Sertraline effectiveness and safety in depressed oncological patients

Goals of work Cancer is often burdened by psychological comorbidity, mainly represented by depression, anxiety and adjustment disorders. Efficacy and tolerability of sertraline in the treatment of depressive disorders is well known; however, its efficacy and safety in patients with cancer has been poorly studied. This study was aimed to provide evidences of effectiveness, safety, tolerability and rapidity of action of sertraline in a population of oncological outpatients affected by mood disorders and its effects on quality of life. Materials and methods Thirty-five adult cancer outpatients with mood depression, during chemotherapy, were enrolled to a 12-week trial with a flexible dose regime of sertraline. The treatment response was assessed at baseline, week 4 and week 12, with hospital anxiety and depression scale (HADS) and Montgomery Asberg depression rating scale (MADRS), to rate depression and anxiety; mini mental adjustment to cancer scale (Mini-MAC), to assess the psychological response to the diagnosis of cancer; clinical global impression (CGI) to evaluate severity of illness; dosage record and treatment emergent symptom scale (DOTES), to assess the adverse effects of the clinical treatments and their possible relation with the drug used; and QL index to rate quality of life. Main results Both mean depression scores, analysed by HADS and MADRS scales, and HADS anxiety scores significantly decreased during the 12 weeks of study. Mean MINI-MAC scores show that hopelessness and anxious preoccupation decreased significantly at T2 compared with T0. No severe adverse effects were observed. Conclusion In this preliminary study, sertraline was found to be effective and well tolerated in the treatment of depressed outpatients with cancer.     

Depression in lung cancer patients: is the HADS an effective screening tool?

Introduction  The present study aimed at comparing the efficacy in recognizing depression, in 53 patients newly diagnosed with lung cancer, of the Hospital Anxiety and Depression Scale (HADS), a self-report screening questionnaire, and the Montgomery-Asberg Depression Rating Scale (MADRS), a semi-structured clinician-rated interview. Specifically, we aimed at addressing the question of which is the best HADS cutoff for the detection of patients to be further investigated through a clinical semi-structured interview (the MADRS). Results  The MADRS identified 92% of the patients as depressed; the HADS, 70% and 87%, using a cutoff of 11 and 8, respectively. The results suggest substantial agreement between the HADS and the MADRS when a cutoff of 8 is used (McNemar: p = 0.51; Cohen K = 0.69), while a HADS cutoff of 11 resulted in a significantly lower concordance with the MADRS (McNemar: p = 0.002; Cohen K = 0.49).     

Screening for depressive symptoms in patients with unresectable lung cancer

Introduction Early identification of psychological distress and depression is important to optimise the quality of life in patients with advanced non-small cell lung cancer (NSCLC). The prevalence of depression may vary, depending on the time since diagnosis of cancer, results of the treatment and the prognosis. The purpose of this study was to compare the efficacy of a self-administered screening tool (Hospital Anxiety and Depression Scale (HADS)) with a health professional administered tool (Montgomery–Asberg Depression Rating Scale (MADRS)) and to explore the variability of major affective symptoms in patients with unresectable lung cancer during the initial 7–8 weeks of chemotherapy treatment for their illness. Material and methods Patients with newly diagnosed unresectable lung cancer were screened on four occasions for anxiety and depressive symptoms simultaneously using the self-rated HADS and the MADRS administered by a psycho-oncologist or a trained research associate. The first assessment was done within 1 week of diagnosis and was repeated on 3 occasions during the initial 2 cycles of chemotherapy. Results Forty-nine patients, aged 38–82 years (median age 63 years) were enrolled. All patients had advanced NSCLC (stages 3A, 3B and 4) and 61% (30 patients) had an ECOG performance status (PS) of 1 or greater. The point prevalence of depression measured by an interviewer using the MADRS at visits 1–4 was 49%, 51%, 47%, and 41%, respectively. The point prevalence of self-reported depression (HADS) was significantly (p < 0.001) lower at each assessment point (18%, 20%, 6%, 12%) compared to health professional detected depression (MADRS). Although MADRS and HADS showed very strong (Pearson’s correlation = 0.8) and significant (p < 0.001) correlation, the concordance rate in identifying the same cases of depression was only 54%. Clinical implication and conclusion The prevalence of depression among advanced lung cancer patients is high and varies very little during the first 2 cycles of chemotherapy. Among a variety of tools available for the screening of depression, a semi-structured interview is more effective at identifying clinically significant depression than a self-administered questionnaire.     

TREATMENT OF MAJOR DEPRESSION IN GENERAL PRACTICE: A DOUBLE-BLIND COMPARISON OF PAROXETINE AND LOFEPRAMINE

SUMMARY A six-week, double-blind, randomised study was used to compare the efficacy, tolerability, safety and effect on cognitive function of paroxetine with that of lofepramine in the treatment of 138 patients with major depression in general practice. Efficacy was assessed using the Montgomery and Asberg Depression Rating Scale (MADRS) and Clinical Global Impression (CGI) scale. Effect on cognitive function was assessed using the paired associate learning test and the serial ‘E’ cancellation test. The results showed that the antidepressant efficacy of paroxetine was comparable to that of lofepramine in the treatment of depressed patients. Similar improvements in mean total MADRS scores were observed in both treatment groups, but a significantly greater improvement was seen in the CGI with paroxetine at weeks 2 and 4. The effect of treatment on cognitive function did not differ significantly across the two treatment groups, nor did the number of adverse events reported nor the overall tolerability.     

Disease-Specific Depression and Outcomes in Chronic Heart Failure: A Propensity Score Analysis

Depression is common in heart failure and is associated with increased mortality. Yet, it is often underdiagnosed and inadequately treated. Lack of disease-specific and easy-to-administer screening tools is one of the reasons for underdiagnosis of depression in heart failure. We examined the effect of depression, as diagnosed by a single question about depression caused by heart failure symptoms and affecting quality of life, in a propensity score-matched cohort of heart failure patients. Of the 581 patients enrolled in the quality-of-life sub-study of the Digitalis Investigation Group trial, 298 (51%) reported that their heart failure prevented them from living as they wanted during the last month by making them feel depressed. Seventy patients (23%) who reported that they felt “much” or “very much” depressed were considered depressed for the purpose of this study. We matched 47 (67%) of these depressed patients with 47 patients from among the 283 patients without depression. Kaplan–Meier and matched Cox regression analyses were used to estimate associations of depression with mortality and hospitalizations during a median follow up of 33 months. Compared with 8 (17%) deaths in patients in the non-depressed group, 19 (40%) of those in the depressed group died from all causes [unadjusted hazard ratio (HR), 1.55; 95% confidence interval (CI), 1.004–2.39; p = 0.048]. Adjustment for propensity scores (adjusted HR, 1.77; 95% CI, 1.04–3.00; p = 0.034) or other covariates (adjusted HR, 1.85; 95% CI, 1.12–3.04; p = 0.016) did not alter the association between depression and mortality. The association, however, became marginally significant in the matched cohort (HR, 2.50; 95% CI, 0.97–6.44; p = 0.058). There was no significant association between depression and hospitalization. Baseline depression, identified by a single disease-specific question, was associated with increased mortality among ambulatory chronic heart failure patients.     

Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant

Goals of work The objective of this study was to evaluate the safety and tolerability of velafermin in patients at risk of developing severe oral mucositis (OM) from chemotherapy. Materials and methods This study was a single-center, open-label, single-dose escalation, phase I trial in patients undergoing high-dose chemotherapy (HDCT) and autologous peripheral blood stem cell transplant (PBSCT). Velafermin was administered 24 h after stem cell infusion as a single intravenous dose infused over 15 min. Clinical safety variables were assessed and OM status scored daily for 30 days using the World Health Organization (WHO) grading scale. Main results Thirty patients were treated with velafermin at doses of 0.03 (n = 10), 0.1 (n = 10), 0.2 (n = 8), or 0.33 mg/kg (n = 2). Patients were diagnosed with multiple myeloma (n = 16), non-Hodgkin’s lymphoma (n = 12), acute myelogenous leukemia (n = 1), or desmoplasmic round cell tumor (n = 1). Velafermin was well tolerated at doses up to 0.2 mg/kg. There were no drug-related serious adverse events. No patient discontinued because of adverse events; however, two patients administered 0.33 mg/kg developed adverse reactions immediately after infusion of the study drug. No other patients were treated at this dose level. The most frequent (>35% of patients) treatment-emergent adverse events were diarrhea, fatigue, pyrexia, vomiting, and nausea. Most adverse events were mild or moderate and resolved the same day without sequelae. Eight (27%) patients developed WHO grade 3 or 4 OM during the study; seven of these patients received high-dose melphalan as a conditioning regimen. Conclusion Velafermin was well tolerated by autologous PBSCT patients at doses up to 0.2 mg/kg.     

Personality and fatigue in patients with benign or malignant breast disease

Goals of work The aim of the study was to examine the role of five general personality traits in fatigue in a group of patients with breast cancer (BC) and a group with benign breast problems (BBP). Materials and methods Of the 304 participating women, 127 patients had BC and 177 BBP. A fatigue scale was completed before diagnosis and 1, 3, and 6 months after diagnosis (benign patients) or surgical treatment (BC patients). A personality questionnaire (NEO-FFI) and a depression scale (CES-D) were completed before diagnosis. Main results The BC group was less tired before diagnosis, more tired 1 month after diagnosis, and equally tired 3 and 6 months after diagnosis. In the total group, women were more tired over time when they were more neurotic, less agreeable, or more introverted. After controlling for depressive symptoms, demographics, and medical factors, baseline depressive symptoms (β = 0.29, p < 0.05), neuroticism (β = 0.29, p < 0.05), and extraversion (β = −0.25, p < 0.05) predicted fatigue 6 months later. After also including baseline fatigue, only neuroticism (β = 0.22, p < 0.05) and baseline fatigue (β = 0.79, p < 0.001) predicted fatigue. Conclusions Personality is more strongly related to fatigue than demographics, the diagnosis cancer, receiving cancer treatment, and baseline depressive symptoms and fatigue. When replicated, screening and treating women who are at risk to experience high levels of fatigue is recommended.     

Mirtazapine improves sleep and lowers anxiety and depression in cancer patients: superiority over imipramine

Goals of the work  This study aimed to compare the effectiveness of mirtazapine and imipramine on not only the distressing symptoms of cancer patients such as pain, nausea, vomiting, appetite loss, and sleep disturbances but also depressive and anxiety symptoms. Materials and methods  Fifty-three patients with cancer who were diagnosed with major depressive disorder, anxiety disorder, or adjustment disorder were included. Twenty patients on mirtazapine, 13 patients on imipramine, and 20 patients in the control group without medication were interviewed during three visits (baseline, third week, and sixth week). Pain, nausea, vomiting, appetite loss, and sleep disturbances were evaluated with self-assessment single-symptom scales during each visit. The patients were also asked to complete the Hospital Anxiety Depression Scale (HADS) during each visit. Main results  There were no significant differences among the three visits in the mirtazapine, imipramine, or control groups in terms of pain, nausea, vomiting, or appetite loss. For the initial, middle, and late insomnia, only the mirtazapine group showed improvements (p = 0.001, p = 0.001, p = 0.003). There were also significant differences in the mean total (p = 0.03), anxiety (p = 0.003), and depression (p = 0.025) scores of HADS among the three visits for patients taking mirtazapine. There were no significant differences for HADS scores from the baseline to the end point for patients taking imipramine or control group patients. Conclusion  Our findings suggest that mirtazapine is effective for resolving insomnia as well as anxiety and depressive symptoms in cancer patients. However, more systematic research, such as placebo-controlled studies, is needed.     

Patterns of fatigue related to advanced disease and radiotherapy in patients with cancer—a comparative cross-sectional study of fatigue intensity and characteristics

Goals of work  This cross-sectional comparative study was designed to explore and describe the prevalence and patterns of cancer-related fatigue in patients with advanced cancer as well as patients undergoing curative radiotherapy. Another aim was to explore the association of anxiety and depression with fatigue. Materials and methods  Patients with an advanced stage of disease (n = 228) and patients receiving radiotherapy (n = 81) completed the Borg Category Ratio Scale, the Multidimensional Fatigue Inventory and the Hospital Anxiety and Depression Scale. Main results  Patients with advanced disease had an increased probability of experiencing all aspects of fatigue except for mental fatigue as compared to patients undergoing radiation, e.g., odds ratio 11.5 (CI 5.8–22.7) for physical fatigue. Higher scores for depression than for anxiety were reported when patients had high levels of fatigue, with 23% of the patients classified as anxious and 39% depressed. Conclusions  The present study was carried out in order to address a gap in research by comparing the multidimensional aspects of fatigue in different groups of cancer patients. It is the intensity of fatigue that seems to be related to the underlying exposure to radiation or to the level of disease burden rather than the different fatigue profiles, such as the relation between physical and mental aspects.     

A RANDOMISED,DOUBLE-BLIND,PARALLEL-GROUP COMPARISON OF VENLAFAXINE AND DOTHIEPIN IN GERIATRIC PATIENTS WITH MAJOR DEPRESSION

This randomised, double-blind study conducted at nine sites in the UK and the Netherlands compared the safety and antidepressant efficacy of venlafaxine and dothiepin. Ninety-two geriatric patients (aged 64-87 years) with major depression were randomly assigned to receive either venlafaxine or dothiepin for up to 43 days. The dose of venlafaxine or dothiepin was titrated up to a maximum of 150 mg per day for the first 15 days, and thereafter could range from 50 to 150 mg per day. Adjusted mean scores on the MADRS and the HAM-D decreased significantly (p 0.05) from baseline to the end of the study in both groups. A response to therapy was observed in 60% of patients in the venlafaxine group and 53% of patients in the dothiepin group on the MADRS, and in 60% of patients in both groups on the HAM-D. Suicidal ideation scores on the MADRS were significantly (p=0.042) lower in the venlafaxine group at week 6. Treatment-emergent study events were the primary reason for withdrawal in only 7% of venlafaxine-treated patients and 8% of dothiepin-treated patients. The results confirm the efficacy and tolerability of venlafaxine for treating major depression in the elderly.     

Black cohosh (<Emphasis Type="Italic">Cimicifuga racemosa</Emphasis> [L.] Nutt.): safety and efficacy for cancer patients

Goals of work Black cohosh is commonly used to treat hot flashes and other symptoms associated with menopause. It is thought to have multiple mechanisms of action, including potential phytoestrogenic properties. This has caused some concern about its use by patients with hormone-sensitive cancer. This paper will present the results of a systematic review of the safety and efficacy of black cohosh (Cimicifuga racemosa [L.] Nutt.) in patients with cancer. Materials and methods A critical assessment of clinical (n = 5) and preclinical (n = 21) studies of black cohosh and cancer (breast and prostate) to treat hot flashes and other related symptoms is presented. In addition, clinical studies, case reports, animal studies, and in vitro assessments of the safety of black cohosh for patients with hormonally sensitive cancers is summarized and interpreted. Main results In general, the research assessing efficacy of black cohosh for the treatment of hot flashes in women with breast cancer is inconclusive. There is laboratory evidence of antiproliferative properties but no confirmation from clinical studies for a protective role in cancer prevention. Black cohosh seems to have a relatively good safety profile. Concerns about liver toxicity are inconclusive. With relevance to cancer patients, black cohosh also seems not to exhibit phytoestrogenic activity and is in fact possibly an inhibitor of tumor growth. Conclusions The use of black cohosh appears to be safe in breast cancer patients without risk for liver disease, although further research is needed in this and other populations.     

Efficacy of escitalopram in patients with severe depression: a pooled analysis

Escitalopram is an effective, well-tolerated treatment for major depressive disorder in both primary and specialist settings. This analysis compared the efficacy of escitalopram with citalopram in the treatment of patients with severe depression [defined as a score of > or =30 Montgomery-Asberg Depression Rating Scale (MADRS)]. Data from three clinical trials were used for this pooled analysis. A total of 506 severely depressed patients were included (169 received escitalopram, 171 citalopram and 166 placebo). Mean change from baseline in MADRS total scores (primary efficacy parameter) was significantly higher in the escitalopram-treated group compared with the citalopram-treated group (p = 0.003). There was a significant difference in response between escitalopram and citalopram (56 vs. 41%, respectively, p = 0.007). Results from secondary efficacy parameters (Hamilton rating for depression and Clinical Global Impression of Improvement and Severity scales) were consistent with previous results. The benefits in severe depression of escitalopram vs. citalopram were so demonstrated.     

Effects of 50mg amisulpride on EEG, psychomotor and cognitive functions in healthy sleep-deprived subjects

Amisulpride, a substituted benzamide, binds selectively to the dopamine D2- and D3-receptors. It has higher affinity for limbic compared to striatal dopamine receptors in vivo. At low doses, amisulpride facilitates dopamine transmission via a selective blockade of presynaptic D2- and D3-receptors. Amisulpride is an active antipsychotic compound effective at low doses for negative symptoms and at high doses for positive symptoms of schizophrenia. The CNS profile of multiple doses of a low dosage regimen of amisulpride (50 mg once daily for 4 days) was assessed in a randomised, double-blind, 3-way crossover, placebo-controlled study carried out in 12 young sleep-deprived (for 36 h) subjects, using EEG and various measures of psychomotor and cognitive functions. Caffeine slow release (600 mg) was used as a positive reference. Multiple doses of 50 mg amisulpride once daily were devoid of any detrimental effects on EEG and psychomotor performance and cognitive function after total sleep deprivation. In addition, 50mg amisulpride partially antagonized the deleterious effects of sleep deprivation on EEG and subjective sedation as shown by trends, and a significant increase in EEG relative beta power and a decrease in subjective sedation. These effects were more pronounced at the end of sleep deprivation, suggesting possible alerting effects of amisulpride at this dose level. Caffeine significantly antagonized the detrimental effects of sleep deprivation on vigilance (increase in EEG beta waves, speed of reaction, sustained attention and reduction in subjective sedation). In conclusion, the present results demonstrate that 50 mg amisulpride is devoid of detrimental effects on EEG, psychomotor and cognitive performance after sleep deprivation, a situation well-known to amplify such effects if they exist. Moreover, some data suggest possible alerting effects of this low dosage regimen of amisulpride.     

Needs of developing the skills of palliative care at the oncology ward

Background To clarify the prevalence and severity of the symptoms, 203 consecutive patients with breast, prostate and other cancers treated mainly for palliation were surveyed. Materials and methods The series includes 116 men and 87 women with the mean age of 65 years (range 27–86 years). The patients filled-up the Edmonton Symptom Assessment System (ESAS) questionnaire with 11 items describing cancer-related symptoms in the visual analogue scale (VAS). Results Altogether, 98% of the patients reported at least 1 of the 10 symptoms. There was a significant difference in the score frequencies between the 10 symptoms (p = 0.0001), fatigue receiving the highest frequency (50.8%) of the high scores. Fatigue was also the single most frequent symptom reported by 86.3% of the patients, followed by pain at effort (71.5%), sleeplessness (71.1%) and depression (59.0%). The most disturbing syndrome was pain (n = 48, 23.9%), followed by fatigue (n = 28, 13.9%), depression (9.5%) and dyspnoea (6.0%). Altogether, 75% had more than 5 symptoms and 10% reported all 10 symptoms. The total number of symptoms was not significantly associated with sex (p = 0.781) or age (p = 0.062), but it was associated with the diagnostic group; patients with breast cancer (n = 41) and those with prostate cancer (n = 44) reported fewer symptoms than the patients with other cancers (n = 116)(p = 0.023, Kruskal–Wallis). Conclusions Symptoms related to cancer are common among patients treated with palliative indication, but if not specifically surveyed, may remain un-detected and un-treated. ESAS as a clinical tool brings more symptoms to the attention of the physicians and helps in getting a comprehensive insight into the patient’s problems.     

An open label follow-up study on amisulpride in the add-on treatment of bipolar I patients

Background

Atypical antipsychotics are widely used in the treatment of bipolar disorders. Amisulpride is an atypical antipsychotic that has been proven to be effective in treatment of schizophrenia, major depressive disorder and, more recently, acute mania. At the moment, however, no study has assessed the effectiveness of this compound in maintenance therapy of bipolar disorders. The purpose of this study was to assess the long-term effectiveness of amisulpride in combination with standard treatments in patients with bipolar I disorder who have shown inadequate responses to ongoing standard therapies.

Methods

The study enrolled fourteen bipolar I outpatients, not responding to ongoing standard therapy. Three patients discontinued treatment but 11 were followed-up for 11.7 ± 8.2 months before (range 3–24 months) and 5.2 ± 2.7 months after the introduction of amisulpride (range 3–9 months). Relapse rates before and during treatment with amisulpride were calculated in accordance to an increase of 1 or more in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) score that was accompanied by a change in therapy or to an exacerbation of the symptoms that required hospitalization.

Results

A statistically significant decrease in overall relapse rate was observed during the period of amisulpride therapy compared with months previous to the introduction of amisulpride. The relative risk of relapse in the absence of amisulpride therapy was 3.1 (χ2 = 4.2, P < 0.05). Similarly, the rates of manic/mixed and depressive relapse were decreased but only manic episodes reached statistical significance (RR = 5.3, χ2 = 5.2, P < 0.02).

Discussion and conclusion

This open-label study suggests that long-term therapy with amisulpride may benefit patients by improving global symptoms of bipolar disorder and reducing the rate of manic/mixed relapses. Large, randomized, double-blind, placebo-controlled studies are needed to explore the benefits of adding long-term amisulpride to standard therapies for bipolar disorder.

     

Comparison of clozapine-amisulpride and clozapine-quetiapine combinations for patients with schizophrenia who are partially responsive to clozapine: A single-blind randomized study

Schizophrenia is a devastating psychiatric disorder. Clozapine has long been the gold standard for treatment of patients with treatment-resistant schizophrenia; however, some patients are only partially responsive to clozapine treatment. Augmentation of clozapine treatment might enhance its effectiveness in partial responders, but only a few studies have investigated possible augmentation strategies. This study compared the effectiveness and tolerability of the combination of amisulpride and clozapine with the combination of quetiapine and clozapine in patients who were only partially responsive to clozapine monotherapy. Fifty-six treatment-resistant patients who were partially responsive to clozapine were randomly assigned to receive amisulpride or quetiapine along with an ongoing stable dose of clozapine. Fifty patients completed the study. Patients were evaluated at baseline and at the first, third, sixth, and eighth weeks. Efficacy measures consisted of the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Scale for the Assessment of Positive Symptoms (SAPS), and the Clinical Global Impression (CGI) scale. Tolerability and adverse effects were assessed with the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale and the Simpson Angus Scale (SAS). A substantial improvement occurred in both groups by the end of the eighth week; however, the improvement associated with amisulpride was significantly greater than that seen with quetiapine. This difference was noted as early as the third week of follow-up in terms of CGI scores, and by the sixth week with regard to BPRS, SANS, and SAPS scores. Both drugs were well tolerated, as measured by UKU and SAS. Improvement favoring clozapine+amisulpride could be attributed to the selective D2/D3 binding property of amisulpride, which had an additional effect in improving symptoms of schizophrenia. The authors concluded that amisulpride seems to be effective and well tolerated for augmentation purposes in clozapine-resistant patients.     

Efficacy and tolerability of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, prospective, randomized, double-blind, active-controlled study in adult outpatients

BACKGROUND: The S-enantiomer of citalopram (escitalopram) is the active moiety linked to the anti-depressant effects associated with citalopram (the racemate). For escitalopram to be approved for the treatment of depression in Europe, findings from clinical trials of escitalopram are required to match previous results from studies of the racemate, citalopram. OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of escitalopram and citalopram in outpatients with major depressive disorder (MDD). METHODS: This prospective, randomized, double-blind, active-controlled study was conducted at 8 psychiatric outpatient clinics in the Federation of Russia. Adult outpatients aged 25 to 45 years with MDD and a total score > or =25 on the Montgomery-Asberg Depression Rating Scale (MADRS) were eligible. Patients were randomly assigned to receive 6 weeks of treatment with fixed daily doses of escitalopram 10 mg, citalopram 10 mg, or citalopram 20 mg. Efficacy assessments were made at weeks 0 (baseline), 1, 4, and 6 (study end or last observation carried forward). The primary efficacy parameter was the change from baseline in MADRS total score. Secondary measures were the change from baseline in MADRS total score in a subgroup of severely depressed patients (baseline MADRS total score, > or =35), MADRS core depression subscale score, and Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I) scores; and the proportions of patients classified as responders and remitters at study end. Tolerability was assessed using adverse events (AEs) recorded by the investigator. RESULTS: Of 330 assessable randomized patients, 8 withdrew, including 7 who withdrew consent and 1 who withdrew due to recurrence of a preexisting event. Thus, 322 patients were included in the assessment (mean age, 35 years; 41.6% male; all white; escitalopram 10 mg, 108 patients; citalopram 10 mg, 106; citalopram 20 mg, 108). At study end, the mean (SE) change from baseline in MADRS total score was significantly greater in the escitalopram arm than in the 10- and 20-rag citalopram arms (-28.70 [0.78] vs -20.11 [0.80] and -25.19 [0.78]; both, P < 0.001). Improvements were more marked in the severely depressed subgroup (-30.33 [0.95] vs -20.87 [0.99] and -26.34 [0.91]). Changes in the CGI-S and CGI-I scores and the rates of response and remission were significantly greater in the escitalopram group compared with those in the citalopram 10- and 20-mg groups (CGI-S: -2.60 [0.10] vs -1.61 [0.10] and -2.05 [0.10]; CGI-I: +1.58 [0.09] vs +2.35 [0.10] and +1.80 [0.09]; response: 95.4% vs 44.3% and 83.3%; remission: 89.8% vs 25.5% and 50.9% [all, P < 0.001]). Mean (SE) changes from baseline in core depression subscale score were -19.00 (0.59), -13.00 (0.60), and -16.52 (0.58) with escitalopram, citalopram 10 mg, and citalopram 20 mg, respectively. The prevalence of AEs was significantly lower in the escitalopram group (7) compared with the citalopram groups (16 and 19 in the 10- and 20-mg groups, respectively; both, P < 0.05). Nausea (2 [1.9%], 5 [4.7%], and 7 [6.5%] patients in the escitalopram and citalopram 10- and 20-mg groups, respectively) and headache (1 [0.9%], 2 [1.9%], and 4 [3.7%]) were the most frequently reported AEs. CONCLUSIONS: The results from this study suggest that escitalopram 10 mg was more effective than citalopram 10 and 20 mg at 6 weeks in these adult outpatients with MDD. All treatments were well tolerated.     

PATTERNS OF DEPRESSIVE SYMPTOMS IN THREE GROUPS OF DEPRESSED ADULTS

This study examined patterns of depressive symptoms experienced by acutely depressed inpatients, previously hospitalized depressed outpatients, and depressed outpatients who had never been hospitalized for depression. The groups' symptom profiles were compared to determine whether the 21 major depressive symptoms measured by the Beck Depression Inventory were similar or different for the three groups. The groups differed significantly on five depressive symptoms that are classified as affective/ cognitive symptoms (sadness, guilt, self-blame, indecisiveness, suicidal ideas) and one that is considered a somatic/vegetative symptom of depression (anorexia). Thus, commonly used diagnostic criteria may not reflect the full range or temporal patterning of symptoms experienced by depressed persons at varying levels of acuity or severity and in different treatment settings.     

Patterns of depressive symptoms in three groups of depressed adults

This study examined patterns of depressive symptoms experienced by acutely depressed inpatients, previously hospitalized depressed outpatients, and depressed outpatients who had never been hospitalized for depression. The groups' symptom profiles were compared to determine whether the 21 major depressive symptoms measured by the Beck Depression Inventory were similar or different for the three groups. The groups differed significantly on five depressive symptoms that are classified as affective/cognitive symptoms (sadness, guilt, self-blame, indecisiveness, suicidal ideas) and one that is considered a somatic/vegetative symptom of depression (anorexia). Thus, commonly used diagnostic criteria may not reflect the full range or temporal patterning of symptoms experienced by depressed persons at varying levels of acuity or severity and in different treatment settings.