The Consortium on Vulnerability to Externalizing Disorders and Addictions (c-VEDA): an accelerated longitudinal cohort of children and adolescents in India.

The global burden of disease attributable to externalizing disorders such as alcohol misuse calls urgently for effective prevention and intervention. As our current knowledge is mainly derived from high-income countries such in Europe and North-America, it is difficult to address the wider socio-cultural, psychosocial context, and genetic factors in which risk and resilience are embedded in low- and medium-income countries. c-VEDA was established as the first and largest India-based multi-site cohort investigating the vulnerabilities for the development of externalizing disorders, addictions, and other mental health problems. Using a harmonised data collection plan coordinated with multiple cohorts in China, USA, and Europe, baseline data were collected from seven study sites between November 2016 and May 2019. Nine thousand and ten participants between the ages of 6 and 23 were assessed during this time, amongst which 1278 participants underwent more intensive assessments including MRI scans. Both waves of follow-ups have started according to the accelerated cohort structure with planned missingness design. Here, we present descriptive statistics on several key domains of assessments, and the full baseline dataset will be made accessible for researchers outside the consortium in September 2019. More details can be found on our website [cveda.org].

Adverse childhood experiences and substance misuse in young people in India: results from the multisite cVEDA cohort.

BACKGROUND: Adverse childhood experiences (ACEs) increases vulnerability to externalising disorders such as substance misuse. The study aims to determine the prevalence of ACEs and its association with substance misuse. METHODS: Data from the Consortium on Vulnerability to Externalising Disorders and Addictions (cVEDA) in India was used (n = 9010). ACEs were evaluated using the World Health Organisation (WHO) Adverse Childhood Experiences International Questionnaire whilst substance misuse was assessed using the WHO Alcohol, Smoking and Substance Involvement Screening Test. A random-effects, two-stage individual patient data meta-analysis explained the associations between ACEs and substance misuse with adjustments for confounders such as sex and family structure. RESULTS: 1 in 2 participants reported child maltreatment ACEs and family level ACEs. Except for sexual abuse, males report more of every individual childhood adversity and are more likely to report misusing substances compared with females (87.3% vs. 12.7%). In adolescents, family level ACEs (adj OR 4.2, 95% CI 1.5-11.7) and collective level ACEs (adj OR 6.6, 95% CI 1.4-31.1) show associations with substance misuse whilst in young adults, child level ACEs such as maltreatment show similar strong associations (adj OR 2.0, 95% CI 1.1-3.5). CONCLUSION: ACEs such as abuse and domestic violence are strongly associated with substance misuse, most commonly tobacco, in adolescent and young adult males in India. The results suggest enhancing current ACE resilience programmes and 'trauma-informed' approaches to tackling longer-term impact of ACEs in India. FUNDING: Newton Bhabha Grant jointly funded by the Medical Research Council, UK (MR/N000390/1) and the Indian Council of Medical Research (ICMR/MRC-UK/3/M/2015-NCD-I).

Consortium on Vulnerability to Externalizing Disorders and Addictions (cVEDA): A developmental cohort study protocol.

BACKGROUND: Low and middle-income countries like India with a large youth population experience a different environment from that of high-income countries. The Consortium on Vulnerability to Externalizing Disorders and Addictions (cVEDA), based in India, aims to examine environmental influences on genomic variations, neurodevelopmental trajectories and vulnerability to psychopathology, with a focus on externalizing disorders. METHODS: cVEDA is a longitudinal cohort study, with planned missingness design for yearly follow-up. Participants have been recruited from multi-site tertiary care mental health settings, local communities, schools and colleges. 10,000 individuals between 6 and 23 years of age, of all genders, representing five geographically, ethnically, and socio-culturally distinct regions in India, and exposures to variations in early life adversity (psychosocial, nutritional, toxic exposures, slum-habitats, socio-political conflicts, urban/rural living, mental illness in the family) have been assessed using age-appropriate instruments to capture socio-demographic information, temperament, environmental exposures, parenting, psychiatric morbidity, and neuropsychological functioning. Blood/saliva and urine samples have been collected for genetic, epigenetic and toxicological (heavy metals, volatile organic compounds) studies. Structural (T1, T2, DTI) and functional (resting state fMRI) MRI brain scans have been performed on approximately 15% of the individuals. All data and biological samples are maintained in a databank and biobank, respectively. DISCUSSION: The cVEDA has established the largest neurodevelopmental database in India, comparable to global datasets, with detailed environmental characterization. This should permit identification of environmental and genetic vulnerabilities to psychopathology within a developmental framework. Neuroimaging and neuropsychological data from this study are already yielding insights on brain growth and maturation patterns.

Initial treatment dropout in patients with substance use disorders attending a tertiary care de-addiction centre in north India.

BACKGROUND & OBJECTIVES: Dropout from substance use disorders treatment is associated with poor outcomes. Although many factors have been associated with an early dropout of patients, the reasons for dropping out of treatment prematurely remain poorly understood particularly in the Indian context. This study was aimed to study socio-demographic and clinical variables predicting initial dropout of patients attending a tertiary care de-addiction treatment centre in north India. METHODS: Information was extracted from the records of consecutive newly registered patients from January 2011 to December 2014. The patients who did not come for follow up within 30 days of the first contact were defined as initial dropouts. RESULTS: Data of 7991 patients could be retrieved. Majority of the sample consisted of male, married and employed individuals. Of them, 4907 patients (61.3%) were considered initial dropouts. Multivariate analysis revealed that after controlling for other factors, greater age, being employed, lower educational status, lesser duration of substance use, use of alcohol, opiate, tobacco, cannabis or sedative-hypnotic use but the absence of multi-substance use predicted initial drop out. INTERPRETATION & CONCLUSIONS: This study identified some socio-demographic and clinical variables which might predict treatment attrition in substance use disorders. Clinician's awareness towards these factors and tailor-made intervention might improve initial treatment retention. Future research could be directed to find the validity of this assumption.

Assist-linked brief intervention to reduce risky pattern of substance use in male workers employed at a tertiary care hospital in India: A randomized controlled trial.

Background: Substance use in workplace leads to adverse effects both on the employees and on the workplace. Existing research focuses on alcohol-related harm, while workplace use of other substances has been neglected. There are no randomized controlled studies of brief interventions in Indian hospital settings. Aim: To evaluate the efficacy of World Health Organization (WHO) alcohol, smoking, and substance involvement screening test (ASSIST)-linked brief intervention (ALBI) for reducing risky patterns of substance use in male workers at a tertiary-care hospital in North India. Material and Methods: The study was conducted in two phases. In Phase-I, a random list of 400 employees was generated from the entire pool of male hospital workers, of which 360 participated. Data on the ASSIST risk categories (mild, moderate, and high) were generated from Phase I. In Phase-II, moderate- or high-risk subjects ('ASSIST screen-positive') were randomized into intervention and control groups, with 35 screen-positive subjects in each group. The intervention group was provided a 15-30-min structured session per ALBI protocol, while the control group was given a 15-30-min general talk on health-related consequences associated with substance use. The subjects were compared on ASSIST score, WHO quality-of-life brief version (WHOQOL-BREF) and readiness to change questionnaire (RCQ) at baseline and at 3-month follow up. Results: The prevalence of moderate-to-high-risk use of tobacco, alcohol, and cannabis in the total sample was 28.6%, 27.5%, and 6.9%, respectively. At 3-months postintervention follow-up of the randomized sample, recipients of ALBI had significant reduction of ASSIST scores for all substances compared to the control group (p < 0.001). More participants receiving ALBI were ready to change to RCQ action stage (p values for tobacco, alcohol, and cannabis <0.001, <0.001 and 0.007, respectively). WHOQOL-BREF scores significantly improved in ALBI group across all domains. Conclusion: ALBI was effective in reducing risky substance use, increasing readiness to change and improving the QOL of the subjects at workplace setting.

Service users' perception and attitude toward telemedicine-based treatment for substance use disorders: A qualitative study from India.

Aim: We aimed to assess the service user's acceptability, feasibility, and attitude toward telemedicine practice and compare it with in-person consultation in substance use disorder (SUD). Materials and Methods: We recruited 15 adult patients with SUD who accessed both telemedicine and in-person care. We conducted in-depth interviews on awareness and access, facilitators and barriers, treatment satisfaction, and therapeutic relationship in the telemedicine context. We performed a conventional content analysis of the interview excerpts and used inductive and deductive coding. We assumed that social, personal, and logistic contexts influence patients' perceptions and experiences with telemedicine-based addiction care (TAC). Results: Most participants were middle-aged men (40.5 years, 86.7%), dependent on two or more substances (86.7%), and had a history of chronic, heavy substance use (use ~16 years, dependence ~11.5 years). Patients' perspectives on TAC could broadly be divided into three phases: pre-consultation, consultation, and post-consultation. Patients felt that TAC improved treatment access with adequate autonomy and control; however, there were technical challenges. Patients expressed privacy concerns and feared experiencing stigma during teleconsultation. They reported missing the elaborate inquiry, physical examination, and ritual of visiting their doctors in person. Additionally, personal comfort and technical difficulties determine the satisfaction level with TAC. Overall perception and suitability of TAC and the decision to continue it developed in the post-consultation phase. Conclusion: Our study provides an in-depth insight into the barriers and facilitators of telemedicine-based SUD treatment access, use, and retention; it also helps to understand better the choices and preferences for telehealth care vis-à-vis standard in-person care for SUDs.

Prevalence of mixed features in patients with first-episode depression: An exploratory multicentric study.

Background and Aim: There is limited literature on the prevalence of mixed features in patients with depression, especially from countries in Asia. Our aim was to evaluate the prevalence of "mixed features" in patients with first-episode depression. Materials and Methods: Patients with first-episode depression were evaluated for the presence of mixed features as per the Diagnostic and Statistical Manual (DSM)-5 criteria. They were additionally evaluated on Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS). Results: About one-sixth (16%) of the patients fulfilled the DSM-5 criteria for the mixed features specifier. The most common manic/hypomanic clinical feature was increased talkativeness or pressure of speech, followed by elevated expansive mood (12.5%), and inflated self-esteem or grandiosity was the least common feature (8.7%). Those with mixed features had higher prevalence of comorbid tobacco dependence and psychotic symptoms. In terms of frequency of depressive symptoms as assessed on HDRS, compared to those without mixed features, those with mixed features had higher frequency of symptoms such as depressed mood, insomnia during early hours of morning, work and activities, agitation, gastrointestinal somatic symptoms, genital symptoms, hypochondriasis, and poorer insight. Conclusion: Mixed features specifier criteria were fulfilled by 16% patients with first-episode depression. This finding suggests that the extension of this specifier to depression can be considered as a useful step in understanding the symptom profile of patients with depression.

Neurocognitive Analysis of Low-level Arsenic Exposure and Executive Function Mediated by Brain Anomalies Among Children, Adolescents, and Young Adults in India.

Importance: Arsenic, a contaminant of groundwater and irrigated crops, is a global public health hazard. Exposure to low levels of arsenic through food extends well beyond the areas with high arsenic content in water. Objective: To identify cognitive impairments following commonly prevalent low-level arsenic exposure and characterize their underlying brain mechanisms. Design, Setting, and Participants: This multicenter population-based cohort study analyzed cross-sectional data of the Indian Consortium on Vulnerability to Externalizing Disorders and Addictions (cVEDA) cohort, recruited between November 4, 2016, and May 4, 2019. Participants aged 6 to 23 years were characterized using deep phenotyping measures of behavior, neuropsychology, psychopathology, brain neuroimaging, and exposure to developmental adversities and environmental neurotoxins. All analyses were performed between June 1, 2020, and December 31, 2021. Exposure: Arsenic levels were measured in urine as an index of exposure. Main Outcomes and Measures: Executive function measured using the cVEDA neuropsychological battery, gray matter volume (GMV) from T1-weighted magnetic resonance imaging, and functional network connectivity measures from resting state functional magnetic resonance imaging. Results: A total of 1014 participants aged 6 to 23 years (589 male [58.1%]; mean [SD] age, 14.86 [4.79] years) were included from 5 geographic locations. Sparse-partial least squares analysis was used to describe a negative association of arsenic exposure with executive function (r = -0.12 [P = 5.4 × 10-4]), brain structure (r = -0.20 [P = 1.8 × 10-8]), and functional connectivity (within network, r = -0.12 [P = 7.5 × 10-4]; between network, r = -0.23 [P = 1.8 × 10-10]). Alterations in executive function were partially mediated by GMV (b = -0.004 [95% CI, -0.007 to -0.002]) and within-network functional connectivity (b = -0.004 [95% CI, -0.008 to -0.002]). Socioeconomic status and body mass index moderated the association between arsenic and GMV, such that the association was strongest in participants with lower socioeconomic status and body mass index. Conclusions and Relevance: The findings of this cross-sectional study suggest that low-level arsenic exposure was associated with alterations in executive functioning and underlying brain correlates. These results indicate potential detrimental consequences of arsenic exposure that are below the currently recommended guidelines and may extend beyond endemic risk areas. Precision medicine approaches to study global mental health vulnerabilities highlight widespread but potentially modifiable risk factors and a mechanistic understanding of the impact of low-level arsenic exposure on brain development.

Course and outcome of bipolar I disorder among Indian patients: A retrospective life-chart study.

Background: Indian studies on the course and outcome of bipolar disorder (BD) are scarce and their methodologies vary. Nevertheless, differences from Western ones have been noted. Methods: A systematic random sample of 200 patients with BD attending a general hospital psychiatric unit was chosen. They were assessed using the clinician and self-rated versions of the National Institute of Mental Health-Retrospective Life Charts, the lifetime version of the Columbia Suicide Severity Rating Scale, the Medication Adherence Questionnaire, the Indian Disability Evaluation and Assessment Scale, and the Presumptive Stressful Life Events Scale. Results: The mean age of onset of BD was 26 years. About 11%-13% of the illness was spent in acute episodes, mostly in depression (60%). Episode frequency was 0.4-0.6 annually. The first episode was more likely to be manic, and manic episodes outnumbered depressive episodes. The average duration of episodes was 3 months. Depressive episodes were longer and the time spent in depression was greater than mania. Psychotic symptoms (48%), a mania-depression-interval pattern (61%), and recurrent mania (19%) were common while rapid cycling and seasonal patterns were uncommon. Comorbidity (40%), functional impairment (77%), and lifetime nonadherence (58%) were high, whereas lifetime suicide attempts (16%) were low. Stressful life events were very common prior to episodes (80%), particularly early in the illness. Conclusion: This study suggests differences between Indian and Western patients in the demographic profile and the course and outcome of BD. A more benign presentation in the current study including Indian studies is indicated by their later age of presentation and illness onset, higher rates of marriage, education, and employment, a mania predominant course, lower rates of rapid cycling, comorbidity, and suicidal attempts. Factors associated with better outcomes such as longer time to recurrence, Manic Depressive pattern of illness, and low rates of hospitalizations also appear to be commoner in our study and also in other Indian studies.

Course and Correlates of Stigma in Patients on Opioid Agonist Treatment: A Prospective Study from an Outpatient Treatment Program in India.

Background: Individuals with opioid dependence experience stigma and discrimination. Stigma can potentially reduce treatment-seeking and negatively affect treatment outcomes. We aimed to study the course of stigma and its correlates among patients receiving opioid agonist treatment (OAT). Methods: We recruited 51 subjects (aged between 18 and 45 years) registered in the OAT clinic from February to September 2019. We excluded subjects dependent on alcohol and other drugs (except for cannabis and tobacco), with severe mental illness, intellectual disability, and organic brain disease. We assessed the internalized and enacted stigma and quality of life at the treatment entry and after 3 months. Relationship of stigma with quality of life, socio-demographic, and other clinical variables were examined at the treatment entry. Results: Mean age of the subjects was 26.7 (± 5) years. At the end of three months, 33 (64.7%) patients were retained in the treatment. Internalized stigma correlated negatively with the social and environmental domains of quality of life. The strength of the correlations was modest. No significant correlation was found between demographic and clinical variables and internalized stigma and enacted stigma scores. Both internalized and enacted stigma scores reduced significantly at 3 months follow-up. The significance levels were retained even after controlling for the baseline quality of life scores. Stigma at the treatment entry did not predict early dropout. Conclusion: Despite higher severity at the treatment entry, the level of internalized and enacted stigma reduced significantly within three months of an outpatient-based OAT program.

The therapeutic relationships, empathy, and satisfaction in teleconsultation for substance use disorders: Better or worse than in-person consultation?

Context: Telemedicine has become one of the essential modes of healthcare delivery. Different aspects of the physician-patient relationship during tele and in-person consultation need to be studied. Aims: This study aimed to compare perceived empathy and therapeutic relationship between tele and in-person consultation and assess the patient's satisfaction during teleconsultation for substance use disorder (SUD). Methodology: We consecutively recruited 100 adult patients with SUD, registered to the tele-addiction service between June and September 2020, and experienced both video and in-person consultations. We assessed therapeutic relationships, perceived empathy (for teleconsultation and in-person consultation), and patients' satisfaction (with teleconsultation) with specific scales. We compared the scores of the therapeutic relationship and physician empathy scales for tele and in-person consultation. Results: The mean age of the patients was 35.5 (±10.4) years. Sixty percent had alcohol, followed by opioids (42%) and cannabis dependence (24%). Sixty percent of patients had comorbid tobacco dependence. Telehealth satisfaction (TSS) rating shows around 40% of patients had difficulty accessing the telehealth service and 7% felt their privacy was poorly respected. The mean total therapeutic relation (STAR) (t = -14.4; P <.001), positive collaboration (t = -12.8; P <.001), positive clinical input (t = -11.9; P <.001), and total Patient's Perceptions of Physician Empathy (PPPE) score (t = -8.4; P < .001) were lower in the teleconsultation than in-person consultation group. TSS was positively correlated with positive collaboration, positive clinician input, and STAR total score. Conclusions: Our study suggests a stronger therapeutic relationship and higher physician empathy during in-person consultations. Poor accessibility and privacy concerns were critical challenges in telehealth service. TSS and therapeutic relationships positively influence each other.

Social cognition in siblings of patients with bipolar disorders.

BACKGROUND: Identifying people at risk of developing bipolar disorder (BD) using endophenotypes is of recent interest. Few studies on social cognition in first-degree relatives of patients with BD have shown inconsistent findings. This study aimed to evaluate the social cognitive deficits (SCD) and its correlates among siblings of patients with BD. METHODOLOGY: In this cross-sectional study, patients of BD (n = 32), their siblings (n = 32), and healthy control (HC) subjects (n = 38) matched for age, gender, and education were evaluated on social cognition rating tools in Indian setting and neurocognitive tests (color trail test, Wisconsin card sorting test [WCST], and Hopkin's verbal learning test [HVLT]). RESULTS: When the siblings of patients with BD were compared with patients with BD and the HCs, siblings (mean 0.6 [standard deviation [SD]: 0.2]) performed worse than the HCs (mean 0.9 [SD: 0.1]) (P ≤ 0.001) on the Faux pas composite index. Compared to HCs, siblings performed worse on all the subtests of HVLT (Trial delayed) (P < 0.001) and WCST (total correct, total errors, and conceptual responses) (P < 0.001). CONCLUSION: Presence of elevated level of SCD among siblings, especially the Faux pas composite index in comparison to HCs, imply that these are stable traits, which are more often present in the patients and at risk individuals. This implies that SCD can be considered as another important endophenotype for BD.

Opioid substitution therapy with buprenorphine-naloxone during COVID-19 outbreak in India: Sharing our experience and interim standard operating procedure.

Coronavirus disease 2019 (COVID-19) has been declared as a pandemic by the World Health Organization on March 11, 2020. It has affected most countries of the world, including India. Both the disease and the unavoidable national response to it have posed unique challenges to our health-care system. A particular vulnerable group of patients is those with opioid dependence maintained on opioid substitution therapy (OST). These patients are pharmacologically dependent on the OST medication (buprenorphine, buprenorphine-naloxone combination [BNX], and methadone) for their healthy functioning and recovery. COVID-19 outbreak, lock-down, and difficult access to medical care, all are likely to induce stress and withdrawal, which is a potential risk for relapse among individuals with opioid dependence, who are anyway more vulnerable due to social, housing, living, and medical conditions. In this context, it is essential to re-strategize the existing OST services to adapt to the challenging circumstances. In this communication, we share our experience and formulate interim standard operating procedures (SOPs) for running a hospital-based OST service utilizing take-home BNX. The challenges, principles to meet the challenges, and interim SOPs are shared as being currently practiced in our center. Individual institutes, agencies, hospitals, and clinics running OST service with BNX can adapt these SOPs according to their characteristics, needs, demand, and resources; so long as, the basic principles are adhered to.

Tapentadol, the new kid on the block in India: Is it time to worry?

BACKGROUND AND OBJECTIVES: Large-scale prospective case series of tapentadol abuse or dependence in India is not available. Hence, we aimed to study the prevalence and profile of tapentadol users in a treatment-seeking population. MATERIALS AND METHODS: The study had prospective and retrospective arms. We collected 8-month prospective data by face-to-face interviews (n = 70) and 8-year retrospective data from case notes (n = 26) with either tapentadol misuse/abuse or dependence in patients attending a de-addiction center. RESULTS: The prevalence of tapentadol abuse or dependence was 25% among the pharmaceutical opioid users. Concurrent use of other opioids was seen in >80% of participants of both the arms. Major sources of tapentadol were chemists (without a prescription) (53%) and doctors (prescriptions) (40%). Patients in the tapentadol dependence group had a significantly higher dose, duration, and pharmaceutical opioid use. CONCLUSION: India needs awareness promotion, training, availability restriction, and provision of treatment for tapentadol abuse or dependence.

Neurocognitive functions in patients on buprenorphine maintenance for opioid dependence: A comparative study with three matched control groups.

BACKGROUND: Neurocognitive dysfunction with buprenorphine has mixed evidence, with many confounding factors. We compared the neurocognitive functions in patients with opioid dependence on buprenorphine maintenance (Index Group; IG) with those on naltrexone (NG), opioid-dependent in early detoxification (OD), and healthy control (CG). MATERIALS & METHODS: The four groups were matched for age, sex, and years of education. Except for the healthy control group (CG; n = 30), the two other comparison groups had twenty participants each. Subjects with other substance use disorders, HIV infection, head injury, epilepsy, and severe mental illness were excluded. Cognitive tests consisted of Trail Making Tests (TMT-A & B), Digit Vigilance test (DVT), verbal and visual N-Back Test (NBT), Rey's Auditory Verbal Learning Test (RAVLT), Wisconsin Card Sorting Test (WCST), Controlled Oral Word Association Test (COWA), and Wechsler Adult Intelligence Scale (WAIS). RESULTS: IG performed significantly worse in TMT-B, DVT, verbal NBT, and WCST (non-perseverative error) than CG. When IQ was controlled for, significance persisted in TMT-B, a marker of poor cognitive flexibility. The OD showed significantly poorer performance than NG and CG in the TMT-A & B, visual and verbal NBT, DVT, and RAVLT. When compared to the IG, the performance of the OD was significantly poor in the TMT-A & B. IG performed worse than NG in TMT-B, and NG performed poorer (than CG) in RAVLT. CONCLUSION: Patients on medication-assisted treatment had significant cognitive impairment limited to fewer cognitive domains, however, the extent and severity were highest in the group with active opioid dependence.

Sexual dysfunction in men on buprenorphine - naloxone-based substitution therapy.

BACKGROUND: The literature on sexual dysfunction in patients on buprenorphine-naloxone (BNX) substitution is limited. MATERIALS AND METHODS: This research aimed to study the prevalence and correlates of sexual dysfunction in men on BNX substitution therapy. We recruited consecutive forty men from BNX clinic, who had received BNX for at least 6 months, who were free from any recent illicit drug use (confirmed by urine chromatographic immune assay), and who were either married or had a stable sexual partner. Men with other psychiatric and substance use disorders (except tobacco) were excluded from the study. Data for the control group were obtained from a published study (with similar selection criteria) from our center. We assessed sexual dysfunction with two cross-culturally validated instruments: Arizona Sexual Experience Scale (ASEX) and International Index of Erectile Function. RESULTS: The sample had a mean age of 31.6 (±8) years; the mean duration of BNX treatment was 9 (±4.2) months and the mean BNX dose was 4.5 (±1.6) mg. ASEX showed the prevalence of sexual dysfunction to be 40%. The IIEF demonstrated intercourse dissatisfaction (95%) and hypoactive sexual desire (92.5%) as almost universal, while 77.5% of the participants reported erectile dysfunction. In comparison to the published data, these figures were significantly more than among the controls. We found no correlation of sexual dysfunction with marital status, age, duration or dose of BNX, duration of illicit opioid use, the severity of opioid dependence, and tobacco dependence. CONCLUSION: All men on BNX maintenance therapy must be screened for sexual dysfunction. With the rapid scaling up of office-based BNX substitution, assessment and management of sexual dysfunction ought to be incorporated in the training curriculum.

Informed consent & ethical issues in paediatric psychopharmacology.

Issues relating to informed consent and ethics in paediatric psychopharmacology limit research in this population. Children vary in their levels of cognitive development, and presence of psychiatric disorder may further impair their ability to give informed consent. In decisional impairment subjects, various methods used for consent are assent/dissent; inclusion of advance directives; and/or alternative decision-makers. India is emerging as a new market for clinical trials in recent years. Moreover, in India the sociocultural realities are different from those in the western countries making it necessary for professionals to be cautious in conducting drug trials. In this review, issues regarding informed consent in children and adolescent with psychiatric diagnosis are discussed for information, discussion and debate by professionals, parents, society and legal experts to create awareness and to facilitate development of guidelines that are appropriate and applicable to the Indian system.

Epidemiology of dependence on illicit substances, with a special focus on opioid dependence, in the State of Punjab, India: Results from two different yet complementary survey methods.

BACKGROUND: We used two different yet complementary methods to capture the 'hidden population' of illicit substance users in the state of Punjab, India: Rapid Assessment Survey (RAS) and Punjab Drug Use Monitoring Survey (P-DUMS). METHODOLOGY: For the RAS component, following a pilot study, Respondent Driven Sampling was used to recruit 6600 community-dwelling substance dependent persons aged 11-60 years from all the 22 districts of Punjab. Size was estimated using benchmark-multiplier method, and prevalence was calculated by projecting these data to the source population. For the P-DUMS component, data were collected on 7421 inpatients from 75 government de-addiction centres from 19 districts of Punjab. RESULTS: Subjects In both RAS and P-DUMS were primarily opioid dependent (88% in RAS and 83% in P-DUMS). Heroin (inhaled/injected) emerged as the commonest opioid in both RAS (46%) and P-DUMS (52%), though 30.5% of the RAS sample also used the prescription opioid tramadol. Using the benchmark-multiplier method, 0.27 million (2.5% of the source population) were estimated to be opioid dependent, of which nearly 78,000 (0.7% of the source population) were injecting opioid users (IDUs), predominantly heroin (62%) but also buprenorphine (32.5%). High-risk behaviour was reported by nearly 60% of IDUs. Only 14% of the RAS sample had ever visited any de-addiction centre, and only 2.8% individuals had been admitted to a de-addiction centre in the past year. CONCLUSION: There is a substantive problem of opioid dependence in this difficult-to-reach population of Punjab, with low treatment access. Misuse of prescription opioids along with IDU also raises concern.

Psychosocial impact of dysthymia: a study among married patients.

BACKGROUND: Unlike major depression, the psychosocial impact of dysthymia has received far less research attention. This study attempted to assess the psychosocial consequences of dysthymia. METHODS: The sample consisted of 30 married patients with DSM-IV dysthymic disorder and a matched control group of 30 married patients with recurrent major depressive disorder (RDD), diagnosed using structured interviews. Apart from ratings of severity of depression, assessments of psychosocial impact included quality of life (QOL), disability, perceived social support and marital adjustment. Psychosocial parameters were evaluated using vernacular versions of well-validated scales previously used in similar populations. Matched normal/medically ill controls were derived from Indian studies which had assessed the same parameters using the same instruments. RESULTS: Patients with dysthymia were significantly impaired on measures of QOL, disability, social support and marital adjustment compared to normal/medically ill controls. On the other hand, the two groups of dysthymia and RDD were comparable on these measures apart from significantly lower social support among patients with dysthymia. Duration of illness and severity of depression emerged as the most important correlates, particularly of impaired QOL and disability levels. LIMITATIONS: Small hospital-based sample, normal/medically ill controls derived from other studies and cross-sectional assessments were the major limitations. CONCLUSIONS: Dysthymia had considerable adverse psychosocial impact in terms of QOL, functioning (disability), social support and marital adjustment. Severity and chronicity appeared to be important mediators of this negative psychosocial impact. Increased awareness, improved recognition and adequate treatment might help negate some of the untoward social consequences of this condition.