Helena Maria Calil

Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non‐inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q‐potencies)] in acute depression, using fluoxetine as active control. Ninety‐one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day⁻¹ (up to 40 mg day⁻¹) in a prospective, randomized, double‐blind double‐dummy 8‐week, single‐center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non‐inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non‐inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non‐inferiority margin: mean differences (homeopathy‐fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double‐blind trials of homeopathy in depression and indicates the non‐inferiority of individualized homeopathic Q‐potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression.

OBJECTIVES: Our aims were to investigate the pituitary volume in patients with seasonal winter depression and healthy volunteers in winter and summer, and to assess the effects of phototherapy in these patients. METHOD: The pituitary volume of 12 patients with winter depression and 12 healthy controls, paired according gender, age and menstrual cycle, were obtained from magnetic resonance imaging in winter and summer. Eight patients were submitted to phototherapy (10000 vs. 2500 lux) in a double-blind crossover fashion during the winter, and reassessed (symptoms and magnetic resonance imaging) after treatment. RESULTS: There were no significant differences in pituitary volume between controls and patients in winter or summer. Exposure to phototherapy (10000 lux) decreased the depressive symptoms (p = 0.004), but the glandular volume did not change (p = 0.5). However, the pituitary volume in winter showed a positive correlation with the severity of depression in these patients (r = 0.69, p = 0.04). CONCLUSIONS: The results suggest that neither winter depression nor the change of seasons is associated with significant change in the pituitary volume. Despite the fact that this study was performed in a tropical area, phototherapy with 10000 lux showed to be an efficient treatment in this SAD patients sample.

BACKGROUND: Evidence for the efficacy of homeopathy for depression is limited due to lack of clinical trials of high quality. Case reports are the first steps of clinical evidence, towards controlled trials. OBJECTIVES: To report preliminary results of homeopathic treatment of depression in Jundiai's public health system, São Paulo. METHODS: Review of the medical records of new patients, treated between March and December 2006. Their diagnosis was confirmed by a semi-structured interview. Patients received individualized homeopathy and their response was measured by the Montgomery & Åsberg depression scale (MADRS). RESULTS: Fifteen patients were treated and response (more than 50% decrease of MADRS scores) was observed in 14 patients (93%), after an average of seven weeks of treatment; one patient had clinical worsening and was refered to conventional antidepressant therapy. The MADRS mean scores (± dp) decreased from 24.9 (± 5.8) to 9.7 (± 8.2, p < .0001) in the 2nd evaluation, and these results signifcance were sustained through the 3rd and 4th assessments. DISCUSSION: these results suggest that homeopathy may be an alternative therapeutics for depression, but randomized and controlled studies are needed to test the efficacy and safety of the homeopathic treatment of the depressive disorders.CONTEXTO: Não há estudos metodologicamente adequados sobre a eficácia da homeopatia na depressão. Relatos de casos clínicos são os primeiros degraus da evidência clínica, a caminho de estudos controlados. OBJETIOS: Relatar resultados preliminares do tratamento homeopático de pacientes com depressão no SUS de Jundiaí. MÉTODOS: Revisão dos prontuários dos casos novos, atendidos entre março e dezembro de 2006. O diagnóstico foi confirmado por entrevista estruturada. Os pacientes receberam homeopatia individualizada e a evolução foi avaliada pela escala de Montgomery & Åsberg (MADRS). RESULTADOS: Foram tratados 15 casos e observou-se resposta terapêutica (redução maior que 50% dos escores de depressão) em 14 pacientes (93%), após uma média de sete semanas de tratamento; um paciente apresentou piora clínica e foi encaminhado ao tratamento convencional. O escore média (± dp) na Escala de Avaliação de Depressão de Montgomery-Åsberg diminuiu de 24,9 (± 5,8) a 9,7 (± 8,2, p < ,0001) na segunda avaliação, resultados mantidos no decorrer da terceira e quarta consultas. CONCLUSÕES: Os resultados sugerem que a homeopatia pode ser uma alternativa terapêutica no tratamento da depressão, mas estudos randomizados e controlados são necessários para se testar a eficácia e segurança do tratamento homeopático dos transtornos depressivos.Universidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Departamento de PsicobiologiaFaculdade de Medicina de JundiaíUNIFESP, EPM, Depto. de PsicobiologiaSciEL

The authors perform a narrative review of literature. They describe epidemiological, biological, social, and psychological aspects linked to gender differences in depressions. There are several differences between sexes regarding depressive manifestations such as the prevalence proportion of two women to one man, thoroughly described in the literature and result of well conducted trials. However, a number of uncertainties remain in basic aspects of this subject.Os autores fazem revisão narrativa da literatura. Descrevem aspectos epidemiológicos, biológicos, sociais e psicológicos associados a diferenças devidas ao gênero nas depressões. Existem diversos tipos de diferença entre os sexos quanto a manifestações depressivas, tais como a proporção de distribuição de duas mulheres para um homem nas taxas de prevalência de depressão maior, amplamente descrita e produto de estudos bem conduzidos. Entretanto, permanecem muitas incertezas em aspectos fundamentais desse tema.Universidade Federal de São Paulo (UNIFESP) Departamento de PsicobiologiaUNIFESP, Depto. de PsicobiologiaSciEL

INTRODUCTION/OBJECTIVES: Controlled-release lithium formulations were developed to minimize elevated blood peaks, related to side-effects and intoxications. However, there is little information about the bioavailability of the only controlled-release lithium formulation available in Brazil. The objective of this study was to compare the bioavailability of controlled-release and immediate-release lithium formulations, after single and multiple doses. METHODS: Twelve healthy volunteers received 900 mg of immediate-release or controlled-release lithium carbonate in single or multiple doses during 9 days. After single dose administration, the following parameters were analyzed for each formulation: maximum lithium concentration (Cmax); time to reach Cmax (t max); area under the curve of serum concentration versus time (AUC0-12 and AUC0-¥) and the elimination half-life (t1/2 elim.). After multiple doses, Cmax; t max; AUC0-12; mean (Cmean) and minimum drug concentration (Cmin) and degree of fluctuation (DF) were analyzed. A 90% confidence interval (90%CI) for the ratio between the AUCs for each formulation was constructed. RESULTS/DISCUSSION: Following single dose, the two formulations were bioequivalent; however, they were not after multiple doses. This fact could be a consequence of methodological limitations of lithium level's measurements since, following single dose, these levels could not be detected at time periods 24 and 48h in many volunteers, compromising the calculation of t1/2 elim ,and consequently of the AUC0-¥ and the 90%CI to the ratio of these areas. Therefore, the bioequivalence found after single dose may be an unreliable result.

This study was undertaken to evaluate the acute effects of single low doses of melatonin given to healthy volunteers in the evening. Six healthy male volunteers (age range 22–24 years) participated in this study, after signing an informed consent form. They received in a double‐blind fashion placebo or 0.3 or 1.0 mg melatonin at three fixed times: 18:00, 20:00, and 21:00 hr. Polysomnographic recordings began immediately thereafter, with their being allowed to sleep. Prior to each experimental session and in the following morning, subjects completed a sleep quality questionnaire, the Profile of Mood States, the Stanford Sleepiness Scale, and underwent a visual reaction test. Significant decrease on sleep latencies was found following melatonin treatment at 18:00 and 20:00 hr. In addition, melatonin tended to improve sleep efficiency and to reduce intermittent wakefulness. However, at 21:00 hr, 0.3 mg melatonin increased latency to sleep onset and 1.0 mg melatonin had no effect on sleep variables. Furthermore, melatonin given at different times did not alter subjective sleepiness, mood, and reaction time in the following morning. The results from the present study support the notion that administration of low doses of melatonin, mimicking the nocturnal physiological concentration of this hormone may exert immediate sleep‐inducing effects.

A review of fluoxetine's safety profile, especially during long-term treatment, is presented. Key safety advantages for fluoxetine include lower adverse events and dropout rates compared with tricyclic antidepressants and other selective serotonin reuptake inhibitors (SSRIs), safety in overdose, and safe use in special population groups such as women in pregnancy. Prospectively ascertained pregnancy outcomes following exposure to SSRIs, mainly fluoxetine, consistently show no teratogenic effects as assessed in the postnatal period and in comparison with controls. An additional advantage of fluoxetine is the absence or mildness of discontinuation symptoms following treatment interruption, probably a consequence of fluoxetine's long half-life in comparison with other SSRIs. The available data on these topics confirm the suitability of long-term fluoxetine treatment.

Previous studies have shown that pretreatment with naloxone (Nlx), an opiate antagonist, attenuates the stimulating effect of ethanol. The purpose of the present study was to determine the influence of Nlx on the development and expression of the sensitization to ethanol. Initially, effects of different doses of Nlx on the response to a low dose of ethanol (2.0 g/kg) were assessed. Nlx (1.0 and 3.0 mg/kg i.p.) decreased the stimulating effect of ethanol. Groups of mice were treated with saline or Nlx (1.0 mg/kg i.p.) plus saline or ethanol (2.0 g/kg i.p.) during 21 d. On day 25 of treatment all animals received an ethanol challenge (2.0 g/kg i.p.). It significantly increased the locomotor activity of mice that had received chronic ethanol (2.0 g/kg) once daily as compared to those that had received saline. Chronic administration of Nlx (1.0 mg/kg i.p.), during the same period of time, did not change the locomotor activity of the mice. However, the group concomitantly treated with Nlx+ethanol did not develop sensitization to the locomotor-activating effect of ethanol. Another experiment was carried out to determine the effects of Nlx on the expression of sensitization to ethanol. Acute pretreatment with Nlx did not change the response of the mice that had developed sensitization to ethanol. These data show Nlx's prevention of the development of ethanol-induced sensitization but not of its expression, suggesting an important role of the opioid neurotransmitter systems modulating the development of sensitization to the locomotor-activating effect of ethanol.

The present study measured prolactin, cortisol, ACTH and growth hormone in healthy male volunteers following an acute oral administration of quetiapi