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7. Natural history and clinical outcomes in patients with Alzheimer's disease–related psychosis by antipsychotic treatment status in the United States.

Author

Rao, Sapna, Forns, Joan, Danysh, Heather E, Calingaert, Brian, Dempsey, Colleen, Aquilina, Thomas, Pathak, Sanjeev, Anthony, Mary S, and Layton, J Bradley

Subjects
ALZHEIMER'S disease, URINARY tract infections, NURSING care facilities, ALZHEIMER'S patients, ANTIPSYCHOTIC agents
Abstract

Background: While some literature on clinical outcomes in persons with dementia-related psychosis exists, little is known regarding Alzheimer's disease–related psychosis (ADP). Objective: Describe demographic/clinical characteristics of adults with ADP and estimate incidence of clinical events by antipsychotic treatment status. Methods: This cohort study identified adults ≥65 years with Alzheimer's disease and incident psychosis (US Medicare database [2013–2018]) and no prior exposure to antipsychotics. Two nonmutually exclusive ADP subcohorts included: patients who initiated treatment with antipsychotic medications (antipsychotic users) and those who remained untreated (antipsychotic nonusers). Baseline characteristics were evaluated before psychosis diagnosis in untreated patients and before antipsychotic initiation in treated patients. Incidence rates were estimated for falls and fractures (composite and separately), seizure/epilepsy (new onset and any), and mortality. Results: 145,333 ADP antipsychotic nonusers and 49,452 antipsychotic users were identified. Both cohorts had similar baseline demographics; however, antipsychotic users versus nonusers had higher baseline skilled nursing facility use (40.3% and 27.8%), mood (72.7% and 62.1%) and anxiety (70.9% and 57.3%) disorders, falls/fractures (39.5% and 33.8%), urinary tract infections (55.1% and 47.0%), and frailty index scores (76.0% and 69.7%). Crude incidence rates (95% confidence interval)/100 person-years in antipsychotic users and nonusers were 70.0 (68.9–71.2) and 55.8 (55.4–56.1) (falls/fractures composite), 69.0 (67.9–70.1) and 54.9 (54.5–55.2) (falls), 38.6 (38.1–39.0) and 33.0 (32.7–33.2) (mortality), and 45.8 (44.9–46.7) and 54.2 (53.9–54.6) (any seizure/epilepsy). Conclusions: Antipsychotic initiators with ADP had a higher burden of some baseline comorbidities; experienced higher incidence of falls, fractures, and mortality; and had lower incidence of seizure/epilepsy than antipsychotic nonusers. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Does Ownership Influence Corporate Social Responsibility (CSR)? A Study Of Post-Csr Law Implementation In India

Author

Pathak, Sanjeev, Tripathy, Arun Kumar, Panda, Abinash, Pathak, Sanjeev, Tripathy, Arun Kumar, and Panda, Abinash

Abstract

Objective: This study examines the influence of different ownership structures on corporate social responsibility spending in a mandatory CSR regime. Method: We use the CSR data under statutory mandate reported by the top 500 publicly listed Indian firms of the first four years after CSR law implementation in 2014 on Bombay Stock Exchange and the Ministry of Corporate Affairs website. Using institutional and agency theory arguments, we hypothesize that ownership structure influences CSR spending. We use multiple logistics regression for our statistical analyses. Results: In line with our prediction, our results reveal that different ownership structures influence the variation in CSR spending. Foreign firms spend on CSR at par with the statutory mandate. Government firms spend above the statutory mandate, and promoter-owned firms spend below the statutory mandate. Conclusion: Through CSR spending on social development initiatives, firms can contribute to the United Nations' sustainable development goals (SDGs) and build their credibility among stakeholders. Our study explains the influence of different ownership structures on CSR spending in a mandatory CSR regime. This study can help policymakers revisit the CSR law provisions by understanding why some firms are spending more and why some firms are spending less on CSR and encourage firms to spend more on CSR initiatives. We leverage institutional and agency theory to explain our findings.

Published
2024

16. Pre-clinical development of oxidative DNA adducts as biomarkers for the chemoprevention of prostate cancer

Author

Pathak, Sanjeev

Subjects
616.99463
Abstract

Reactive oxygen species (ROS) are mechanistically implicated in the development and progression of prostate cancer. Intracellular ROS may cause oxidative DNA damage, resulting in the formation of adducts, such as 8-oxo-7,8-dihydro-2'-deoxyguanosine (8oxo-dG) and the cyclic pyrimidopurinone N-1, N-2 malondialdehyde-2'deoxyguanosine (MidG). These adducts have been associated with carcinogenesis, genomic instability and clonal evolution. It has previously been shown in vitro that testosterone and dihydrotestosterone (DHT) increase ROS levels in the androgensensitive, human prostate cancer cell line, LNCaP.

Published
2008

18. Efficacy and safety of pimavanserin in patients with Alzheimer’s dementia psychosis in the HARMONY phase 3, randomized discontinuation study: a post hoc subgroup analysis

Author

Cummings, Jeffrey, primary, Devanand, Davangere P, additional, Ballard, Clive G, additional, Tariot, Pierre N., additional, Hendrix, Suzanne B., additional, Dickson, Samuel P., additional, Li, Caiyan, additional, Abler, Victor, additional, Pathak, Sanjeev, additional, and Stankovic, Srdjan, additional

Published
2022
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20. The Dysfunctional Attitudes Scale: Psychometric Properties in Depressed Adolescents

Author

Rogers, Gregory M., Park, Jong-Hyo, Essex, Marilyn J., Klein, Marjorie H., Silva, Susan G., Hoyle, Rick H., Curry, John F., Feeny, Norah C., Kennard, Betsy, Kratochvil, Christopher J., Pathak, Sanjeev, Reinecke, Mark A., Rosenberg, David R., Weller, Elizabeth B., and March, John S.

Abstract

The psychometric properties and factor structure of the Dysfunctional Attitudes Scale were examined in a sample of 422 male and female adolescents (ages 12-17) with current major depressive disorder. The scale demonstrated high internal consistency ([alpha] = 0.93) and correlated significantly with self-report and interview-based measures of depression. Confirmatory factor analysis indicated that a correlated 2-factor model, with scales corresponding to perfectionism and need for social approval, provided a satisfactory fit to the data. The goodness-of-fit was equivalent across sexes and age groups. The findings support the use of the Dysfunctional Attitudes Scale and its subscales in the assessment of clinically depressed adolescents. (Contains 4 tables and 1 footnote.)

Published
2009
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30. Runs of homozygosity and testicular cancer risk

Author

Loveday, C, Sud, A, Litchfield, K, Levy, M, Holroyd, A, Broderick, P, Kote-Jarai, Z, Dunning, AM, Muir, K, Peto, J, Eeles, R, Easton, DF, Dudakia, D, Orr, N, Pashayan, N, Rustin, Gordon, Srihari, Narayanan N, Cole, David, Askill, Colin, Bertelli, Gianfilippo, Barber, James, Gilby, Ed, White, Jeff, Baybrooke, Jeremy, Leahy, Michael, Welch, Richard, Chakraborti, Prabir, Joffe, Johnathan, Brown, Richard, Faust, Guy, Simmonds, Peter, Mazhar, Danish, Stockdale, Andrew, Hrounda, David, Humber, Caroline, Appel, Wiebke, Hong, Anne, Howard, Grahame, Douglas, Fiona, Bloomfield, David, Butt, Mohammad, Kelly, Kay, Mehra, Rakesh, Rogers, Paul, Hatton, Matthew, Hennig, Ivo, McAteer, John, Savage, Philip, Seckl, Michael, Gale, Joanna, Clark, Peter, Woby, Steve, Rathmell, Adrian, Lamont, Alan, Sarwar, Naveed, Stuart, Nick, Chowdhury, Simon, Beesley, Sharon, Winkler, Mathius, Hamid, Abdel, Pathak, Sanjeev, Madhavan, Krishnaswamy, Highley, Martin, Money-Kryle, Julian, Brock, Cathryn, Sreenivasan, Thiagarajan, Henderson, Brian E, Haiman, Christopher A, Schumacher, Fredrick R, Al Olama, Ali Amin, Benlloch, Sara, Berndt, Sonja I, Conti, David V, Wiklund, Fredrik, Chanock, Stephen, Gapster, Susan, Stevens, Victoria L, Tangen, Catherine M, Batra, Jyotsna, Clements, Judith, Gronberg, Henrik, Schleutker, Johanna, Albanes, Demetrius, Wolk, Alicja, West, Catharine, Mucci, Lorelei, Cancel-Tassin, Geraldine, Koutros, Stella, Sorensen, Karina Dalsgaard, Maehle, Lovise, Neal, David E, Hamdy, Freddie C, Donovan, Jenny L, Travis, Ruth C, Hamilton, Robert J, Ingles, Sue Ann, Rosenstein, Barry S, Lu, Yong-Jie, Giles, Graham G, Kibel, Adam S, Vega, Ana, Kogevinas, Manolis, Penney, Kathryn L, Park, Jong Y, Stanford, Janet L, Cybulski, Cezary, Nordestgaard, Borge G, Brenner, Hermann, Maier, Christiane, Kim, Jeri, John, Esther M, Teixeira, Manuel R, Neuhausen, Susan L, De Ruyck, Kim, Razack, Azad, Newcomb, Lisa F, Lessel, Davor, Kaneva, Radka, Usmani, Nawaid, Claessens, Frank, Townsend, Paul A, Dominguez, Manuela Gago, Roobol, Monique J, Menegaux, Florence, Khaw, Kay-Tee, Cannon-Albrigh, Lisa, Pandha, Hardev, Thibodeau, Stephen N, Reid, A, Huddart, RA, Houlston, RS, Turnbull, C, and Urology

Subjects
Oncology, Male, Endocrinology, Diabetes and Metabolism, LOCI, Genome-wide association study, Runs of Homozygosity, SUSCEPTIBILITY, VARIANTS, 0302 clinical medicine, Endocrinology, testicular germ cell tumour, Risk Factors, Genotype, genetics, Andrology, 030219 obstetrics & reproductive medicine, Genome, Homozygote, Neoplasms, Germ Cell and Embryonal, Disease gene identification, homozygosity mapping, Life Sciences & Biomedicine, RECENT POSITIVE SELECTION, medicine.medical_specialty, Urology, Biology, BREAST, Polymorphism, Single Nucleotide, 03 medical and health sciences, Endocrinology & Metabolism, Testicular Neoplasms, SDG 3 - Good Health and Well-being, Internal medicine, medicine, Genetic predisposition, cancer, Humans, Allele, GENOME-WIDE ASSOCIATION, SEX DETERMINATION, runs of homozygosity, Science & Technology, IDENTIFICATION, Cancer, recessive, medicine.disease, GERM-CELL TUMOR, CONSANGUINITY, Reproductive Medicine, Relative risk, genome-wide association studies, Genome-Wide Association Study
Abstract

BACKGROUND: Testicular germ cell tumour (TGCT) is highly heritable but > 50% of the genetic risk remains unexplained. Epidemiological observation of greater relative risk to brothers of men with TGCT compared to sons has long alluded to recessively acting TGCT genetic susceptibility factors, but to date none have been reported. Runs of homozygosity (RoH) are a signature indicating underlying recessively acting alleles and have been associated with increased risk of other cancer types. OBJECTIVE: To examine whether RoH are associated with TGCT risk. METHODS: We performed a genome-wide RoH analysis using GWAS data from 3206 TGCT cases and 7422 controls uniformly genotyped using the OncoArray platform. RESULTS: Global measures of homozygosity were not significantly different between cases and controls, and the frequency of individual consensus RoH was not significantly different between cases and controls, after correction for multiple testing. RoH at three regions, 11p13-11p14.3, 5q14.1-5q22.3 and 13q14.11-13q.14.13, were, however, nominally statistically significant at p

Published
2019
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31. SET-C versus fluoxetine in the treatment of childhood social phobia

Author

Beidel, Deborah C., Turner, Samuel M., Ammerman, Robert T., Sallee, Floyd R., Crosby, Lori A., and Pathak, Sanjeev

Subjects
Attention-deficit hyperactivity disorder -- Research, Social phobia -- Care and treatment, Adolescent psychology -- Research, Family and marriage, Psychology and mental health
Abstract

A study examines the effectiveness of fluoxetine, pill placebo and Social Effectiveness Therapy for Children (SET-C) for children and adolescents with social phobia. The results conclude that both fluoxetine and SET-C are effective for social phobia but SET-C is better for enhancing social skills.

Published
2007

32. Research knowledge among the participants in the Treatment for Adolescents With Depression Study (TADS)

Author

Vitiello, Benedetto, Kratochvil, Christopher J., Silva, Susan, Curry, John, Reinecke, Mark, Pathak, Sanjeev, Waslick, Bruce, Hughes, Carroll W., Prentice, Ernest D., May, Diane E., and March, John S.

Subjects
Depression in adolescence -- Patient outcomes, Family and marriage, Psychology and mental health
Abstract

A study examined the extent to which parents and adolescents participating in the Treatment for Adolescents With Depression Study (TADS) understood the study. The results concluded that most were well-informed, and also parents were overall better informed than adolescents.

Published
2007

36. Treatment for adolescents with Depression Study (TADS): safety results

Author

Emslie, Graham, Kratochvil, Christopher, Vitiello, Benedetto, Silva, Susan, Mayes, Taryn, McNulty, Steven, Weller, Elizabeth, Waslick, Bruce, Casat, Charles, Walkup, John, Pathak, Sanjeev, Rohde, Paul, Posner, Kelly, and March, John

Subjects
Depression in adolescence -- Care and treatment, Depression in adolescence -- Diagnosis, Depression in adolescence -- Research, Family and marriage, Psychology and mental health
Published
2006

37. Predictors and moderators of acute outcome in the treatment for adolescents with Depression Study (TADS)

Author

Curry, John, Rohde, Paul, Simons, Anne, Silva, Susan, Vitiello, Benedetto, Kratochvil, Christopher, Reinecke, Mark, Feeny, Norah, Wells, Karen, Pathak, Sanjeev, Weller, Elizabeth, Rosenberg, David, Kennard, Betsy, Robins, Michele, Ginsburg, Golda, and March, John

Subjects
Depression in adolescence -- Care and treatment, Depression in adolescence -- Risk factors, Depression in adolescence -- Patient outcomes, Family and marriage, Psychology and mental health
Published
2006

38. Acute time to response in the treatment for adolescents with Depression Study (TADS)

Author

Kratochvil, Christopher, Emslie, Graham, Silva, Susan, McNulty, Steve, Walkup, John, Curry, John, Reinecke, Mark, Vitiello, Benedetto, Rohde, Paul, Feeny, Nora, Casat, Charles, Pathak, Sanjeev, Weller, Elizabeth, May, Diane, Mayes, Taryn, Robins, Michele, and March, John

Subjects
Depression in adolescence -- Care and treatment, Depression in adolescence -- Research, Family and marriage, Psychology and mental health
Published
2006

39. Functioning and quality of life in the treatment for adolescents with Depression Study (TADS)

Author

Vitiello, Benedetto, Rohde, Paul, Silva, Susan, Wells, Karen, Casat, Charles, Waslick, Bruce, Simons, Anne, Reinecke, Mark, Weller, Elizabeth, Kratochvil, Christopher, Walkup, John, Pathak, Sanjeev, Robins, Michele, and March, John

Subjects
Quality of life -- Research, Depression in adolescence -- Care and treatment, Depression in adolescence -- Research, Family and marriage, Psychology and mental health
Published
2006

40. Remission and residual symptoms after short-term treatment in the treatment of adolescents with Depression Study (TADS)

Author

Kennard, Betsy, Silva, Susan, Vitiello, Benedetto, Curry, John, Kratochvil, Christopher, Simons, Anne, Hughes, Jennifer, Feeny, Norah, Weller, Elizabeth, Sweeney, Michael, Reinecke, Mark, Pathak, Sanjeev, Ginsburg, Golda, Emslie, Graham, and March, John

Subjects
Depression in adolescence -- Care and treatment, Depression in adolescence -- Diagnosis, Depression in adolescence -- Research, Family and marriage, Psychology and mental health
Published
2006

46. An exploratory analysis of the impact of family functioning on treatment for depression in adolescents

Author

Feeny, Norah C., Silva, Susan G., Reinecke, Mark A., McNulty, Steven, Findling, Robert L., Rohde, Paul, Curry, John F., Ginsburg, Golda S., Kratochvil, Christopher J., Pathak, Sanjeev M., May, Diane E., Kennard, Betsy D., Simons, Anne D., Wells, Karen C., Robins, Michele, Rosenberg, David, and March, John S.

Subjects
Depression in adolescence -- Care and treatment, Depression in adolescence -- Social aspects, Parent and child -- Psychological aspects, Psychology and mental health
Published
2009

50. Buprenorphine/samidorphan combination for the adjunctive treatment of major depressive disorder: results of a phase III clinical trial (FORWARD-3)

Author

Zajecka,John M, Stanford,Arielle D, Memisoglu,Asli, Martin,William F, and Pathak,Sanjeev

Subjects
Neuropsychiatric Disease and Treatment
Abstract

John M Zajecka,1,2 Arielle D Stanford,3 Asli Memisoglu,4 William F Martin,5 Sanjeev Pathak3 1Department of Psychiatry, Rush University Medical Center, Chicago, IL, USA; 2Psychiatric Medicine Associates, LLC, Skokie, IL, USA; 3Department of Clinical Research, Alkermes, Inc., Waltham, MA, USA; 4Department of Biostatistics, Alkermes, Inc., Waltham, MA, USA; 5Clinical Operations, Alkermes, Inc., Waltham, MA, USA Background: The endogenous opioid system is a fundamental regulator of mood in humans. Previously reported clinical trials have demonstrated the efficacy of the investigational agent buprenorphine/samidorphan (BUP/SAM) combination, an opioid-system modulator, for the adjunctive treatment of major depressive disorder. We present here a third phase III study of different design. Methods: Adult patients with major depressive disorder and inadequate response to antidepressant therapy were enrolled in this double-blind, placebo-controlled, placebo run-in study to evaluate the efficacy, safety, and tolerability of adjunctive BUP/SAM 2 mg/2 mg. Patients with baseline Hamilton Depression Rating Scale score ≥20 received double-blind placebo in addition to background antidepressant therapy for 4 weeks. Nonresponders were randomized to receive adjunctive BUP/SAM 2 mg/2 mg or placebo for 6 weeks. The primary end point was change in Montgomery–Åsberg Depression Rating Scale (MADRS)-10 total score from randomization at baseline to the end of the 6-week treatment period.Results: Least-squares mean change in MADRS-10 score at end of treatment was -4.8 (SE 0.67) in the BUP/SAM 2 mg/2 mg group and -4.6 (SE 0.66) in the placebo group (mean difference -0.3 [SE 0.95], P=0.782). There were no differences in MADRS-based response or remission rates. Overall, 42.9% of the BUP/SAM 2 mg/2 mg group and 34.5% of the placebo group experienced at least one treatment-emergent adverse event during the 6-week treatment period, most of which were mild or moderate in severity. There were no clinically important changes in laboratory parameters, weight, or vital signs and no evidence of abuse potential during treatment or opiate-withdrawal symptoms post treatment.Conclusion: Efficacy results in FORWARD-3 measured by change in MADRS-10 score did not meet the primary end point, but postbaseline improvement in MADRS-10 in the BUP/SAM 2 mg/2 mg group was consistent with that seen in previously reported trials. BUP/SAM 2 mg/2 mg was well tolerated. Keywords: buprenorphine, samidorphan, randomized clinical trial, adjunctive therapy, study design, placebo response, opioid system modulator &nbsp

Published
2019

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