Attributes of response in depressed patients switched to treatment with duloxetine.

BACKGROUND: This study was designed to assess clinical and functional outcomes associated with switching to duloxetine treatment in patients with major depressive disorder (MDD) experiencing emotional and painful physical symptoms in their current episode. METHODS: In this 8-week, multinational, multicentre, single-arm, open-label clinical trial, 242 MDD patients were switched to duloxetine 60 mg/day after selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) treatment. The primary analysis compared mean change from baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) interference score between initial responders [≥ 50% reduction from baseline on the 17-item Hamilton Depression Rating Scale (HAMD(17)) Maier subscale] and initial non-responders after 4 weeks. Initial responders continued with duloxetine 60 mg/day. Initial non-responders received duloxetine 120 mg/day for the remaining 4 weeks. Depression, pain, anxiety and functional outcomes were also compared after 8 weeks. RESULTS: BPI-SF interference decreased from baseline in initial responders (n = 108) and initial non-responders (n = 85) after 4 weeks of duloxetine treatment, with greater reductions in initial responders [BPI-SF mean difference in reduction: 1.01 (95% CI 0.42-1.61); p < 0.001]. Reductions in pain interference favouring initial responders were also apparent after 8 weeks [0.68 (95% CI: 0.03-1.33); p = 0.042]. Depression, pain, anxiety and function improved over 8 weeks across patient groups. CONCLUSIONS: Elements of core mood and pain are important residual symptoms following poor treatment response in MDD. Early improvement in these symptoms after switching to duloxetine indicated an increased chance of functional recovery.

One year follow-up of hormone replacement therapy with percutaneous estradiol and low-dose vaginal natural progesterone in women with mild to moderate hypertension.

OBJECTIVE: The effects of natural estradiol and progesterone replacement therapy on lipoprotein and cardiovascular parameters were assessed in 20 postmenopausal women with mild to moderate systemic arterial hypertension. DESIGN: After confirming hypertension in the absence of antihypertensive treatment, blood pressure control was achieved by administration of amlodipine at individually adjusted doses. Hormone replacement therapy (HRT) was introduced in a cyclic regimen (21 of 28 days) with percutaneous estradiol (1.5 mg/day) and vaginal micronized progesterone (100 mg/day). RESULTS: Blood pressure and mean heart rate remained unchanged during HRT. Serial echocardiograph scans showed no change in left ventricle mass, but a significant reduction in the thickness of the left ventricular posterior wall was observed. During treatment, patients showed little variation in total cholesterol levels (baseline: 199+/-10 mg/dl, 12 months: 202+/-11 mg/dl), as well as in high-density lipoprotein (53+/-2 to 50+/-3 mg/dl), low-density lipoprotein (122+/-10 to 118+/-11 mg/dl), and triglycerides (111+/-13 to 126+/-13 mg/dl). A subgroup of 10 patients with initial total cholesterol levels >200 mg/dl responded to HRT with a slight but significant decrease of cholesterol levels after 12 months (265+/-10 to 237+/-12 mg/dl, p<0.05, repeated measures ANOVA). HRT did not change mean antithrombin III levels and affected neither plasma renin activity nor aldosterone levels. CONCLUSION: These results suggest that the proposed HRT regimen with percutaneous estradiol associated with low-dose vaginal micronized progesterone could be a safe alternative for postmenopausal women with hypertension at least during the period required to treat menopausal symptoms.

Placebo-controlled study of tianeptine in major depressive episodes.

The efficacy and safety of tianeptine were compared, in the course of a multicentre randomised, double-blind, parallel group study, to those of placebo in the treatment of Major Depressions and Bipolar Disorder, Depressed with or without melancholia, without psychotic features. After a 1-week run-in placebo period, 126 depressed out-patients presenting DSM-III-R Major Depression or Bipolar Disorder, Depressed, with a total MADRS score of at least 25, were treated for 42 days with either tianeptine (25-50 mg/day) or placebo. Efficacy assessments were MADRS, CGI, HARS, Zung Depression Self Rating Scale and a VAS. Better efficacy of tianeptine was shown, and confirmed by covariance analyses, in final MADRS scores of the intention-to-treat population, of patients treated for at least 14 days and of completers; also in CGI items 1 and 2, MADRS item 10, and VAS. The results confirmed the efficacy of tianeptine (mean dosage: 37.5 mg/day) in the treatment of Major Depression and Bipolar Disorder, Depressed, with or without melancholia, compared to placebo. Tianeptine's acceptability did not differ from that of placebo. For adverse events, a higher incidence of headaches was found with tianeptine.

Avaliaçåo da eficácia, tolerabilidade e segurança da sertalina (50 mg a 200 mg) durante 8 semanas no tratamento de 150 pacientes ambulatoriais com depressåo maior / Evaluation of effectiveness, tolerance and safety of sertraline (50 mg to 200 mg) during 8 weeks in the treatment of 150 patients outpatients with major depression

Os resultados de um estudo multicêntrico, aberto e nåo comparativo, no qual foram avalaiados 150 pacientes com diagnóstico de depressåo maior de acordo com os critérios da DSM-III-R, såo relatados. Os pacientes selecionados foram inicialmente submetidos a um período simples-cego, durante 2 semanas. Após essa fase, aqueles que preenchiam os critérios de inclusåo e exclusåo iniciaram o tratamento com sertralina 50mg/dia que poderia ser aumentada gradualmente até 200mg/dia, incrementos de 50mg, e intervalos de no mínimo 2 semanas, caso a resposta ao tratamento fosse insatisfatória, segundo a avaliaçåo do investigador. O tratamento com sertalina mostrou-se altamente eficaz no alívio da depressåo. como também nos sintomas associados ao quadro depressivo como, ansiedade, transtornos do sono, agitaçåo ou inibiçåo psicomotora, trabalho e atividades, entre outros. Um total de 84,2 por cento dos pacientes responderam satisfatoriamente ao tratamento com sertralina em doses felíveis. Em relaçåo à tolerabilidade, um total de 54 por cento dos pacientes apresentaram algum efeito adverso ao longo do tratamento, porém estes efeitos foram geralmente de intensidade leve ou moderada e apenas 4,6 por cento dos pacientes interromperam o tratamento prematuramente devido à ocorrência de eventos adversos

Avaliacao da eficacia, tolerabilidade e seguranca da sertralina (50 mg a 200 mg) durante 8 semanas no tratamento de 150 pacientes ambulatoriais com depressao maior

Os resultados de um estudo multicentrico, aberto e nao comparativo, no qual foram avaliados 150 pacientes com diagnostico de depressao maior de acordo com os criterios do DSM-III-R, sao relatados. Os pacientes selecionados foram inicialmente submetidos a um periodo simples-cego de placebo, durante 2 semanas. Apos essa fase, aqueles que preenchiam os criterios de inclusao e exclusao iniciaram o tratamento com sertralina 50 mg/dia que poderia ser aumentada gradualmente ate 200 mg/dia, em incrementos de 50 mg, e intervalos de no minimo 2 semanas, caso a resposta ao tratamento fosse insatisfatoria, segundo a avaliacao do investigador. O tratamento com sertralina mostrou-se altamente eficaz no alivio da depressao, como tambem nos sintomas associados ao quadro depressivo como, ansiedade, transtornos do sono, agitacao ou inibicao psicomotora, trabalho e atividades, entre outras. Um total de 84,2 por cento dos pacientes responderam satisfatoriamente ao tratamento com sertralina em doses flexiveis. Em relacao a tolerabilidade, um total de 54 por cento dos pacientes apresentaram algum efeito adverso ao longo do tratamento, porem estes efeitos foram geralmente de intensidade leve ou moderada e apenas 4,6 por cento dos pacientes interromperam o tratamento premeturamente devido a ocorrencia de eventos adversos.

Dados sobre 508 casos de doença do pânico e respostas ao tratamento com alprozolam, clomipramina, imipramina e tranilcipromina / Data about 508 cases of panic disorders and response of treatment with alprazolam, clomipramine, imipramine and tranylcypromine

Quinhentos e oito casos de Doenças do Pânico foram estudados. A evitaçäo fóbica está correlacionada freqüentemente aos ataques de pânico. Em apenas 23% dos pacientes, o diagnóstico de depressäo maior, no passado ou presente, foi dado. Em 238 casos, Alprazolam, Clomipramina, Imipramina e Tranilcipromina foram efetivos em doses mais baixas do que as citadas na literatura. Como cada uma das medicaçöes tem alguns inconvenientes específicos, nenhuma foi considerada superior às outras

Dados sobre 508 casos de doenca do panico e respostas ao tratamento com alprazolam, clomipramina, imipramina e tranilcipromina

Quinentos e oito casos de Doencas do Panico foram estudados. A evitacao fobica esta correlacionada frequentemente aos ataques de panico. Em apenas 23 por cento dos pacientes, o diagnostico de depressao maior, no passado ou presente, foi dado. Em 238 casos, Alprazolam, Clomipramina, Imipramina e Tranilcipromina foram efetivos em doses mais baixas do que as citadas na literatura. Como cada uma das meditacoes tem alguns inconvenientes especificos, nenhum foi considerada superior as outras.

[The Checklist for Evaluation of Somatic Symptoms (CHESS). Its use in anxious and depressive pathology. Factor structure]. / La CH.E.S.S. Utilisation dans la pathologie anxieuse et dépressive. Structure factorielle.

The CH.E.S.S. is a new inventory for the assessment of somatic symptoms and complaints. Initialy it included 57 items (43 somatic complaints, 12 neurological signs and 2 "other symptoms"). The CH.E.S.S. was scored before treatment on two groups of patients (133 anxious and 133 depressed) with no schizophrenic or organic symptomatology. 71 somatic complaints or symptoms were identified. A principal component analysis with a subsequent Varimax rotation yelded 25 factors with 18 of clinical significance. 12 factors significantly discriminate between the two groups. Seven factors (21 items) have higher scores in depressed patients: sleep and general somatic disorders, 2) general impairment of intellectual functioning, 3) neurological, 4) neuro-muscular hypo-excitability, 5) lower limbs oedema-amimia, 6) and 7) digestive. Five factors (18 items) have higher scores in anxious patients: 1) and 2) autonomic hyperactivity, 3) neuro-muscular hyper-excitability, 4) digestive, 5) micturition disorders with limb paresthesias. According to these results the 67 items new version of the check-list (CH.E.S.S. 82) includes 51 somatic complaints or symptoms and 16 neurological signs.

Etica dos ensaios controlados em psicofarmacologia. / Ethics of the controlled trials tests in psychopharmacology

Os autores discutem alguns pontos fundamentais da elaboracao de protocolos de ensaios controlados em psicofarmacologia, salientando o respeito as consideracoes de ordem etica, baseados em certos pontos da Declaracao de Havai, diretamente aplicaveis aos ensaios clinicos. Por outro lado, sao descritos alguns elementos do protocolo experimental que suscitam problemas de ordem geral, e outros ligados a natureza dos tratamentos explorados

[Factorial analysis of the Hamilton depression scale, II]. / Structure factorielle de l'échelle de dépression de Hamilton, II.

A factorial analysis (principal components with Varimax rotation) was performed on 85 ratings of the Hamilton Depression Rating Scale obtained in 1979-1980 on inpatients with a major depressive illness. Using a replicable statistical technique, 4 factors were obtained. These factors do not overlap with those obtain on a similar sample with a similar technique nor with those obtained by other authors. It thus appears that there is no such thing as a factorial structure of this scale.

[Factorial structure of the Hamilton depression scale. I]. / Structure fractorielle de I'échelle de dépression de Hamilton. I.

A development version (N I M H 67) of the Hamilton depression rating scale with 26 items was scored on 125 depressed inpatients recently hospitalized for a major non schizophrenic depressive illness. The data were obtained before any antidepressant treatment or after an adequate wash out period. A principal component factorial analysis with Varimax rotation was used. Computer simulations showed that only 2 factors were really outside the non significant range. A criterion is defined to allow the choice of an optimal saturation threshold for inclusion of an item in a factor. It assigns 25 of the 26 items of the scale to one of 2 independent factors: depression and anxiety-somatization.