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Biomedical subjects

M H Trivedi

Publications and source records attributed to M H Trivedi.

At least 19 recordsLinked to original sources

Self-reported premenstrual exacerbation of depressive symptoms in patients seeking treatment for major depression.

BACKGROUND: Very little research has examined the frequency with which women with major depressive disorder experience premenstrual exacerbation (PME) of depression or the characteristics of those who report such worsening. The NIMH Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study provides a unique opportunity to evaluate PME in depressed women seeking treatment in primary care or psychiatric settings. METHOD: This report presents data from the first 1500 participants enrolled in the STAR*D study. Premenopausal women with major depressive disorder were asked if they experienced a worsening of their depressive symptoms 5-10 days prior to menses. Those reporting PME were compared with those reporting no PME with regard to sociodemographic characteristics, course of illness features, symptom presentation, general medical co-morbidity, functional impairment, and quality of life. RESULTS: Of 433 premenopausal women not taking oral contraceptives, 64% reported a premenstrual worsening of their depression. Women who reported PME had a longer duration of their current major depressive episode [30.7 (S.D. = 73.7) months versus 13.5 (S.D. = 13.2) months; p=0.001], as well as greater general medical co-morbidity. Women reporting PME were also more likely to endorse symptoms of leaden paralysis, somatic complaints, gastrointestinal complaints, and psychomotor slowing, and were less likely to endorse blunted mood reactivity. CONCLUSIONS: PME is endorsed by the majority of premenopausal women with major depressive disorder and appears to be associated with a longer duration of depressive episode. PME is a common and important clinical issue deserving of further attention in both research and practice.

Adolescent↗

Factors associated with chronic depressive episodes: a preliminary report from the STAR-D project.

OBJECTIVE: To identify baseline sociodemographic and clinical factors associated with a current chronic major depressive episode (MDE). METHOD: Outpatients with major depressive disorder enrolled in 41 US primary or psychiatric care sites were divided into two groups based on self-report of current episode length (<24 or > or =24 months). Logistic regression models were used to identify factors associated with chronicity of current depressive episode. RESULTS: About 21.2% of 1380 subjects were in current, chronic MDEs. Older age, less education, lower income, no private insurance, unemployment, greater general medical illness burden, lower physical quality of life, concurrent generalized anxiety disorder, fewer prior episodes, and history of prior suicide attempts were all associated with chronic episodes. Blacks, Hispanics, and patients receiving care in primary as opposed to psychiatric care settings exhibited greater chronicity. CONCLUSION: Chronic depressive episodes are common and are associated with greater illness burden, comorbidity, socioeconomic disadvantage, and racial/ethnic minority status.

Adult↗

The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation.

BACKGROUND: The present study provides additional data on the psychometric properties of the 30-item Inventory of Depressive Symptomatology (IDS) and of the recently developed Quick Inventory of Depressive Symptomatology (QIDS), a brief 16-item symptom severity rating scale that was derived from the longer form. Both the IDS and QIDS are available in matched clinician-rated (IDS-C30; QIDS-C16) and self-report (IDS-SR30; QIDS-SR16) formats. METHOD: The patient samples included 544 out-patients with major depressive disorder (MDD) and 402 out-patients with bipolar disorder (BD) drawn from 19 regionally and ethnicically diverse clinics as part of the Texas Medication Algorithm Project (TMAP). Psychometric analyses including sensitivity to change with treatment were conducted. RESULTS: Internal consistencies (Cronbach's alpha) ranged from 0.81 to 0.94 for all four scales (QIDS-C16, QIDS-SR16, IDS-C30 and IDS-SR30) in both MDD and BD patients. Sad mood, involvement, energy, concentration and self-outlook had the highest item-total correlations among patients with MDD and BD across all four scales. QIDS-SR16 and IDS-SR30 total scores were highly correlated among patients with MDD at exit (c = 0.83). QIDS-C16 and IDS-C30 total scores were also highly correlated among patients with MDD (c = 0.82) and patients with BD (c = 0.81). The IDS-SR30, IDS-C30, QIDS-SR16, and QIDS-C16 were equivalently sensitive to symptom change, indicating high concurrent validity for all four scales. High concurrent validity was also documented based on the SF-12 Mental Health Summary score for the population divided in quintiles based on their IDS or QIDS score. CONCLUSION: The QIDS-SR16 and QIDS-C16, as well as the longer 30-item versions, have highly acceptable psychometric properties and are treatment sensitive measures of symptom severity in depression.

Adult↗

Development and implementation of computerized clinical guidelines: barriers and solutions.

Research indicates that computerized decision support systems (CDSSs) can improve clinical performance and patient outcomes, and yet CDSSs are not in widespread use. Physician guidelines, in general, face barriers in implementation. Guidelines in a computerized format can overcome some of the barriers to conventional text-form guidelines; however, computerized programs have novel aspects that have to be considered, aspects such as technical problems/support and user interface issues that can act as barriers. Though the literature points out that human, organizational, and technical issues can act as barriers in the implementation of CDSSs, studies clearly indicate that there are methods that can overcome these barriers and improve CDSS acceptance and use. These methods come from lessons learned from a variety of CDSS implementation ventures. Notably, most of the methods that improve acceptance and use of a CDSS require feedback and involvement of end-users. Measuring and addressing physician or user attitudes toward the computerized support system has been shown to be important in the successful implementation of a CDSS. This article discusses: 1) the barriers of implementation of guidelines in general and of CDSSs; 2) the importance of the physician's role in development, implementation, and adherence; 3) methods that can improve CDSS acceptance and use; and 4) the types of tools needed to obtain end-user feedback.

Attitude of Health Personnel↗

Response in relation to baseline anxiety levels in major depressive disorder treated with bupropion sustained release or sertraline.

Our objective was to determine if pretreatment anxiety levels were associated with preferential response to bupropion sustained release (n = 122) or sertraline (n = 126) during a 16-week randomized acute phase treatment study. Both agents had comparable antidepressant activity, and comparable anxiolytic effects using the intent-to-treat sample. Baseline anxiety levels were not related to antidepressant efficacy, and they did not differentiate responders to each agent. Time to clinically significant anxiolysis did not differentiate between treatment groups or between responders to each agent. These results contradict the commonly held, but unsubstantiated, belief that in clinically depressed anxious patients, serotonergic antidepressants are especially anxiolytic and that such patients preferentially benefit from the antidepressant or anxiolytic effects of selective serotonin reuptake inhibitors. Thus, the clinical decision to select between these two agents when treating depressed outpatients cannot rest on either levels of pretreatment anxiety or on anticipation of more rapid or more complete anxiolysis.

Adult↗

Physical activity dose-response effects on outcomes of depression and anxiety.

PURPOSE: The purpose of this study was to examine the scientific evidence for a dose-response relation of physical activity with depressive and anxiety disorders. METHODS: Computer database searches of MEDLINE, PsychLit, and Internet and personal retrieval systems to locate population studies, randomized controlled trials (RCTs), observational studies, and consensus panel judgments were conducted. RESULTS: Observational studies demonstrate that greater amounts of occupational and leisure time physical activity are generally associated with reduced symptoms of depression. Quasi-experimental studies show that light-, moderate-, and vigorous-intensity exercise can reduce symptoms of depression. However, no RCTs have varied frequency or duration of exercise and controlled for total energy expenditure in studies of depression or anxiety. Quasi-experimental and RCTs demonstrate that both resistance training and aerobic exercise can reduce symptoms of depression. Finally, the relation of exercise dose to changes in cardiorespiratory fitness is equivocal with some studies showing that fitness is associated with reduction of symptoms and others that have demonstrated reduction in symptoms without increases in fitness. CONCLUSION: All evidence for dose-response effects of physical activity and exercise come from B and C levels of evidence. There is little evidence for dose-response effects, though this is largely because of a lack of studies rather than a lack of evidence. A dose-response relation does, however, remain plausible.

Adult↗

Which depressed patients respond to nefazodone and when?

BACKGROUND: Retrospective data analyses were conducted of a single-blind trial of 993 outpatients with nonpsychotic major depression (DSM-III-R) treated for 12 weeks with nefazodone to provide a more specific picture of the nature and timing of response or remission to acute-phase treatment. METHOD: All patients participated in a single-blind, 16-week lead-in to obtain responders eligible for a subsequent double-blind, randomized continuation phase trial. Outcomes were defined by the 17-item Hamilton Rating Scale for Depression (HAM-D). A > or = 50% reduction from baseline defined response, and a total HAM-D exit score of < or =8 defined remission. RESULTS: Of all patients who entered the trial, 41.8% (last observation carried forward) responded at or before week 4 (early responders), and an additional 25.2% responded thereafter; 18.3% achieved remission at or before week 4; 33.6% achieved remission after week 4. Thus, 77.3% of those responding ultimately remitted. On average, remission followed response by 2 weeks. The average end-of-treatment dose was 376 mg/day at exit (last observation carried forward). Responders or remitters (as opposed to nonresponders or nonremitters) had lower baseline depressive symptomatology and were more likely to be married or cohabiting. CONCLUSION: The full symptomatic benefit of antidepressant medication may not be apparent until completion of an 8- to 10-week trial. A high number of responders ultimately attained remission. Baseline demographic and clinical features were not highly predictive of who would or would not benefit from nefazodone. For routine care, a minimal acute-phase trial, using a 50% reduction in baseline symptom severity to define response, should be 8 weeks. Whether ultimate nonresponders can be identified earlier than 8 weeks deserves further study.

Adult↗

Efficacy and safety of mirtazapine in major depressive disorder patients after SSRI treatment failure: an open-label trial.

OBJECTIVE: To evaluate the efficacy and safety of mirtazapine in depressed outpatients who have shown nonresponse or intolerance to selective serotonin reuptake inhibitor (SSRI) therapy. METHOD: In this open-label, 8-week study, the efficacy and safety of mirtazapine among 103 outpatients with DSM-IV major depressive disorder who had failed previous therapy with an SSRI (fluoxetine, paroxetine, or sertraline) were evaluated. The primary efficacy measure was the 17-item Hamilton Rating Scale for Depression (HAM-D-17), and safety assessments included reported adverse events, routine laboratory assessments, physical examinations, and assessments of vital signs. A 4-day washout period followed by mirtazapine treatment was compared with an immediate switch from the SSRI to mirtazapine. RESULTS: Based on mean HAM-D-17 scores at endpoint and response rates of 48% based on the criterion of > or = 50% reduction in HAM-D-17 score, mirtazapine was found to be an effective treatment for a substantial proportion of patients for whom an SSRI was ineffective and/or poorly tolerated. Mirtazapine was well tolerated, with sedation and appetite increase/weight gain the most commonly reported adverse events. In addition, no difference in efficacy, safety, or tolerability was observed for patients undergoing an immediate switch from an SSRI (after having been tapered to the minimal effective dose) to mirtazapine, compared with those undergoing the imposition of a 4-day drug-free washout. CONCLUSION: These results suggest that an immediate switch to mirtazapine may be a valid therapeutic option among patients who cannot tolerate or do not respond to SSRIs.

Adult↗

Do bupropion SR and sertraline differ in their effects on anxiety in depressed patients?

OBJECTIVE: To examine the effects of bupropion sustained release (SR) and sertraline on anxiety in outpatients with recurrent DSM-IV-defined major depressive disorder. METHOD: This retrospective analysis was conducted using pooled data from 2 identical, 8-week, acute-phase, double-blind, placebo-controlled, parallel-group studies of bupropion SR (N = 234), sertraline (N = 225), and placebo (N = 233). Symptoms of anxiety and depression were measured using the 14-item Hamilton Rating Scale for Anxiety (HAM-A) and the 21-item Hamilton Rating Scale for Depression (HAM-D-21), respectively. Percentage reduction in baseline HAM-A total score for each treatment week was calculated to determine whether the time to onset of anxiolytic activity differed among antidepressant responders to each agent. Central nervous system (CNS) adverse events were tabulated. RESULTS: Bupropion SR and sertraline were comparably effective, both were superior to placebo in reducing depressive symptoms. and they did not differ in their effect on anxiety symptoms. Antidepressant responders (> 50% reduction in baseline HAM-D-21 score) in both groups showed marked and comparable reductions in HAM-A scores (baseline to exit). There were no differences between bupropion SR and sertraline in the median time (4 weeks) to reach a clinically significant anxiolytic effect (> or = 50% reduction in baseline HAM-A score). CNS adverse events were comparable for bupropion SR and sertraline, except for somnolence, which was more common in sertraline-treated patients. CONCLUSION: Bupropion SR and sertraline had comparable antidepressant and anxiolytic effects and an equally rapid onset of clinically significant anxiolytic activity. There was no difference in the activating effects between the 2 antidepressants. Selection between these 2 agents cannot be based on either anticipation of differential anxiolytic activity or differential CNS side effect profiles.

Adult↗

Clinical significance of monitoring early symptom change to predict outcome.

Even with efforts to develop medication algorithms for the treatment of psychiatric illnesses, there is no single authoritative method that can be used to incorporate multiple factors in the treatment decision process. For this reason, physicians are faced with the often daunting task of sifting through the numerous treatment options for psychiatric illness to develop an approach that will prove the most successful for their patients. Investigating patient patterns of response, particularly during the acute phase of treatment, and bearing them in mind when developing treatment protocols may assist clinicians in optimally managing the degree and course of symptom response. We present here a consideration of the timing and nature of response as well as individual patient predictors, which may impact therapy decisions. Furthermore, we explore the clinical significance of integrating response patterns into the treatment approach. We believe that an analysis of response patterns, in conjunction with the use of other practice guidelines, is a viable method to more effectively navigate critical decision points in the treatment process and ultimately have a dramatic effect on patient outcome.

Algorithms↗

An ideal trial to test differential onset of antidepressant effect.

Although various published clinical studies have suggested that some antidepressants may have a more rapid onset of therapeutic effect than others, none of these trials was adequately designed to measure differential time to onset of effect. Thus, existing data do not support claims that one drug reduces the symptoms of depression faster than another. In this article, we propose a study that would be ideal for measuring comparative onset of antidepressant effect. The key features of this ideal trial include (1) a prospective definition of early onset of action, (2) increased frequency of assessment, (3) a data-analytic approach capable of capturing the dynamic nature of symptomatic change, and (4) various strategies to minimize bias and heterogeneity of response.

Antidepressive Agents↗

Algorithm for the treatment of chronic depression.

Chronic depression, which is marked by a course of illness lasting 2 years or more, encompasses 4 subtypes of depressive illness: (1) chronic major depressive disorder, (2) dysthymic disorder, (3) dysthymic disorder with major depressive disorder ("double depression"), and (4) major depressive disorder with poor interepisodic recovery (i.e., in incomplete remission). In the 1990s, chronic depression had a reported prevalence rate of 3% to 5% and accounted for 30% to 35% of all cases of depression in the United States. The authors present an algorithm modified from the Texas Medication Algorithm Project for patients with chronic depression. This treatment algorithm recommends a progression of steps or stages in treating chronic depression. The first stage is monotherapy with the selective serotonin reuptake inhibitors, nefazodone, bupropion sustained release, venlafaxine extended release, mirtazapine, or psychotherapy. Later options include combination therapy, electroconvulsive therapy, atypical antipsychotics, and novel treatments. Utilization of a comprehensive treatment algorithm for chronic major depression should encourage efficient, efficacious treatment.

Algorithms↗

Regional cerebral blood flow response to oral amphetamine challenge in healthy volunteers.

UNLABELLED: Functional brain imaging is a powerful tool for examining the central nervous system (CNS) response to pharmacologic challenges. Amphetamine is of interest both because of its role as a stimulant of the dopaminergic system and because of its use to alter mood in mood-disordered patients, particularly in patients suffering from depression. In this study, we report the effects of oral D-amphetamine relative to placebo on regional cerebral blood flow (rCBF) measured by SPECT in healthy volunteers to characterize the normal CNS response to this primarily dopaminergic stimulant. METHODS: SPECT was used to assess changes in rCBF induced by amphetamine in 16 healthy volunteers. Subjects received placebo and then 0.4 mg/kg oral amphetamine in a fixed-order single-blind design and were imaged on a triple-head tomograph. Another six healthy volunteers received placebo at both times to assess normal rCBF variability. rCBF changes were assessed with a three-dimensional voxel-based analysis integrated into an automated coregistration system. Data were automatically normalized to whole-brain counts and coregistered. Resultant rCBF changes were evaluated parametrically through the formation of an image whose voxel values were based on the paired t statistic. RESULTS: Amphetamine increased rCBF in two mesial prefrontal zones (Brodmann's areas 8 and 10), inferior orbital frontal lobe (area 11), brain stem (ventral tegmentum), anteromesial temporal lobe (amygdala), and anterior thalamus. Amphetamine decreased rCBF to motor cortex, visual cortex, fusiform gyrus, posterolateral temporal lobe, and right lateral temporal lobe. CONCLUSION: Our data suggest that amphetamine induces focal increases and decreases in rCBF in healthy volunteers in areas primarily innervated by dopamine pathways and in areas with secondary (primarily limbic) affiliations. These data are consistent with glucose metabolic data from autoradiographic studies in animals, in which the largest increases are seen in brain stem, followed by striatum, thalamus, and frontal and sensory cortices. Frontopolar and temporal increases observed in our study appear to be unique to humans.

Administration, Oral↗

Occipital brain perfusion deficits in children with major depressive disorder.

UNLABELLED: Occipital lobe perfusion defects have been identified on regional cerebral blood flow (rCBF) SPECT scans of adolescent children and young adults with major depressive disorder (MDD). We reinvestigated a series of rCBF SPECT scans obtained several years ago on drug-naive children with a clinical diagnosis of MDD and on healthy children. METHODS: To test whether visually apparent abnormalities in rCBF constitute statistically significant differences between patients, given the relatively small sample sizes, we applied the technique of statistical parametric mapping (SPM). RESULTS: Two groups of patients were identified: 8 with significant posterior flow deficits in the occipital cortex (Brodmann's areas 18 and 19), usually symmetric, and best visualized on paramedian sagittal sections, and 13 without obvious occipital perfusion deficits but with anterior rCBF deficits in a pattern often described in the literature, attaining statistical significance in the right frontal region. Other localizations in the left frontal and bilateral prefrontal regions did not attain significance, but each localization contained statistically significant maxima (z scores). The scan findings of all 18 healthy children were normal. CONCLUSION: With the aid of SPM, 2 groups of children with significantly different rCBF behavior were identified. The reason for this difference is not known but should be investigated to determine its possible significance to patients with MDD.

Adolescent↗

Using treatment algorithms for the effective management of treatment-resistant depression.

Increasingly, clinicians are looking to evidence-based medicine for information about treatment options. Treatment algorithms have been used with a variety of psychiatric disorders to assist physicians in making treatment decisions. The direct, prescriptive nature of algorithms also makes them suitable for use in treatment-resistant depression. Two major projects, the Texas Medication Algorithm Project and Sequenced Treatment Alternatives to Relieve Depression, have begun to address the questions of sequenced treatment options. Future directions for algorithm development and implementation are discussed.

Algorithms↗

Sensitizing clinicians and patients to the social and functional aspects of remission.

Axis I disorders are defined by specific symptom constellations that are frequently accompanied by notable impairments in social functioning. Social role impairments diminish personal fulfillment, satisfaction, and quality of life. It is now clear that these findings suggest a broader definition of remission that involves not only the absence of symptoms but also improvement in psychosocial functioning. Clinicians and patients need to become sensitized to the role of social functioning and quality of life in the assessment of treatment outcomes. Although there has been a recent emphasis on the inclusion of social function and quality of life measures in the definition of and requirements for remission, numerous standardized scales for measuring these factors already exist. In addition, selection of efficacious therapeutic agents proven to promote both elimination of symptoms and return to full social functioning is important. Finally, significant improvement in both symptoms and function may be necessary to prevent not only relapse but also ensure full remission of anxiety and depressive disorders.

Anti-Anxiety Agents↗

A comparison of alternative assessments of depressive symptom severity: a pilot study.

This study compared the performance of an itemized symptom self-report (Inventory of Depressive Symptomatology - Self-Report; IDS-SR), patient global ratings, and clinician global ratings with an itemized clinician-rated symptom severity measure (Inventory of Depressive Symptomatology - Clinician-Rated; IDS-C) in detecting treatment effects in patients with major depressive disorder (MDD). A total of 28 inpatients (30.8% psychotic) and 34 outpatients (17.9% psychotic) with MDD began treatment that followed the Texas medication algorithm. The clinicians completed the IDS-C and a Physician Global Rating Scale (PhGRS) at each assessment visit, while the patients completed the IDS-SR and a Patient Global Rating Scale (PtGRS). Change scores from the baseline to subsequent weeks were computed for all subjects, utilizing all four measures. The IDS-SR was a significant independent predictor of the response to treatment as compared to the two global ratings. The IDS-SR was as sensitive to change as the IDS-C. While the clinician-rated itemized symptom severity rating scale remains the standard to assess the symptomatic outcome of the treatment of MDD, a self-report of identical symptomatology may be a reasonable alternative for many patients.

Adult↗

A comparison of alternative assessments of depressive symptom severity: a pilot study.

This study compared the performance of an itemized symptom self-report (Inventory of Depressive Symptomatology - Self-Report; IDS-SR), patient global ratings, and clinician global ratings with an itemized clinician-rated symptom severity measure (Inventory of Depressive Symptomatology - Clinician-Rated; IDS-C) in detecting treatment effects in patients with major depressive disorder (MDD). A total of 28 inpatients (30.8% psychotic) and 34 outpatients (17.9% psychotic) with MDD began treatment that followed the Texas medication algorithm. The clinicians completed the IDS-C and a Physician Global Rating Scale (PhGRS) at each assessment visit, while the patients completed the IDS-SR and a Patient Global Rating Scale (PtGRS). Change scores from the baseline to subsequent weeks were computed for all subjects, utilizing all four measures. The IDS-SR was a significant independent predictor of the response to treatment as compared to the two global ratings. The IDS-SR was as sensitive to change as the IDS-C. While the clinician-rated itemized symptom severity rating scale remains the standard to assess the symptomatic outcome of the treatment of MDD, a self-report of identical symptomatology may be a reasonable alternative for many patients.

Adult↗