Impact of painful physical symptoms on depression outcomes in elderly Asian patients.

ABSTRACT Background: Painful physical symptoms (PPS) are prevalent among elderly patients with depression. We describe the impact of PPS on depression outcomes and quality of life (QOL) of elderly Asian patients with major depressive disorder (MDD). Methods: This post hoc analysis of data from a three-month prospective observational study of East Asian MDD in- or out-patients focused on elderly patients aged ≥60 years. Depression severity was evaluated using the Hamilton depression (HAMD-17) and clinical global impression of severity (CGI-S) scales, while QOL was measured using EuroQOL (EQ-5D and EQ-VAS) instruments. PPS were rated using the modified somatic symptom inventory (SSI). Results: At baseline, depression was moderate to severe and 49% of the 146 elderly patients were painful physical symptom positive (PPS+). Bivariate analysis showed significant correlations between PPS and depression severity and QOL at baseline. Linear regression models showed the baseline factor most significantly associated with depression severity at three months was baseline PPS status. PPS+ patients had a mean increase of 2.87 points in their HAMD-17 rating and 0.77 points in their CGI-S score. Response and remission were significantly lower in PPS+ patients; response was 60% and remission was 40% in PPS+ patients while 82% and 66% in painful physical symptom negative (PPS-) patients. QOL at endpoint was lower in PPS+ patients. Conclusions: PPS are common in elderly Asian patients with MDD and negatively influence depression outcomes and QOL. Patients with PPS had lower QOL at baseline, lower response and remission rates, higher severity of depression, and lower QOL after three months of treatment.

Predictors of psychiatric hospitalization during 6 months of maintenance treatment with olanzapine long-acting injection: post hoc analysis of a randomized, double-blind study.

BACKGROUND: Hospitalization is a costly and distressing event associated with relapse during schizophrenia treatment. No information is available on the predictors of psychiatric hospitalization during maintenance treatment with olanzapine long-acting injection (olanzapine-LAI) or how the risk of hospitalization differs between olanzapine-LAI and oral olanzapine. This study aimed to identify the predictors of psychiatric hospitalization during maintenance treatment with olanzapine-LAI and assessed four parameters: hospitalization prevalence, incidence rate, duration, and the time to first hospitalization. Olanzapine-LAI was also compared with a sub-therapeutic dose of olanzapine-LAI and with oral olanzapine. METHODS: This was a post hoc exploratory analysis of data from a randomized, double-blind study comparing the safety and efficacy of olanzapine-LAI (pooled active depot groups: 405 mg/4 weeks, 300 mg/2 weeks, and 150 mg/2 weeks) with oral olanzapine and sub-therapeutic olanzapine-LAI (45 mg/4 weeks) during 6 months' maintenance treatment of clinically stable schizophrenia outpatients (n=1064). The four psychiatric hospitalization parameters were analyzed for each treatment group. Within the olanzapine-LAI group, patients with and without hospitalization were compared on baseline characteristics. Logistic regression and Cox's proportional hazards models were used to identify the best predictors of hospitalization. Comparisons between the treatment groups employed descriptive statistics, the Kaplan-Meier estimator and Cox's proportional hazards models. RESULTS: Psychiatric hospitalization was best predicted by suicide threats in the 12 months before baseline and by prior hospitalization. Compared with sub-therapeutic olanzapine-LAI, olanzapine-LAI was associated with a significantly lower hospitalization rate (5.2% versus 11.1%, p < 0.01), a lower mean number of hospitalizations (0.1 versus 0.2, p = 0.01), a shorter mean duration of hospitalization (1.5 days versus 2.9 days, p < 0.01), and a similar median time to first hospitalization (35 versus 60 days, p = 0.48). Olanzapine-LAI did not differ significantly from oral olanzapine on the studied hospitalization parameters. CONCLUSIONS: In clinically stable schizophrenia outpatients receiving olanzapine-LAI maintenance treatment, psychiatric hospitalization was best predicted by a history of suicide threats and prior psychiatric hospitalization. Olanzapine-LAI was associated with a significantly lower incidence of psychiatric hospitalization and shorter duration of hospitalization compared with sub-therapeutic olanzapine-LAI. Olanzapine-LAI did not differ significantly from oral olanzapine on hospitalization parameters. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00088491.

Changes in adherence and treatment costs following initiation of oral or depot typical antipsychotics among previously non-adherent patients with schizophrenia.

OBJECTIVE: This study assessed the impact of depot formulations on adherence and treating costs in the naturalistic treatment of previously non-adherent outpatients with schizophrenia. METHODS: Data were taken from the European Schizophrenia Outpatient Health Outcomes (SOHO) study. Medication adherence and treating costs during an 18-month follow-up were assessed and compared for non-adherent patients initiated on depot typical (n = 262) or oral typical antipsychotics (n = 169) as monotherapy at the index visit. Multivariate analyses were employed to adjust for differences between the two groups at the index visit. RESULTS: Of the previously non-adherent patients, more than half of patients initiated on depot typicals (55%) remained adherent to medication during follow-up, whereas the equivalent was 39% for patients initiated on oral typicals. Logistic regression also showed higher odds of being adherent among the former group (Odds ratio = 1.84; 95% CI = 1.19-2.85). In addition, total costs incurred by this group during 18 months were only half those incurred by patients initiated on oral typicals (£3645 vs £7817, p < 0.05) CONCLUSIONS: Depot formulations of typical antipsychotics appeared to improve medication adherence and reduce treatment costs, compared with oral formulations, in the treatment of non-adherent patients. LIMITATION: adherence was assessed by the treating psychiatrist using a single-item.

Antipsychotic monotherapy and polypharmacy in the treatment of outpatients with schizophrenia in the European Schizophrenia Outpatient Health Outcomes Study.

This post hoc study used data from the naturalistic Schizophrenia Outpatient Health Outcomes study, assessing the factors associated with starting antipsychotic monotherapy and the annual rate and duration of antipsychotic monotherapy among patients initiating atypical antipsychotics (N = 6866). Descriptive and regression analyses were used. Factors associated with starting antipsychotic monotherapy at baseline were antipsychotic treatment for the first time, shorter duration of illness, less severe illness, and better social functioning. Baseline monotherapy was maintained throughout 12 months by 63.2% of patients and was significantly greater for olanzapine (66.8%) than for risperidone (62.8%), quetiapine (43.4%), or amisulpride (52.6%) (all p ≤ 0.01). The predicted mean number of days on baseline monotherapy was significantly longer for olanzapine than for risperidone, quetiapine, or amisulpride (all p < 0.01). Initiation of antipsychotic monotherapy at baseline is associated with select baseline patient characteristics. Olanzapine was found to have the highest monotherapy rate and the longest duration of maintained monotherapy, followed by risperidone, amisulpride, and quetiapine.

Cross-national clinical and functional remission rates: Worldwide Schizophrenia Outpatient Health Outcomes (W-SOHO) study.

BACKGROUND: Evidence suggests that schizophrenia may have a better outcome for individuals living in low- and middle-income countries compared with affluent settings. AIMS: To determine the frequency of symptom and functional remission in out-patients with schizophrenia in different regions of the world. METHOD: Using data from the Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO) study we measured clinical and functional remission in out-patients with schizophrenia in different regions of the world, and examined sociodemographic and clinical factors associated with these outcomes. The 11 078 participants analysed from 37 participating countries were grouped into 6 regions: South Europe, North Europe, Central and Eastern Europe, Latin America, North Africa and Middle East, and East Asia. RESULTS: In total, 66.1% achieved clinical remission during the 3-year follow-up (range: 60.1% in North Europe to 84.4% in East Asia) and 25.4% achieved functional remission (range: 17.8% in North Africa and Middle East to 35.0% in North Europe). Regional differences were not explained by participants' clinical characteristics. Baseline social functioning, being female and previously untreated were consistent predictors of remission across regions. CONCLUSIONS: Clinical outcomes of schizophrenia seem to be worse in Europe compared with other regions. However, functional remission follows a different pattern.

Suicidal attempts in bipolar disorder: results from an observational study (EMBLEM).

OBJECTIVES: To compare patients with and without a history of suicidal attempts in a large cohort of patients with bipolar disorder and to identify variables that are associated with suicidal behavior. METHODS: European Mania in Bipolar Longitudinal Evaluation of Medication (EMBLEM) is a two-year, prospective, observational study that enrolled 3,684 adult patients with bipolar disorder and initiated or changed oral treatment for an acute manic/mixed episode. Of those, 2,416 patients were eligible for the two-year follow-up. Only baseline characteristics were studied in the present study, included sociodemographic data, psychiatric history and comorbidities, history of suicide attempts, history of substance use problems, compliance with treatment, inpatient admissions, and functional status. Symptom severity was assessed using the Clinical Global Impression-Bipolar Disorder (CGI-BP) scale, the Young Mania Rating Scale (YMRS), and the 5-item Hamilton Depression Rating Scale (HAMD-5). A logistic regression model identified baseline variables independently associated with a history of suicidal behavior. RESULTS: Of the 2,219 patients who provided data on their lifetime history of suicide attempts, 663 (29.9%) had a history of suicidal behavior (at least one attempt). Baseline factors associated with a history of suicidal behavior included female gender, a history of alcohol abuse, a history of substance abuse, young age at first treatment for a mood episode, longer disease duration, greater depressive symptom severity (HAMD-5 total score), current benzodiazepine use, higher overall symptom severity (CGI-BP: mania and overall score), and poor compliance. CONCLUSIONS: These factors may be considered as potential characteristics to identify subjects at risk for suicidal behavior throughout the course of bipolar disorder.

Gender differences in outcomes of acute mania: a 12-month follow-up study.

This study aimed to assess short-term (12 weeks) and long-term (12 months) gender differences in the outcomes of patients experiencing an episode of mania in the course of bipolar disorder. European Mania in Bipolar Longitudinal Evaluation of Medication was a 2-year, prospective, observational study of the outcomes of patients with a manic or mixed episode conducted in 14 European countries. Data were collected during the acute phase (12 weeks) and during a follow-up period (up to 12 months). Analyses were carried out in the subgroup of patients identified with a pure manic episode at baseline. Kaplan-Meier survival analysis estimated time to first occurrence of mania improvement, worsening, recovery and depressive episode, and Cox's proportional hazards models were used to analyse factors associated with these outcomes. Overall, 2,485 patients (46.6% men, 53.4% women) were included in the analysis. Frequency of substance abuse was higher in men than women. No significant gender differences were found in the severity of manic symptoms at baseline. There were no gender differences in assessment of mania improvement, worsening or recovery over 12 weeks, but more women than men showed mania improvement over 12 months (95.4% vs. 89.2%; p < 0.01). Significantly more women developed a depressive episode over 12 weeks (14.9% vs. 9.7%; p < 0.01) and over 12 months (27.7% vs. 21.5%; p < 0.001). In conclusion, the results show that there are small gender differences in the course of patients experiencing a pure manic episode. Women had a faster time to mania improvement and a higher risk of developing a depressive episode during the 12-month follow-up period.

Incidence of extrapyramidal symptoms and tardive dyskinesia in schizophrenia: thirty-six-month results from the European schizophrenia outpatient health outcomes study.

The incidence of treatment-emergent extrapyramidal symptoms (EPSs) and tardive dyskinesia (TD) in schizophrenic patients, and the clinical characteristics associated with an increased risk of developing EPSs and TD were examined. Patients (N = 7728) in the 3-year, prospective, observational Schizophrenia Outpatient Health Outcomes study were examined according to baseline antipsychotic drug exposure. At baseline, 4893 patients (63.3%) had no EPS, and 6921 (89.6%) had no TD. Extrapyramidal symptoms and TD were assessed separately during follow-up: frequency and time to appearance from Kaplan-Meier survival curves and factors associated with time to appearance using Cox proportional hazard regression models. The cumulative incidence of EPS ranged from 7.7% (olanzapine) to 32.8% (depot typical drugs). Compared with olanzapine, patients taking depot typical drugs, oral typical drugs, risperidone, and amisulpride had a significantly higher risk of developing EPS. Differences from clozapine were marginally significant. High baseline clinical severity was associated with a significantly higher risk of developing EPS. The incidence of TD ranged from 2.8% (olanzapine) to 11.1% (depot typical agent). Compared with olanzapine, patients taking depot typical agents, oral typical agents, and risperidone had a significantly higher risk of developing TD. Baseline factors associated with a significantly higher risk of developing TD were age, EPS, a higher negative Clinical Global Impression score, and presence of gynecomastia. In summary, patients treated with typical antipsychotic agents (oral and depot) and risperidone had a higher risk of developing EPS and TD than patients treated with olanzapine. Higher baseline clinical severity was associated with EPS development, whereas age, presence of EPS, a higher negative Clinical Global Impression score, and presence of gynecomastia were associated with TD development.

Prevalence of mental disorders in primary care: results from the diagnosis and treatment of mental disorders in primary care study (DASMAP).

OBJECTIVE: Previous epidemiological studies have revealed a high prevalence of mental disorders among primary care (PC) patients. However, most studies have methodological limitations (e.g. absence of structured clinical interviews, two-phase designs) that affect the generalizability of their results. The main objective of the present study was to estimate the lifetime and 12-month prevalence of mental disorders in the PC of Catalonia (Spain), using structured clinical interviews and a one-phase design. METHODS: One-phase cross-sectional survey. A representative probability sample without replacement of individuals aged 18 years or older attending PC for a medical visit were interviewed between October 2005 and March 2006. The interviews included SCID-I for depressive and anxiety disorders and the MINI interview for other mental disorders. A total of 3,815 patients from 77 PC centres were included in the statistical analyses. RESULTS: 45.1% of respondents reported at least one lifetime mental disorder and 30.2% reported at least one mental disorder in the previous 12 months. The most common mental disorders were major depression (9.6%), panic disorder (7.0%), specific phobia (6.6%), and generalized anxiety disorder (3.8%). There was a high comorbidity between mood and anxiety disorders, as well as between mental disorders and some chronic physical conditions. CONCLUSIONS: There is a high prevalence and comorbidity of mental disorders in the PC of Catalonia. Public health policies should reinforce the role of family physicians in the detection and treatment of persons with mental disorders.

Mixed states vs. pure mania in the French sample of the EMBLEM study: results at baseline and 24 months--European mania in bipolar longitudinal evaluation of medication.

BACKGROUND: To describe the clinical course and treatment patterns over 24 months of patients experiencing an acute manic/mixed episode within the standard course of care. METHODS: EMBLEM was a 2-year European prospective, observational study on outcomes of patients experiencing a manic/mixed episode. Adults with bipolar disorder were enrolled within the standard course of care as in/outpatients if they initiated or changed oral medication for treatment of acute mania. After completing 12 weeks of acute phase, patients were assessed every 3-6 months during the maintenance phase. We present the 24 month results, with subgroup analysis for mixed states (MS) and pure mania (PM). These subgroup analyses are driven by the high proportion of antidepressants prescribed in this cohort. RESULTS: In France, 771 patients were eligible for the maintenance phase. 69% of patients completed the follow up over 24 months. The mean age was 45.5 years (sd = 13.6) with 57% of women. 504 (66%) patients were experiencing a PM and 262 (34%) a MS at baseline. The main significant differences in MS vs. PM at baseline were: a higher rate of women, and in the previous 12 months, a higher frequency of episodes (manic/mixed and depressive), more suicide attempts, more rapid cycling, fewer social activities and more work impairment. Over the 24 months of follow-up the MS group had a significantly lower recovery than PM (36% vs. 46%, p = 0.006). Overall, 42% of all patients were started on monotherapy and 58% on combination therapy; of those 35% and 30% respectively remained on their initial medication throughout the 24 months. At baseline, 36% were treated with an antidepressant, this proportion remains high throughout the follow-up period, with a significantly higher rate for MS vs. PM at 24 months (55% vs. 27%, p < 0.001). CONCLUSION: In this large sample, MS occur frequently (34%), they are more severe at baseline and have a worse functional prognosis than PM. Although antidepressants are not recommended in MS and PM, they were frequently prescribed at baseline and are maintained during the 24 months of follow-up.

Validity and reliability of the Hamilton depression rating scale (5 items) for manic and mixed bipolar disorders.

Depressive symptoms during mania have prognostic value in bipolar disorder. For depressive symptoms, it has been proposed that shorter scales should be cost-effective and practical. To determine the usefulness of 5-item Hamilton Depression Rating Scale (HAMD-5) in manic and mixed bipolar disorder, we used a four-week follow-up prospective, observational study. Convergent and discriminant validity, internal consistency, and reliability were analyzed and compared with HAMD-21, HAMD-5, and HAMD-21 cut-off points were calculated versus CGI-BP. A total of 173 manic and mixed patients were evaluated. HAMD-5 showed appropriate convergent validity, discriminant validity, internal consistency, and test-retest reliability. Discriminant validity was higher for HAMD-5 than HAMD-21. Best cut-off point of remission was: HAMD-21 < or =5 and HAMD-5 < or =1. HAMD-5 presents appropriate validity and reliability estimates. It is comparable to HAMD-21 and focuses more specifically on depressive symptoms.

Chronic mania revisited: factors associated with treatment non-response during prospective follow-up of a large European cohort (EMBLEM).

OBJECTIVE: To describe the course and outcome of patients with prospectively defined chronic mania and to identify predictors of treatment non-response. METHOD: EMBLEM is a 2-year prospective, observational study of bipolar disorder treatment outcomes conducted in 14 European countries. Patients with a manic/mixed episode were assessed and prospectively followed for 1 year. Clinical scales (Clinical Global Impressions-Bipolar Disorder (CGI-BP) overall, mania, and depression; Young Mania Rating Scale (YMRS); and five-item Hamilton Depression Rating Scale (HAM-D-5)) and medication taken were systemically recorded. Treatment adherence and outcome measures were also captured. Chronic mania (non-response) was defined as not achieving more than one point improvement on CGI-BP mania scale during up to 12-month follow-up. The analysis was conducted with 3373 patients who had at least two CGI-BP mania ratings available. RESULTS: A total of 15% of patients fulfilled criteria for chronic mania. Compared to those who responded to treatment, chronic mania was associated with lower severity of mania symptoms at baseline (OR = 0.44, 95% CI 0.37-0.52), shorter duration of current episode before treatment start (OR = 0.71, 95% CI 0.52-0.96), more delusions/hallucinations at baseline (OR = 1.12, 95% CI 1.03-1.22), less socially active (OR = 0.52, 95% CI 0.39-0.70) and greater occupational impairment (OR = 1.54, 95% CI 1.01-2.35) by multivariate statistical analysis. CONCLUSIONS: Rather than severity or duration of manic symptoms, factors associated with chronicity in mania are the presence of psychotic symptoms and issues related to social and occupational functioning.

Symptomatic remission and patient quality of life in an observational study of schizophrenia: is there a relationship?

This analysis aimed to examine the association between remission and quality of life (QOL) in schizophrenia. In post-hoc analyses of the 3-year, prospective, observational Schizophrenia Outpatients Health Outcomes (SOHO) study, we compared the QOL of patients who achieved symptomatic and clinical remission with those who did not, and the factors associated. Symptomatic remission was defined as achieving a score of ≤3 on the Clinical Global Impression-Schizophrenia (CGI-SCH) scale, maintained for 6 months and without hospitalization. QOL was patient self-rated using the European-QOL. Of the 6516 patients analyzed, 38% were in symptomatic remission 12 months post-baseline and 52% at 36 months. Functional remission remained fairly constant from 12 months to 36 months (22.4% at both time points). At all visits from 12 to 36 months, patient QOL and social functioning were significantly higher for patients in symptomatic remission. QOL was higher in patients in functional remission. Patients with maintained symptomatic remission over the 3-year follow-up had a much greater improvement in QOL than patients with no symptomatic remission or symptomatic remission for part of the period. Factors associated with a better QOL also included paid employment, socially active, a higher CGI-SCH cognitive score, good compliance, and a better baseline QOL.

Long-term functional improvements in the 2-year treatment of schizophrenia outpatients with olanzapine long-acting injection.

BACKGROUND: Little is known about the long-term changes in the functioning of schizophrenia patients receiving maintenance therapy with olanzapine long-acting injection (LAI), and whether observed changes differ from those seen with oral olanzapine. METHODS: This study describes changes in the levels of functioning among outpatients with schizophrenia treated with olanzapine-LAI compared with oral olanzapine over 2 years. This was a secondary analysis of data from a multicenter, randomized, open-label, 2-year study comparing the long-term treatment effectiveness of monthly olanzapine-LAI (405 mg/4 weeks; n=264) with daily oral olanzapine (10 mg/day; n=260). Levels of functioning were assessed with the Heinrichs-Carpenter Quality of Life Scale. Functional status was also classified as "good", "moderate", or "poor", using a previous data-driven approach. Changes in functional levels were assessed with McNemar's test and comparisons between olanzapine-LAI and oral olanzapine employed the Student's t-test. RESULTS: Over the 2-year study, the patients treated with olanzapine-LAI improved their level of functioning (per Quality of Life total score) from 64.0-70.8 (P<0.001). Patients on oral olanzapine also increased their level of functioning from 62.1-70.1 (P<0.001). At baseline, 19.2% of the olanzapine-LAI-treated patients had a "good" level of functioning, which increased to 27.5% (P<0.05). The figures for oral olanzapine were 14.2% and 24.5%, respectively (P<0.001). Results did not significantly differ between olanzapine-LAI and oral olanzapine. CONCLUSION: In this 2-year, open-label, randomized study of olanzapine-LAI, outpatients with schizophrenia maintained or improved their favorable baseline level of functioning over time. Results did not significantly differ between olanzapine-LAI and oral olanzapine.

Mixed states with predominant manic or depressive symptoms: baseline characteristics and 24-month outcomes of the EMBLEM cohort.

BACKGROUND: While factors associated with mixed states have been extensively studied, data are scant regarding the clinical heterogeneity of mixed states. The EMBLEM study was a prospective, observational study on patients with manic and mixed states. We describe and compare baseline characteristics and 24-month clinical course of mixed states with predominant depressive symptoms (MSDS) and mixed states with predominant manic symptoms (MSMS). METHODS: Adult inpatients/outpatients with bipolar disorder were enrolled within the standard course of care if they initiated or changed oral medication for acute mania or mixed states. A logistic regression was used to identify the baseline factors associated with each polarity. Comparisons with mixed episode without symptom predominance (OMS) were performed for informational purpose only. RESULTS: About 573 mixed patients were analyzed (23.7% of the cohort): 59.5% (n=341) had MSMS, 11.9% (n=68) had MSDS, and 28.6% (n=164) had OMS. At baseline, hallucinations/delusions during the index episode, inpatient status, high CGI-BP overall score, and low education level were more often associated with MSMS versus MSDS. Alcohol abuse or dependence and selective serotonin reuptake inhibitor (SSRI) or benzodiazepine use at inclusion were significantly more frequent with MSDS. MSDS had a significantly lower 24-month recurrence rate than MSMS; MSMS experienced more switches to mania whereas MSDS switched more to depression. LIMITATIONS: The post hoc dimensional definitions in the study require caution in the interpretation of the results. CONCLUSION: These results present evidence of clinical heterogeneity within mixed states. Predominant manic or depressive symptoms within mixed episode could influence clinicians' decisions in term of hospitalization, treatment, and perception of bipolar severity.

Diagnosis delay in first episodes of major depression: a study of primary care patients in Spain.

BACKGROUND: Diagnosis delay may negatively influence the clinical course of major depression; however, few studies have analysed the role of environmental factors on diagnosis delay. This study was aimed to identify personal and environmental factors related to a longer delay. METHODS: A cross-sectional observational study with 3615 primary care patients with a first diagnosis of major depression was conducted. Diagnosis delay was defined as the time between onset of symptoms and diagnosis of major depression. RESULTS: Mean of delay was 9.89 weeks. Lower years of education, triggering stressful life events before the current episode, history of previous undiagnosed depressive episodes and somatic comorbidity were related to longer delay. Health system variables, such as urban setting, public health care setting, younger doctors and female doctors were also related to a longer delay. LIMITATIONS: Onset of first depressive symptoms was retrospectively collected. The cross-sectional design does not allow making inferences about the temporal ordering between predictors and outcomes. CONCLUSIONS: Both personal and environmental variables were related to diagnosis delay. Identification of these factors helps to design early diagnosis programs to ultimate reduce the morbidity associated with major depression.

Comparison of treatment discontinuation and hospitalization among nonadherent patients initiating depot or oral typical antipsychotic medications.

This analysis compared the effectiveness (treatment discontinuation and hospitalization) of depot and oral typical antipsychotics in nonadherent outpatients with schizophrenia. Data from the 3-year, prospective, observational Schizophrenia Outpatient Health Outcome study were used. Time to treatment discontinuation, percentage of patients hospitalized and the mean numbers of hospitalizations were compared for previously nonadherent patients initiating depot typical or oral typical monotherapy. Cox proportional hazards, linear and logistic regression models were used to adjust for differences between the treatment groups at the index visit. Of 1642 nonadherent patients, 431 (26%) started an oral typical (n=169) or depot typical (n=262) antipsychotic and were included in the analysis. After adjusting for index variables, treatment discontinuation was significantly lower in the depot typical cohort (hazard ratio: 0.72, 95% confidence interval: 0.54-0.97, P<0.05). Younger age and more severe positive symptoms were also associated with higher discontinuation. The frequency of hospitalization and the mean number of hospitalizations were both significantly lower for the depot typical cohort at 6 months (P<0.05) compared with oral typicals. In the usual care of outpatients with schizophrenia, treatment continuation among nonadherent patients is longer for depot typicals compared with oral typicals and is accompanied by less hospitalization in the short term.

Schizophrenia Outpatient Health Outcomes study: twelve-month findings.

BACKGROUND: The purpose of this study was to assess the 12-month outcomes associated with naturalistic antipsychotic treatment of patients participating in the Schizophrenia Outpatient Health Outcomes (SOHO) study. METHODS: SOHO is a 3-year, prospective, observational study of the health outcomes associated with antipsychotic treatment in 10 European countries. The study included over 10,000 outpatients who were initiating or changing their antipsychotic medication. Medication use pattern, change in symptom severity, social functioning, and health-related quality of life were assessed, as well as rates of response, remission, treatment discontinuation, adverse events, and hospitalization. RESULTS: Clinical Global Impression-Severity for Schizophrenia (CGI-SCH) and quality of life scores improved in all treatment cohorts. There were greater improvements in the CGI-SCH overall symptom score and in the CGI-SCH positive, negative, cognitive, and depressive symptom scores in the olanzapine and clozapine cohorts compared with other treatment cohorts. Changes were associated with an improvement in quality of life. Patients treated with olanzapine, quetiapine, and clozapine had better tolerability per extrapyramidal symptoms and sexual-related dysfunction measures compared with patients receiving risperidone, amisulpride, or typicals. Patients treated with olanzapine had greater weight gain than patients in all other treatment cohorts. CONCLUSION: Patients initiated on olanzapine and clozapine tend to have better outcomes at 12 months than patients initiated on other antipsychotics in routine outpatient clinical practice. Results should be interpreted conservatively due to the nonrandomized study design.

Regional differences in treatment response and three year course of schizophrenia across the world.

Data from the Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO) study was used to determine the frequency of response and describe the course of disease in outpatients with schizophrenia in different regions of the world. The W-SOHO study was a 3-year, prospective, observational study that included over 17,000 outpatients with schizophrenia from 37 countries classified into six regions (Northern Europe, Southern Europe, Latin America, East Asia, Central & Eastern Europe, North Africa & Middle East). Cox proportional-hazards regression was employed to assess the factors associated with response. Multinomial logistic regression was used to assess the correlates of disease course. We found that approximately two-thirds of the patients (66.4%) achieved response during the 3-year follow up. Response rates varied across regions, and were highest in North Africa & Middle East (84.6%) and Latin America (78.6%) and lowest in Southern Europe (62.1%) and East Asia (60.9%). There were significant differences between the regions in the proportion of patients experiencing continuous remission, remission plus relapse and a persistent symptomatic course, and between the regions in the duration of remission. Overall, Latin America, East Asia, and North Africa & Middle East had more favorable outcomes because they had the largest proportion of people who achieved continuous remission, the longest time in remission and lowest percentage with a persistent symptomatic course. Having good social functioning at baseline was consistently associated with better clinical outcome. These results seem to indicate that patients from Latin America, East Asia, North Africa & Middle East may have a more favorable disease course than patients from European nations.

Factor structure, internal consistency and construct validity of the Sheehan Disability Scale in a Spanish primary care sample.

RATIONALE, AIMS AND OBJECTIVES: The Sheehan Disability Scale (SDS) is a three-item instrument that measures disability in three inter-related domains: work, family life/home responsibilities and social/leisure activities. The main objective of the present study was to examine the factor structure, reliability and construct validity of the SDS in a wide Spanish sample of primary care (PC) patients. METHODS: One phase cross-sectional survey. A total of 3815 patients, aged 18 years or older attending PC for a medical visit, were interviewed between October 2005 and March 2006. The interviews included the Structured Clinical Interview for DSM-IV Axis I Disorders for depressive and anxiety disorders, the Mini-International Neuropsychiatric Interview for the rest of mental disorders, a medical conditions checklist, the 2.0 version of the 12-item Short-Form Health Survey (SF-12) for measuring quality of life and the SDS. RESULTS: The principal component analysis and the subsequent confirmatory factor analysis indicated that the SDS is one-dimensional (normed fit index = 0.990, non-normed fit index = 0.987, comparative fit index = 0.991, goodness-of-fit index = 0.993, standardized root mean-square residual = 0.037, root mean-square error of approximation = 0.053). The internal consistency of the scale was good (α = 0.83) and it was significantly associated with the physical and mental component of the SF-12. Concerning discriminative validity, patients with major depression or panic disorder scored higher on the SDS than patients with chronic medical conditions or with no chronic pathology. We also found that a cut-off point of 8 in the SDS adequately discriminated between patients with and without depression (area under the curve = 0.814, sensitivity = 81.60%, specificity = 70.60%). CONCLUSIONS: The SDS seems a reliable, valid and useful clinical tool for measuring disability in Spanish PC patients.