Biomedical subjects

Eva Petkova

Publications and source records attributed to Eva Petkova.

16 recordsLinked to original sources

PubMed2006

Predictors of relapse in a prospective study of fluoxetine treatment of major depression.

OBJECTIVE: Loss of response to a previously effective antidepressant is a common clinical problem. Retrospective analyses have shown that the pattern of response during antidepressant treatment (late onset and persistent versus other patterns) can be used to predict relapse during continuation and maintenance treatment and possibly to identify placebo responses to treatment. This study was designed to test the predictive value of response pattern prospectively and to examine the data for other predictors of relapse. METHOD: Five hundred seventy persons with major depressive disorder were treated with fluoxetine for 12 weeks and their pattern of response was determined. Those who responded (N=292) underwent random assignment, under double-blind conditions, to continue taking fluoxetine or to switch to placebo for 52 weeks or until relapse. Survival analysis was used to examine the effect of covariates on relapse. RESULTS: Although fluoxetine was significantly more effective than placebo during maintenance treatment, this chronically ill group had a high rate of relapse. Contrary to previous findings, a pattern of acute response was not predictive of relapse. Chronicity, symptom severity, a neurovegetative symptom pattern, and female gender were all associated with a significantly greater risk of relapse, with no difference observed between fluoxetine and placebo. CONCLUSIONS: The pattern of response to acute treatment appears to be inconsistently predictive of relapse. There is a high rate of relapse with both active medication and placebo in patients with chronic depression. Illness characteristics predict loss of response both to fluoxetine and to placebo. No variable examined was predictive of differential relapse rates between fluoxetine and placebo.

Adult↗

PubMed2006

Response versus remission in obsessive-compulsive disorder.

OBJECTIVE: To investigate rates of response and remission in adults with obsessive-compulsive disorder (OCD) after 12 weeks of evidence-based treatment. METHOD: Post hoc analyses of response and remission were conducted using data from a multisite, randomized, controlled trial comparing the effects of 12 weeks of exposure and ritual prevention (EX/RP), clomipramine (CMI), their combination (EX/RP+CMI), or pill placebo (PBO) in 122 adults with OCD (DSM-III-R or DSM-IV criteria). Response was defined as a decrease in symptoms; remission was defined as minimal symptoms after treatment. Different response and remission definitions were constructed based on criteria used in prior studies. For each definition, the proportion of responders or remitters in each treatment group was then compared. RESULTS: There were significant differences (p<.05) among the 4 treatment groups in the proportion of responders and remitters. In pairwise comparisons, EX/RP+CMI and EX/RP each produced significantly more responders and remitters than PBO; CMI produced significantly more responders and remitters than PBO for some definitions but not for others. When remission was defined as a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of 12 or less, significantly more EX/RP+CMI (18/31 [58%]) and EX/RP (15/29 [52%]) patients entering treatment achieved remission than either CMI (9/36 [25%]) or PBO (0/26 [0%]) patients. However, even in treatment completers, many CMI and some EX/RP+CMI and EX/RP patients did not achieve remission (remission rates for YBOCS<or=12: EX/RP+CMI=13/19 [68%]; EX/RP=15/21 [71%]; CMI=8/27 [30%]; PBO=0/20 [0%]). CONCLUSION: EX/RP (with or without CMI) can lead to superior treatment outcome compared with CMI alone in OCD patients without comorbid depression. However, many OCD patients who receive evidence-based treatment do not achieve remission.

Adult↗

PubMed2005

Desipramine treatment of cocaine-dependent patients with depression: a placebo-controlled trial.

OBJECTIVE: The aim of this study was to test the hypothesis that desipramine would be an effective treatment in cocaine abusers with current depressive disorders. METHOD: This was a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients (N = 111) meeting DSM-III-R criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included the Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology, and the Hamilton Depression Scale (biweekly). Summary measures of mood and cocaine use outcome were compared between treatment groups with chi2- or t-tests. Dichotomous summary measures of depression response and cocaine response were the primary outcomes. Mixed effect models were also fit to explore the relationship of cocaine use to mood improvement and treatment over weeks in the trial. RESULTS: Desipramine was associated with a higher rate of depression response (51%, 28/55) than placebo (32%, 18/56) (p < 0.05), but treatment groups did not differ in rate of cocaine response. Depression improvement was associated with improvement in cocaine use. Desipramine was associated with more dropouts due to side effects and medical adverse events, while placebo was associated with more dropouts due to psychiatric worsening. CONCLUSIONS: Desipramine was an effective treatment for depression among cocaine-dependent patients. Improvement in mood was associated with improvement in cocaine abuse, but a direct effect of medication on cocaine outcome was not clearly established and rates of sustained abstinence were low. Future research should examine newer antidepressant medications with more benign side effect profiles and combinations of behavioral and pharmacological treatments to maximize effects on cocaine use.

Adult↗

PubMed2005

A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus.

BACKGROUND: Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness. METHODS: The authors conducted a randomized, controlled trial comparing telemedicine case management to usual care, with blinding of those obtaining outcome data, in 1,665 Medicare recipients with diabetes, aged 55 years or greater, and living in federally designated medically underserved areas of New York State. The primary endpoints were HgbA1c, blood pressure, and low-density lipoprotein (LDL) cholesterol levels. RESULTS: In the intervention group (n = 844), mean HgbA1c improved over one year from 7.35% to 6.97% and from 8.35% to 7.42% in the subgroup with baseline HgbA1c > or =7% (n = 353). In the usual care group (n = 821) mean HgbA1c improved over one year from 7.42% to 7.17%. Adjusted net reductions (one-year minus baseline mean values in each group, compared between groups) favoring the intervention were as follows: HgbA1c, 0.18% (p = 0.006), systolic and diastolic blood pressure, 3.4 (p = 0.001) and 1.9 mm Hg (p < 0.001), and LDL cholesterol, 9.5 mg/dL (p < 0.001). In the subgroup with baseline HgbA1c > or =7%, net adjusted reduction in HgbA1c favoring the intervention group was 0.32% (p = 0.002). Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York. CONCLUSION: Telemedicine case management improved glycemic control, blood pressure levels, and total and LDL cholesterol levels at one year of follow-up.

Aged↗

PubMed2005

Cognitive behavioral therapy and fluoxetine as adjuncts to group behavioral therapy for binge eating disorder.

OBJECTIVE: Although binge eating disorder is a common and distressing concomitant of obesity, it has not yet been established whether affected individuals presenting to behavioral weight control programs should receive specialized treatments to supplement standard treatment. This study was designed to examine the added benefit of two adjunctive interventions, individual cognitive behavioral therapy (CBT) and fluoxetine, offered in the context of group behavioral weight control treatment. RESEARCH METHODS AND PROCEDURES: One hundred sixteen overweight/obese women and men with binge eating disorder were all assigned to receive a 16-session group behavioral weight control treatment over 20 weeks. Simultaneously, subjects were randomly assigned to receive CBT+fluoxetine, CBT+placebo, fluoxetine, or placebo in a two-by-two factorial design. Outcome measures, assessed at the end of the 16-session acute treatment phase, included binge frequency, weight, and measures of eating-related and general psychopathology. RESULTS: Overall, subjects showed substantial improvement in binge eating and both general and eating-related psychopathology, but little weight loss. Subjects who received individual CBT improved more in binge frequency than did those not receiving CBT (p<0.001), and binge abstinence was significantly more common in subjects receiving CBT vs. those who did not (62% vs. 33%, p<0.001). Fluoxetine treatment was associated with greater reduction in depressive symptoms (p<0.05). The 54 subjects who achieved binge abstinence improved more on all measures than the 62 subjects who did not. In particular, these subjects lost, on average, 6.2 kg compared with a gain of 0.7 kg among non-abstainers. DISCUSSION: Adjunctive individual CBT results in significant additional binge reduction in obese binge eaters receiving standard behavioral weight control treatment.

Adult↗

PubMed2004

Post-treatment effects of exposure therapy and clomipramine in obsessive-compulsive disorder.

We sought to determine whether adults with obsessive-compulsive disorder (OCD) who respond to intensive exposure and response (ritual) prevention (EX/RP) with or without clomipramine (CMI) fare better 12 weeks after treatment discontinuation than responders receiving CMI alone. After receiving 12 weeks of treatment (EX/RP, CMI, EX/RP+CMI, or pill placebo [PBO] in a randomized clinical trial conducted at three outpatient research centers), 46 adults with OCD who responded to treatment (18 EX/RP, 11 CMI, 15 EX/RP+CMI, 2 PBO) were followed after treatment discontinuation for 12 weeks. Patients were assessed every 4 weeks with the Yale-Brown Obsessive-Compulsive Scale, the National Institutes of Health Global Obsessive-Compulsive Scale, and the Clinical Global Impressions scale by an evaluator who was blind to original treatment assignment. The primary hypothesis was that EX/RP and EX/RP+CMI responders would be less likely to relapse 12 weeks after treatment discontinuation than responders to CMI alone. Twelve weeks after treatment discontinuation, EX/RP and EX/RP+CMI responders, compared to CMI responders, had a significantly lower relapse rate (4/33 = 12% versus 5/11 = 45%) and a significantly longer time to relapse. The CMI relapse rate was lower than previously reported. Nonetheless, responders receiving intensive EX/RP with or without CMI fared significantly better 12 weeks after treatment discontinuation than responders receiving CMI alone.

Acute Disease↗

PubMed2004

Hypopharyngeal perforation near-miss during transesophageal echocardiography.

OBJECTIVES/HYPOTHESIS: The traditional blind passage of a transesophageal echocardiography probe transorally through the hypopharynx is considered safe. Yet, severe hypopharyngeal complications during transesophageal echocardiography at several institutions led the authors to investigate whether traditional probe passage results in a greater incidence of hypopharyngeal injuries when compared with probe passage under direct visualization. STUDY DESIGN: Randomized, prospective clinical study. METHODS: In 159 consciously sedated adults referred for transesophageal echocardiography, the authors performed transesophageal echocardiography with concomitant transnasal videoendoscopic monitoring of the hypopharynx. Subjects were randomly assigned to receive traditional (blind) or experimental (optical) transesophageal echocardiography. The primary outcome measure was frequency of hypopharyngeal injuries (hypopharyngeal lacerations or hematomas), and the secondary outcome measure was number of hypopharyngeal contacts. RESULTS: No perforation occurred with either technique. However, hypopharyngeal lacerations or hematomas occurred in 19 of 80 (23.8%) patients with the traditional technique (11 superficial lacerations of pyriform sinus, 1 laceration of pharynx, 12 arytenoid hematomas, 2 vocal fold hematomas, and 1 pyriform hematoma) and in 1 of 79 patients (1.3%) with the optical technique (superficial pyriform laceration) (P =.001). All traumatized patients underwent flexible laryngoscopy, but none required additional intervention. Respectively, hypopharyngeal contacts were more frequent with the traditional than with the optical technique at the pyriform sinus (70.0% vs. 10.1% [P =.001]), arytenoid (55.0% vs. 3.8% [P =.001]), and vocal fold (15.0% vs. 3.86% [P =.016]). CONCLUSION: Optically guided trans-esophageal echocardiography results in significantly fewer hypopharyngeal injuries and fewer contacts than traditional, blind transesophageal echocardiography. The optically guided technique may result in decreased frequency of potentially significant complications and therefore in improved patient safety.

Adult↗

PubMed2004

Elevated maternal interleukin-8 levels and risk of schizophrenia in adult offspring.

OBJECTIVE: Many studies have implicated prenatal infection in the etiology of schizophrenia. Cytokines, a family of soluble polypeptides, are critically important in the immune response to infection and in other inflammatory processes. The goal of this study was to determine whether second-trimester levels of four cytokines-interleukin-8 (IL-8), interleukin-1beta (IL-1beta), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)-are higher in the mothers of offspring who later developed schizophrenia spectrum disorders than in matched comparison subjects. METHOD: The authors conducted a nested case-control study of maternal serum cytokine levels in a large birth cohort, born 1959-1967. Cases (N=59) were subjects diagnosed with schizophrenia spectrum disorders (mostly schizophrenia and schizoaffective disorder) who had available second-trimester maternal serum samples. Comparison subjects (N=105) were members of the birth cohort, had not been diagnosed with a schizophrenia spectrum disorder or major affective disorder, and were matched to subjects with schizophrenia for date of birth, gender, length of time in the cohort, and availability of maternal sera. Maternal second-trimester serum levels of IL-8, IL-1beta, IL-6, and TNF-alpha were determined by sandwich enzyme-linked immunosorbent assay. RESULTS: The second-trimester IL-8 levels in mothers of offspring with schizophrenia spectrum disorders were significantly higher than those of the mothers of comparison subjects. There were no differences between subjects with schizophrenia and comparison subjects with respect to maternal levels of IL-1beta, IL-6, or TNF-alpha. CONCLUSIONS: Using prospectively collected prenatal sera in a large and well-characterized birth cohort, the authors have documented a significant association between maternal IL-8 level during the second trimester and risk of schizophrenia spectrum disorders in the offspring. These findings provide further support for a substantive role of in utero infection or inflammation in the etiology of schizophrenia. Moreover, these results may have important implications for elucidating the mechanisms by which disrupted fetal development raises the risk of this disorder.

Adult↗

PubMed2003

When should a trial of fluoxetine for major depression be declared failed?

OBJECTIVE: Although the newer antidepressants are widely used, little is known about how long it takes to see their full effect. The authors sought to determine how many weeks a fluoxetine trial with no improvement should continue before treatment is changed. METHOD: The data involved 840 patients in a 12-week open trial of fluoxetine, 20 mg/day, followed by a blinded, placebo-controlled discontinuation study. Outcomes at 4, 6, 8, 10, and 12 weeks were classified as nonresponse, partial response, response, and remission and were based on Hamilton Depression Rating Scale scores. The rate of remission at week 12 was calculated for each group of patients without remission at the earlier time points. The time to relapse during weeks 13-26 of the discontinuation study was examined in patients taking placebo and fluoxetine in relation to status at week 6. RESULTS: Patients unimproved at week 6 had a remission rate at week 12 of 31%-41%. For patients with remission at week 12, level of improvement at week 6 did not affect prognosis in weeks 13-26. Of the unimproved patients at week 8, 23% had remissions by week 12. The week 12 remission rate for unimproved patients at week 4 was clearly high enough to justify continued treatment; the rate for unimproved patients at week 10 was too low. CONCLUSIONS: These data suggest that nonresponse to fluoxetine should not be declared until 8 weeks of treatment have elapsed. Practitioners should discuss trial length with patients at the beginning of treatment.

Adolescent↗

PubMed2003

Item-by-item factor analysis of the Yale-Brown Obsessive Compulsive Scale Symptom Checklist.

Clinical subtypes of obsessive-compulsive disorder may have differing pathophysiological mechanisms and treatment outcomes. The subtypes identified by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Symptom Checklist, clustered by clinical consensus, have never been subject to statistical validation. A factor analysis using a sample of 160 patients with OCD was conducted to determine whether factor analytically derived categories are identical to extant clinically determined categories. Our analysis revealed that the contamination subtype of the Y-BOCS Symptom Checklist contains two distinct subgroups: one relating to discomfort and the other to fear of harm. If replicated on a larger scale, the finding of new subtype groupings would have important implications for future research in obsessive-compulsive disorder.

Adolescent↗

PubMed2002

A pilot placebo-controlled study of fluvoxamine for pathological gambling.

The objective of this study was to evaluate the efficacy of fluvoxamine in the treatment of pathological gambling. Thirty-two patients were treated for 6 months in a double-blind, placebo-controlled study of fluvoxamine 200 mg/day. Outcome measures included reduction in money and time spent gambling per week. Longitudinal mixed effects models and completers analyses were used for estimation and hypothesis testing. Fluvoxamine was not statistically significantly different from placebo in the overall sample. However, fluvoxamine was statistically significantly superior to placebo in males and in younger patients. The power of the study was limited by the high (59%) placebo-response rate. Fluvoxamine may be a useful treatment for certain subgroups of patients with pathological gambling. Several methodological recommendations are made for future pharmacological trials of pathological gambling.

Adult↗

PubMed2002

Menstrual functioning and psychopathology in a county-wide population of high school girls.

OBJECTIVE: To examine the association between menstrual functioning and depressive disorder symptoms (DDS), obsessive-compulsive disorder symptoms (OCDS), and eating disorder symptoms (EDS) in high school girls. METHOD: Survey data from a county-wide high school population (completion rate 91%) were used. Associations between menstrual indices and scores above clinical cutoff on the Beck Depression Inventory, Leyton Obsessive-Compulsive Inventory-Child Version, and Eating Attitudes Test were examined by using logistic regression ( = 2,547 girls). RESULTS: Controlling for chronological age and other risk factors, late menarche was associated with DDS (odds ratio [OR] = 2.26, 95% confidence interval [CI] = 1.16-4.18). Gynecological year 1 (GY1) was associated with DDS (OR = 3.13, CI = 1.23-7.33), EDS (OR = 3.11, CI = 1.00-8.09), and OCDS, both number (OR = 5.75, CI = 1.79-15.74) and interference (OR = 12.55, CI = 3.20-41.4). Secondary amenorrhea was associated with DDS (OR = 1.94, CI = 11.30-2.84) and EDS (OR = 2.32, CI = 1.51-3.49); polymenorrhea with EDS (OR = 1.92, CI = 1.27-2.86); and irregular cycles with EDS (OR = 1.70, CI = 1.11-2.54) and DDS (OR = 1.76, CI = 11.21-2.53). CONCLUSIONS: In high school girls, late menarche, GY1, and menstrual cycle abnormalities are associated differentially with DDS, OCDS, and EDS.

Adolescent↗

PubMed2002

Are there differences between women's and men's antidepressant responses?

OBJECTIVE: The study examined a large data set to determine whether patients' sex affected the outcome of antidepressant treatment. METHOD: Data for 1,746 patients aged 18-65 years who had been treated with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), fluoxetine, or placebo were examined in a retrospective analysis to determine whether men and women differed in their responses to antidepressants. To examine the effect of menopausal status in the absence of data on individual patients' menopausal status, results for female patients younger or older than age 50, 52, 54, and 56 were compared. RESULTS: Men and women both younger and older than age 50 had equivalent response rates to tricyclics and fluoxetine. Women had a statistically superior response to MAOIs. Placebo response was equivalent across all groups. CONCLUSIONS: Neither sex nor menopausal status may be relevant in antidepressant treatment of adult depressed patients up to 65 years of age. Although women had a statistically superior response to MAOIs, this difference may not be clinically relevant.

Adolescent↗

PubMed2002

Dissociation, childhood trauma, and ataque de nervios among Puerto Rican psychiatric outpatients.

OBJECTIVE: This study examined the relationships of dissociation and childhood trauma with ataque de nervios. METHOD: Forty Puerto Rican psychiatric outpatients were evaluated for frequency of ataque de nervios, dissociative symptoms, exposure to trauma, and mood and anxiety psychopathology. Blind conditions were maintained across assessments. Data for 29 female patients were analyzed. RESULTS: Among these 29 patients, clinician-rated dissociative symptoms increased with frequency of ataque de nervios. Dissociative Experiences Scale scores and diagnoses of panic disorder and dissociative disorders were also associated with ataque frequency, before corrections were made for multiple comparisons. The rate of childhood trauma was uniformly high among the patients and showed no relationship to dissociative symptoms and disorder or number of ataques. CONCLUSIONS: Frequent ataques de nervios may, in part, be a marker for psychiatric disorders characterized by dissociative symptoms. Childhood trauma per se did not account for ataque status in this group of female outpatients.

Adult↗

PubMedDate not supplied

Longitudinal comparison of depressive personality disorder and dysthymic disorder.

BACKGROUND: Few studies have compared the related diagnostic constructs of depressive personality disorder (DPD) and dysthymic disorder (DD). The authors attempted to replicate findings of Klein and Shih in longitudinally followed patients with personality disorder or major depressive disorder (MDD) in the Collaborative Longitudinal Personality Disorders Study. METHODS: Subjects (N = 665) were evaluated at baseline and over 2 years (n = 546) by reliably trained clinical interviewers using semistructured interviews and self-report personality questionnaires. RESULTS: Only 44 subjects (24.6% of 179 DPD and 49.4% of 89 early-onset dysthymic subjects) met criteria for both disorders at baseline. Depressive personality disorder was associated with increased comorbidity of some axis I anxiety disorders and other axis II diagnoses, particularly avoidant (71.5%) and borderline (55.9%) personality disorders. Depressive personality disorder was associated with low positive and high negative affectivity on dimensional measures of temperament. Depressive personality disorder subjects had lower likelihood of remission of baseline MDD at 2-year follow-up, whereas DD subjects did not. The DPD diagnosis appeared unstable over 2 years of follow-up, as only 31% (n = 47) of 154 subjects who had DPD at baseline and also had follow-up assessment met criteria on blind retesting. LIMITATIONS: Results from this sample may not generalize to other populations. CONCLUSIONS: Depressive personality disorder and dysthymic disorder appear to be related but differ in diagnostic constructs. Its moderating effect on MDD and predicted relationship to measures of temperament support the validity of DPD, but its diagnostic instability raises questions about its course, utility, and measurement.

Adolescent↗

PubMedDate not supplied

Some statistical issues in the analyses of data from longitudinal studies of elderly chronic care populations.

OBJECTIVE: This article discusses broad statistical issues common to much medical research: intent-to-treat analysis vs. completers analysis; clustered hierarchical and repeated-measures data; missing data and dropouts; and assessment of direct, indirect, and total effects. Traditional approaches and statistical techniques are reviewed and contrasted with modern methods for analysis of medical studies. METHOD: The concepts are introduced and discussed in general terms; they are illustrated with an example. The example comes from a study of the effect of residence in special care units (SCUs) for demented elderly on the daily function of nursing homes residents. More than 700 residents from 22 nursing facilities, residing in either an SCU or a non-SCU were assessed three times at approximate 6-month intervals. RESULTS: Results from both the application of traditional statistical techniques and modern methods for the analysis of repeated-measures of hierarchical multicenter data are presented, interpreted, and compared. Advantages and shortcomings of these approaches are discussed. CONCLUSION: This article advocates the use of mixed models and proper causal reasoning and terminology in the analysis and publication of results from studies on aging and life course.

Activities of Daily Living↗