A double-blind randomized placebo-controlled study of low dose mirtazapine once daily in patients of major depressive disorders on escitalopram

Background: The SSRIs being used as 1st line therapy in treatment of depression have delayed therapeutic effect which makes the patient vulnerable to an increased risk of suicide and decreased adherence to the treatment and will prematurely discontinue the therapy. The present study was conducted to evaluate if low dose mirtazapine-escitalopram combination therapy has any add on benefit over monotherapy with escitalopram.Methods: In a single-centered, comparative study involving patients with depression attending the out-patient after screening and exclusion, 60 eligible patients were randomly assigned to receive tablet mirtazapine 7.5 mg plus tablet escitalopram 10 mg intervention or tablet escitalopram 10 mg plus placebo intervention in a double-blind 6-week treatment phase. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS) and Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline. Participants were evaluated at baseline, 1st, 2nd,4th and 6th week. Results were analyzed using Chi-Square test for adverse effects and independent t-test analysis for efficacy parameter.Results: In the analysis of results at 6th week the numbers of patients achieved remission in mirtazapine group are more with a p-value of 0.018 which is significant and the numbers of responders in mirtazapine group are also more which is statistically significant on chi-square test. There is no significant difference was observed between the two groups with reference to occurrence of adverse effect.Conclusions: Adding low dose mirtazapine has an added benefit in terms of efficacy and getting remission early with more number of responders in the treatment of major depression

Diagnosing tuberculosis among 609 adolescents (aged 12-18 years) with symptoms suggestive of tuberculosis at the Palamaner diagnostic Centre, South India

Background: Tuberculosis (TB) accounts for 1.7 million deaths, according to the recent WHO report. India alone accounts for one fifth (21%) of all the TB cases globally. Mycobacterial pathogens are classified into Typical Mycobacteria and Atypical Mycobacteria. Studies have shown that adolescents are a vulnerable age group having higher chance of getting pulmonary TB infection and disease compared to younger children and adults. This age group is a target group for vaccination. Objectives: To estimate the proportion of definite TB and probable TB in 12-18 year old adolescents. To estimate the rate of Nontuberculous Mycobacteria (NTM) in the same group. Methods: The present study is part of a prospective, observational two year cohort study conducted among school/ college going adolescents, 12-18 years in Palamaner taluk, South India during February 2007 to July 2010. A total of 609 participants attended the diagnostic ward with any of the criteria for referral. The sputum specimens were examined by concentrated AFB smear microscopy and processed for culture. Written informed assent from the subjects and consent from the parents or guardians was obtained at the time of enrollment of the participant before the start of the procedures. Results: During the 2 years follow-up of 6643 participants, 609 participants attended the diagnostic ward (DGW) for Tuberculosis testing. Among all these participants, 310 (50.9%) were males and 299 (49.1%) participants were females. 443 (72.9%) participants were referred to DGW based on TST positivity (greater than or equal to 10 mm). A total number of 7 (1.15 %) participants were diagnosed as definite TB, 3 (0.50 %) participants were diagnosed as probable TB. The proportion of 19.05% participants had NTM positive sputum samples. Participants having cough for equal to greater than 2 weeks were, 19 times more likely to become positive for M.tb growth of sputum sample (O.R = 18.60; 95% C.I = 4.02 - 86.05). There was 2 times greater chance of isolating NTM from participants who belongs to Dalit/ Harijan's community. Discussion: The proportion of the cases detected in our study was less compared to the estimation by Revised National Tuberculosis Control Programme (RNTCP), in 2007 and what other studies had shown. Most of the participants those referred to diagnostic ward did not show up for TB tests. We consider that, the NTM species isolated in our study are either by chance or by the contamination of sputum samples by environmental Mycobacteria. These isolates therefore had no clinical significance. Conclusion: Further studies need to be conducted to ascertain the actual burden of TB disease among all the adolescent age groups including people who don't go to schools. There must be further studies to find out the clinical significance of NTM among the adolescent age groups

The tuberculin skin test in school going adolescents in South India: associations of socio-demographic and clinical characteristics with TST positivity and non-response

India has generally used 1 TU purified protein derivative (PPD) as opposed to 2 TU PPD globally, limiting comparisons. It is important to assess latent TB infection in adolescents given that they may be a target group for new post-exposure TB vaccines. The aim of this study is to describe the pattern and associations of tuberculin skin test (TST) responses (0.1 ml 2 TU) in adolescents in South India. 6643 school-going adolescents (11 to <18 years) underwent TST. Trained tuberculin reader made the reading visit between 48 and 96 hours after the skin test Of 6608 available TST results, 9% had 0 mm, and 12% ≥10 mm responses. The proportion of TST positive (≥10 mm) was higher among older children, boys, those with a history of TB contact and reported BCG immunization Those with no TST response (0 mm) included younger participants ( <14 years), those whose mothers were illiterate and those with a recent history of weight loss. Those of a higher socio-economic status (houses with brick walls, LPG gas as cooking fuel) and those with a visible BCG scar were less likely to be non-responders. Proportion of non-responders was lower than elsewhere in the world. Proportion of TST positivity was higher in those already exposed to TB and in children who had been BCG immunized, with a zero response more likely in younger adolescents and those with recent weight los

Incidence of tuberculosis among school-going adolescents in South India

Background: Tuberculosis (TB) incidence data in vaccine target populations, particularly adolescents, are important for designing and powering vaccine clinical trials. Little is known about the incidence of tuberculosis among adolescents in India. The objective of current study is to estimate the incidence of pulmonary tuberculosis (PTB) disease among adolescents attending school in South India using two different surveillance methods (active and passive) and to compare the incidence between the two groups. Methods: The study was a prospective cohort study with a 2-year follow-up period. The study was conducted in Palamaner, Chittoor District of Andhra Pradesh, South India from February 2007 to July 2010. A random sampling procedure was used to select a subset of schools to enable approximately 8000 subjects to be available for randomization in the study. A stratified randomization procedure was used to assign the selected schools to either active or passive surveillance. Participants who met the criteria for being exposed to TB were referred to the diagnostic ward for pulmonary tuberculosis confirmation. A total number of 3441 males and 3202 females between the ages 11 and less than 18 years were enrolled into the study. Results: Of the 3102 participants in the active surveillance group, four subjects were diagnosed with definite tuberculosis, four subjects with probable tuberculosis, and 71 subjects had non-tuberculous Mycobacteria (NTM) isolated from their sputum. Of the 3541 participants in the passive surveillance group, four subjects were diagnosed with definite tuberculosis, two subjects with probable tuberculosis, and 48 subjects had non-tuberculosis Mycobacteria isolated from their sputum. The incidence of definite + probable TB was 147.60 / 100,000 person years in the active surveillance group and 87 / 100,000 person years in the passive surveillance group. Conclusion: The incidence of pulmonary tuberculosis among adolescents in our study is lower than similar studies conducted in South Africa and Eastern Uganda – countries with a higher incidence of tuberculosis and human immunodeficiency virus (HIV) than India. The study data will inform sample design for vaccine efficacy trials among adolescents in India