 1-year last observation carried forward (LOCF) response (26.3%) and remission (11.0%) rates were not impressive (sustained response = 14.4%; sustained remission = 5.1%). Younger patients and those with full-time employment (at baseline) were more likely to respond. A shorter length of illness tended to be associated with higher response and remission rates (p <.10). Results are generalizable to public sector patients with substantial socioeconomic, general medical, and educational disadvantages who were sufficiently depressed to recommend a change in antidepressant medication. CONCLUSIONS: Response and remission rates were modest when compared with outcomes in shorter duration efficacy trials in depressed outpatients with less chronicity, fewer concurrent general medical conditions, and less treatment resistance. Results support the need for more powerful treatments and/or the better delivery of available treatments.

Adult↗
PubMed2004

The Texas medication algorithm project: clinical results for schizophrenia.

In the Texas Medication Algorithm Project (TMAP), patients were given algorithm-guided treatment (ALGO) or treatment as usual (TAU). The ALGO intervention included a clinical coordinator to assist the physicians and administer a patient and family education program. The primary comparison in the schizophrenia module of TMAP was between patients seen in clinics in which ALGO was used (n = 165) and patients seen in clinics in which no algorithms were used (n = 144). A third group of patients, seen in clinics using an algorithm for bipolar or major depressive disorder but not for schizophrenia, was also studied (n = 156). The ALGO group had modestly greater improvement in symptoms (Brief Psychiatric Rating Scale) during the first quarter of treatment. The TAU group caught up by the end of 12 months. Cognitive functions were more improved in ALGO than in TAU at 3 months, and this difference was greater at 9 months (the final cognitive assessment). In secondary comparisons of ALGO with the second TAU group, the greater improvement in cognitive functioning was again noted, but the initial symptom difference was not significant.

Adolescent↗
PubMed2004

Web-based communications and management of a multi-center clinical trial: the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project.

While efficient methods of communication are known to be essential in conducting large multicenter clinical trials, very little information is provided on actual methods that can be implemented to improve communication. An integrated technology-based communication system was developed for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project, which prospectively defines treatments that are most effective for participants with a diagnosis of a nonpsychotic major depressive disorder (MDD) who report an unsatisfactory clinical outcome to an initial and, if necessary, subsequent treatment(s). This web-based communication system is comprised of a multi-faceted study Web site, including a help desk, document sharing, a project directory and reports. In addition, automated reporting via e-mail and an online data correction mechanism are also available. The STAR*D communication system improves communication between study personnel and improves the quality of the study's data through the integration of system elements, the integration of those elements with traditional forms of communication,, by filling the gaps not addressed by those traditional methods and by reducing the staff workload burden.

Clinical Trials as Topic↗
PubMed2003

Catching up on health outcomes: the Texas Medication Algorithm Project.

OBJECTIVE: To develop a statistic measuring the impact of algorithm-driven disease management programs on outcomes for patients with chronic mental illness that allowed for treatment-as-usual controls to "catch up" to early gains of treated patients. DATA SOURCES/STUDY SETTING: Statistical power was estimated from simulated samples representing effect sizes that grew, remained constant, or declined following an initial improvement. Estimates were based on the Texas Medication Algorithm Project on adult patients (age > or = 18) with bipolar disorder (n = 267) who received care between 1998 and 2000 at 1 of 11 clinics across Texas. STUDY DESIGN: Study patients were assessed at baseline and three-month follow-up for a minimum of one year. Program tracks were assigned by clinic. DATA COLLECTION/EXTRACTION METHODS: Hierarchical linear modeling was modified to account for declining-effects. Outcomes were based on 30-item Inventory for Depression Symptomatology-Clinician Version. PRINCIPAL FINDINGS: Declining-effect analyses had significantly greater power detecting program differences than traditional growth models in constant and declining-effects cases. Bipolar patients with severe depressive symptoms in an algorithm-driven, disease management program reported fewer symptoms after three months, with treatment-as-usual controls "catching up" within one year. CONCLUSIONS: In addition to psychometric properties, data collection design, and power, investigators should consider how outcomes unfold over time when selecting an appropriate statistic to evaluate service interventions. Declining-effect analyses may be applicable to a wide range of treatment and intervention trials.

Adult↗
PubMed2003

A quality improvement process for implementing the Texas algorithm for schizophrenia in Ohio.

Medication algorithms developed in Texas are being implemented in a number of states in the United States and internationally. This report describes a quality improvement process adapted from the Texas Medication Algorithm Project that was used to implement the Texas algorithm for schizophrenia in Ohio. A total of 38 physicians were surveyed about their perceptions of barriers to implementation of the guidelines. The physicians generally thought that the schizophrenia algorithm was good, current, and applicable. Although they did not perceive barriers to its implementation, they did not seem to alter their practices to a great extent in response to the algorithm. The results of the study may guide other states in their implementation of algorithms.

Algorithms↗
PubMed2002

Optimizing treatment outcomes for patients with depression and generalized anxiety disorder.

The goal of the acute phase of pharmacotherapy of major depressive disorder or generalized anxiety disorder is remission (ie, complete resolution of symptoms) rather than simply a response (eg, at least a > or = 50% improvement in symptoms). Despite treatment, incompletely remitted patients often have persistent social and/or functional impairment, and are particularly vulnerable to relapse. To optimize outcomes, it is important to continue to adjust and refine the treatment plan until there is resolution of residual depressive symptoms and normalization of social functioning. Thereafter, prophylactic therapy is indicated to lessen the risk of recurrence and/or chronicity. Contemporary treatment options include older medications such as tricyclic antidepressants, newer compounds, such as selective serotonin reuptake inhibitors, the serotonin and norepinephrine reuptake inhibitor, venlafaxine, and a number of other medications with novel mechanisms of action. Although it has been conventional to assume that all antidepressants are equally effective, evidence from a recent pooled analysis of data from eight double-blind, randomized, controlled clinical studies suggests that venlafaxine therapy may be associated with higher remission rates.

Antidepressive Agents, Tricyclic↗
PubMed2002

Algorithms in clinical psychiatry: a stepped approach toward the path to recovery.

The use of clinical practice guidelines and treatment algorithms has become increasingly prevalent across all fields of medicine. The Texas Medication Algorithm Project has developed algorithms for major depressive disorder to facilitate clinical decision-making by providing physicians with a detailed, yet concise, summary of current clinical data on available pharmacotherapeutic interventions, together with specific treatment strategies and tactical recommendations. The goal of the algorithm is the attainment of full and sustainable remission of symptoms. Clinical experts, practitioners, and administrators, as well as patients and their families, all contributed to the formulation and implementation of the algorithm in order to ensure an optimum level of effectiveness and practicality. It is hoped that algorithm-driven pharmacotherapy of depression will increase the quality of care, leading to improved patient outcomes, reducing unnecessary practice variation, and increasing the overall cost-effectiveness of treatment intervention.

Algorithms↗
PubMedDate not supplied

A direct comparison of presenting characteristics of depressed outpatients from primary vs. specialty care settings: preliminary findings from the STAR*D clinical trial.

PURPOSE: No study has directly compared the clinical features of depression for patients entering clinical trials using identical enrollment criteria at primary care (PC) and specialty care (SC) settings. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study (http://www.star-d.org) provides a unique opportunity to provide this comparison for patients with a major depressive disorder (MDD) requiring treatment. SUBJECTS AND METHODS: We report baseline data for the first 1500 patients enrolled in this trial involving 41 clinic sites (18 PC, 23 SC). Broadly inclusive eligibility criteria required that patients have a DSM-IV diagnosis of nonpsychotic MDD, have not failed an adequate medication trial during their current episode and score>or=14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). Primary outcomes included the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) and the HAM-D17. RESULTS: Specialty care and PC patients had equivalent degrees of depressive severity (IDS-C30=35.8; HAM-D17=20.4). Specialty care patients were almost twice as likely to report a prior suicide attempt than PC patients (21% vs. 12%, P<.0001) and slightly less likely to endorse suicidal ideation in the past week (45.0% vs. 50.8%, P=.006). The only other distinguishing core symptoms were a slightly lower likelihood of PC patients endorsing depressed mood (95.2% vs. 97.7%, P=.032) or anhedonia (66.3% vs. 70.7%, P=.042, IDS-C30) and a lower likelihood of PC patients endorsing weight loss (IDS-C30). HAM-D17 results were identical. CONCLUSION: Depressive severity was not different, and symptomatic presentations did not differ substantially. Major depressive disorder is more similar than different among patients at SC and PC settings. Thus, similar clinical and research methods for screening, detecting and measuring treatment outcomes can be applied in both settings.

Ambulatory Care↗
PubMedDate not supplied

Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D).

In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STAR*D Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.

Clinical Trials as Topic↗
PubMedDate not supplied

Substance use disorder comorbidity in major depressive disorder: a confirmatory analysis of the STAR*D cohort.

The demographics and clinical features were compared between those with (29.4%) and without concurrent substance use disorder (SUD) in 2541 outpatients with major depression (MDD) enrolled in the Sequenced Treatment Alternatives to Relieve Depression study. Compared to those without SUD, MDD patients with concurrent SUD were more likely to be younger, male, divorced or never married, and at greater current suicide risk, and have an earlier age of onset of depression, greater depressive symptomatology, more previous suicide attempts, more frequent concurrent anxiety disorders, and greater functional impairment (p = 0.048 to <0.0001). They were also less likely to be Hispanic and endorse general medical comorbidities (p = 0.006 and 0.002, respectively).

Adolescent↗