Publications

Recent scientific articles authored by members of Apex’s Scientific Affairs and Clinical Development team:

Cohen, E. A., Skubiak, T., Hadzi Boskovic, D., et al. (2022). Phase 3b multicenter, prospective, open-label trial to evaluate the effects of a digital medicine system on inpatient psychiatric hospitalization rates for adults with schizophrenia. The journal of clinical psychiatry, 83(3), 21m14132. https://doi.org/10.4088/JCP.21m14132

Najarian, D., Sanga, P., Wang, S., Lim, P., Singh, A., Robertson, M. J., Cohen, K., Schotte, A., Milz, R., Venkatasubramanian, R., T’Jollyn, H., Walling, D. P., Galderisi, S., & Gopal, S. (2021). A randomized, double-blind, multicenter, noninferiority study comparing paliperidone palmitate 6-month versus the 3-month long-acting injectable in patients with schizophrenia. The international journal of neuropsychopharmacology, pyab071. Advance online publication. https://doi.org/10.1093/ijnp/pyab071

Walling, D. P., Hassman, H. A., Anta, L., Ochoa, L., Ayani, I., Martínez, J., & Gutierro, I. (2021). The Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM and Oral Risperidone: An Open-Label, One-Sequence Study. Drug design, development and therapy15, 4371–4382. https://doi.org/10.2147/DDDT.S332026

Nasrallah, H. A., Weiden, P. J., Walling, D. P., Du, Y., Yao, B., Yagoda, S., & Claxton, A. (2021). Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. BMC psychiatry21(1), 492. https://doi.org/10.1186/s12888-021-03420-x

Le Moigne, A., Csernansky, J., Leadbetter, R. A., Andorn, A. C., Graham, J. A., Heath, A. T., Walling, D. P., Newcomer, J. W., & Marder, S. R. (2021). PANSS Individual Item and Marder Dimension Analyses From a Pivotal Trial of RBP-7000 (Monthly Extended-Release Risperidone) in Schizophrenia Patients. The Journal of clinical psychiatry82(5), 21m13906. https://doi.org/10.4088/JCP.21m13906

Miller, D. S., Robert, P., Ereshefsky, L., Adler, L., Bateman, D., Cummings, J., DeKosky, S. T., Fischer, C. E., Husain, M., Ismail, Z., Jaeger, J., Lerner, A. J., Li, A., Lyketsos, C. G., Manera, V., Mintzer, J., Moebius, H. J., Mortby, M., Meulien, D., Pollentier, S., … Lanctôt, K. L. (2021). Diagnostic criteria for apathy in neurocognitive disorders. Alzheimer’s & dementia : the journal of the Alzheimer’s Association17(12), 1892–1904. https://doi.org/10.1002/alz.12358

Fleischhacker, W. W., Podhorna, J., Gröschl, M., Hake, S., Zhao, Y., Huang, S., Keefe, R., Desch, M., Brenner, R., Walling, D. P., Mantero-Atienza, E., Nakagome, K., & Pollentier, S. (2021). Efficacy and safety of the novel glycine transporter inhibitor BI 425809 once daily in patients with schizophrenia: a double-blind, randomised, placebo-controlled phase 2 study. The lancet. Psychiatry8(3), 191–201. https://doi.org/10.1016/S2215-0366(20)30513-7

Yacyshyn, B.R., Hanauer, S., Klassen, P., English, B.A., Stauber, K., Barish, C.F., Gilder, K., Turner, S., Higgins, P. (2021). Safety, Pharmacokinetics, and Efficacy of Olorinab, a Peripherally Acting, Highly Selective, Full Agonist of the Cannabinoid Receptor 2, in a Phase 2a Study of Patients With Chronic Abdominal Pain Associated With Crohn’s Disease, Crohn’s & Colitis 360, 3(1). https://doi.org/10.1093/crocol/otaa089

Citrome, L., Walling, D. P., Zeni, C. M., Starling, B. R., Terahara, T., Kuriki, M., Park, A. S., & Komaroff, M. (2020). Efficacy and Safety of HP-3070, an Asenapine Transdermal System, in Patients With Schizophrenia: A Phase 3, Randomized, Placebo-Controlled Study. The Journal of clinical psychiatry82(1), 20m13602. https://doi.org/10.4088/JCP.20m13602

Atsou, K., Ereshefsky, L., Brignone, M., Danchenko, N., Diamand, F., Mucha, L., Touya, M., Becker, R., & François, C. (2021). Cost-effectiveness of vortioxetine compared with levomilnacipran and vilazodone in patients with major depressive disorder switching from an initial antidepressant. Expert review of pharmacoeconomics & outcomes research21(1), 29–42. https://doi.org/10.1080/14737167.2021.1855979

Cohen, E. A., Hassman, H. H., Ereshefsky, L., Walling, D. P., Grindell, V. M., Keefe, R., Wyka, K., & Horan, W. P. (2021). Placebo response mitigation with a participant-focused psychoeducational procedure: a randomized, single-blind, all placebo study in major depressive and psychotic disorders. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology46(4), 844–850. https://doi.org/10.1038/s41386-020-00911-5

O’Gorman, C., Khoury, R., Anderson, A., Carter, M., DiCesare, F., Dubé, S., Ereshefsky, L., Grossberg, G., Hefting, N., Khan, S., Lind, S., Moebius, H., Shiovitz, T., & Rosenberg, P. (2020). A Framework for Developing Pharmacotherapy for Agitation in Alzheimer’s Disease: Recommendations of the ISCTM* Working Group. The journal of prevention of Alzheimer’s disease7(4), 274–282. https://doi.org/10.14283/jpad.2020.37

Weiden, P. J., Claxton, A., Kunovac, J., Walling, D. P., Du, Y., Yao, B., Yagoda, S., Bidollari, I., Keane, E., & Cash, E. (2020). Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. The Journal of clinical psychiatry81(3), 19m13207. https://doi.org/10.4088/JCP.19m13207

Goenjian, A. K., Steinberg, A. M., Walling, D., Bishop, S., Karayan, I., & Pynoos, R. (2021). 25-year follow-up of treated and not-treated adolescents after the Spitak earthquake: course and predictors of PTSD and depression-ERRATUM. Psychological medicine51(6), 989–990. https://doi.org/10.1017/S0033291720001348

Goenjian, A. K., Steinberg, A. M., Walling, D., Bishop, S., Karayan, I., & Pynoos, R. (2021). 25-year follow-up of treated and not-treated adolescents after the Spitak earthquake: course and predictors of PTSD and depression. Psychological medicine51(6), 976–988. https://doi.org/10.1017/S0033291719003891

Walling, D. P., Banerjee, A., Dawra, V., Boyer, S., Schmidt, C. J., & DeMartinis, N. (2019). Phosphodiesterase 10A Inhibitor Monotherapy Is Not an Effective Treatment of Acute Schizophrenia. Journal of clinical psychopharmacology39(6), 575–582. https://doi.org/10.1097/JCP.0000000000001128

Hard, M. L., Wehr, A., von Moltke, L., Du, Y., Farwick, S., Walling, D. P., & Sonnenberg, J. (2019). Pharmacokinetics and safety of deltoid or gluteal injection of aripiprazole lauroxil NanoCrystal® Dispersion used for initiation of the long-acting antipsychotic aripiprazole lauroxil. Therapeutic advances in psychopharmacology9, 2045125319859964. https://doi.org/10.1177/2045125319859964

DeMartinis, N., 3rd, Lopez, R. N., Pickering, E. H., Schmidt, C. J., Gertsik, L., Walling, D. P., & Ogden, A. (2019). A Proof-of-Concept Study Evaluating the Phosphodiesterase 10A Inhibitor PF-02545920 in the Adjunctive Treatment of Suboptimally Controlled Symptoms of Schizophrenia. Journal of clinical psychopharmacology39(4), 318–328. https://doi.org/10.1097/JCP.0000000000001047

Hard, M. L., Wehr, A. Y., Du, Y., Weiden, P. J., Walling, D., & von Moltke, L. (2018). Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia. Journal of clinical psychopharmacology38(5), 435–441. https://doi.org/10.1097/JCP.0000000000000921

Jankovic, J., Goodman, I., Safirstein, B., Marmon, T. K., Schenk, D. B., Koller, M., Zago, W., Ness, D. K., Griffith, S. G., Grundman, M., Soto, J., Ostrowitzki, S., Boess, F. G., Martin-Facklam, M., Quinn, J. F., Isaacson, S. H., Omidvar, O., Ellenbogen, A., & Kinney, G. G. (2018). Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA neurology75(10), 1206–1214. https://doi.org/10.1001/jamaneurol.2018.1487

Brown, D., Nakagome, K., Cordes, J., Brenner, R., Gründer, G., Keefe, R., Riesenberg, R., Walling, D. P., Daniels, K., Wang, L., McGinniss, J., & Sand, M. (2019). Evaluation of the Efficacy, Safety, and Tolerability of BI 409306, a Novel Phosphodiesterase 9 Inhibitor, in Cognitive Impairment in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. Schizophrenia bulletin45(2), 350–359. https://doi.org/10.1093/schbul/sby049

Saal, H. J., Heerinckx, F., Zawadzki, R., Omidvar, O., Kilpatrick, M., & Zesiewicz, T. (2018). Strong correlations among four measures of disease progression in Friedreich’s ataxia. Movement disorders : official journal of the Movement Disorder Society33(6), 1021–1022. https://doi.org/10.1002/mds.27351

Zesiewicz, T., Heerinckx, F., De Jager, R., Omidvar, O., Kilpatrick, M., Shaw, J., & Shchepinov, M. S. (2018). Randomized, clinical trial of RT001: Early signals of efficacy in Friedreich’s ataxia. Movement disorders : official journal of the Movement Disorder Society33(6), 1000–1005. https://doi.org/10.1002/mds.27353

Goenjian, A. K., Khachadourian, V., Armenian, H., Demirchyan, A., & Steinberg, A. M. (2018). Posttraumatic Stress Disorder 23 Years After the 1988 Spitak Earthquake in Armenia. Journal of traumatic stress31(1), 47–56. https://doi.org/10.1002/jts.22260

Carmichael, O., Schwarz, A. J., Chatham, C. H., Scott, D., Turner, J. A., Upadhyay, J., Coimbra, A., Goodman, J. A., Baumgartner, R., English, B. A., Apolzan, J. W., Shankapal, P., & Hawkins, K. R. (2018). The role of fMRI in drug development. Drug discovery today23(2), 333–348. https://doi.org/10.1016/j.drudis.2017.11.012

Fu, D. J., Turkoz, I., Walling, D., Lindenmayer, J. P., Schooler, N. R., & Alphs, L. (2018). Paliperidone palmitate once-monthly maintains improvement in functioning domains of the Personal and Social Performance scale compared with placebo in subjects with schizoaffective disorder. Schizophrenia research192, 185–193. https://doi.org/10.1016/j.schres.2017.04.004

Bain, E. E., Shafner, L., Walling, D. P., Othman, A. A., Chuang-Stein, C., Hinkle, J., & Hanina, A. (2017). Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia. JMIR mHealth and uHealth5(2), e18. https://doi.org/10.2196/mhealth.7030