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`

`310$ BIOL PSYCHIATRY 2008;63:3038—3198
`
`Author Index
`
`Johns, J. M. 281
`Johnson, A. Kim. 115
`Johnson, C. 262
`Johnson, J 22
`Johnson, K. 641
`Johnson, K. A. 443, 510, 647, 932
`Johnson, L. L. 376
`Johnsrone, E. C. 488
`Johnstone, T. 147
`Jokinen, J. 922
`Jollant, F. 923
`Jonak, G. 389
`Jones, E. G. 927
`Jones, H. 561
`Jones, M. 548
`Joober, R. 765, 790, 848, 849, 885
`Josephson, M. 476
`Jovanovic, T. 550
`Joyce, E. M. 152
`Jucaite, A. 321
`Jungerman, F. 55, 56
`Jurjus, G. 653
`Kabir, A. 146
`Kaddurah—Daouk, R. 272, 453
`Kaffenbcrger, T. 162
`Kagedal, M. 321
`Kahn, A. S. 645
`Kahn, J. 477
`Kahn, R. S. 737, 744
`Kaiser, J. 763
`Kalali, A. H. 766
`Kalas, C. 68, 615
`Kalidindi, S. 71
`Kaiin, N. H. 147, 177, 180
`Kalisch, R. 144
`Kalmnr, J. H. 119, 142, 437, 487, 579
`Kaluzhny, P. 690
`Kamath, V. 375, 387
`Kanba, S. 801, 814, 822
`Kane, J. M. 27, 244, 382, 875,911,913
`Kanellopoulou, 1. 804
`Kang, C. 97
`Kang, H. 232
`Kansaku, K. 356
`Kantamneni, A. 84
`Kanrrowitz, J. T. 902
`Kapas, M. 905
`Kaplan, B. B. 150
`Kaplan, J. 534
`Kaprio, J. 81
`Kapur, S. 39, 484, 717,888
`Karayal, O. 898
`Karlsgodt, K. H. 805
`Karlsson, 1’. 321
`Kurlsson, R. 191
`Karmacharya, R. 316
`Karp, J. 575
`Karpf, R. 119
`Knrpyak, V. M. 525
`Karry, R. 256
`Karmn, S. 388, 850
`Kasahara, E. 296, 35
`Kasai, K. 857
`Kasserman, S. 119, 557
`
`www.sobp.org/journal
`
`Kato, T. 419
`Katz, D. A. 39
`Katz, E. R. 725
`Katz, N. S. 317
`Katzman, M. 435
`Kaufman, J. 15
`Kaushik, S. 806, 906
`Kawakubo, Y. 857
`Kawashima, T. 867
`Kaye, W. H. 67, 468, 469, 774
`Kayser, J. 239, 242
`Keefe, R. 363
`Keegan, K. A. 291
`Keenan, T. 390
`Keener, M. T. 171
`Keilp, J. G. 105
`Keller, K. E. 166
`Keller, K. L. 606
`Kelley, M. E. 644
`Kelly, A. 348
`Kelly,A. M. 119, 159, 517
`Kelly, C. 20
`Kelly, C. 947
`Kelly, M. 834
`Kelly, M. P. 17
`Kelly, S. P. 843
`Kelsoe, J. R. 247, 476
`Kern, W. R. 376
`Kema, I. P. 944
`Kemether, E. 897
`Kempf, L. 234, 852
`Kenna, H. 48
`Kennedy, J. L , 51, 503, 727, 861, 864
`Kennedy, 5. E. 353
`Kennedy, S. H.646
`Kennel, C. 363
`Keshavan, M. S. 93, 117, 272, 377,378, 379, 613,
`800, 825
`Kesslcr, R. 33, 230, 682
`Ketter, T. A. 567, 606
`Khadivi, A. 875
`Khairova, R. A. 268
`Khan, A. 806, 811, 906
`Khan, S. 385, 834
`Khan, U. 807
`Khanna, A. 345
`Khine, T. T. 800, 825
`Kicseppfi, T. 81
`Kilts,J. D. 688
`Kim, H. 175
`Kim, J. 525
`Kim, P. 232
`Kim, S. 846
`Kim, Y. 547
`Kimak, M. A. 462, 539
`Kimhy, D. 385, 834
`King, A. P. 551
`King, E. 221, 827
`King, N. 51
`King, S. 848
`King, T. 189
`Kinnally, E. L. 339
`Kinon, 8.]. 888, 889
`Kipp, H. 613
`
`Kippenhan, J. S. 212, 222, 252
`Kirbas, C. 870
`Kirov, G. 383
`Kish, 5.]. 101, 50, 717
`Kjartansson, (3. 52
`Klabunde, M. 468
`Kleber, R. 282
`Klein, C. 357
`Klein, C. R. 49, 170, 605
`Klein, E. 184, 267
`Klein, R. G. 417
`Kleinhaus, K. 407, 853
`Kleinman, J. E. 297, 475
`Klempan, T. A. 259
`Kling, M. A. 329
`Kloiber, S. 250
`Klossika, 1. 401, 403
`Klumpp, H. 544
`Klunder, A. D. 350
`Kmiecik, L. 99
`Knauer, C. S. 269
`Knop, J. 394, 53
`K0, D. 204, 205, 206
`Kobeissy, F. H. 273
`Koch, J. K. 598, 818
`Kochetkova, A. 497
`Koenigsberg, H. W. 145, 413, 414, 473, 505
`Kogan, J. 116
`Kohler, C. G. 386, 785, 787, 809, 868
`Kohn, P. D. 210, 212, 221,227, 252,254,794
`Kohn, P. F. 279
`Kolachana, B. 227, 252, 254, 794, 858
`Kolden, G. P. 147
`Kolivakis, T. 646
`Kollack-Walker, S. 888, 889
`Kollins, S. H. 771
`Kolochana, B. 852
`Kondo, H. 208
`Kondo, T. 802
`Kondziolka, D. 930
`Konradi, C. 576
`Koo, M. 360
`Kopecek, M. 350
`Kopecek, M. 580, 581, 87
`Koran, L. M. 532
`Korf, J. 944
`Korrh, C. 3
`Kose, S. 443, 510, 641, 647
`Kosik—Gonzalez, C. 766, 887
`Koury, M. 1
`Kozaric—Kovacie, D. 550
`Kozel, F. 443, 510
`Krain, A. L. 159
`Kramer, E. 645
`Kramer, M. 908
`Kramer, W. E. 26
`Kraus, M. 363
`Kraut, M. A. 154
`Kreher, D. A. 368
`Kremen, W. S. 497
`Krieg, J. 649
`Krieg, J. C. 444, 628, 649
`Kring, A. M. 837
`Kronfcld—Scor, N. 186
`
`Mylan V. Janssen (IPR2020-00440) EX. 1041, p. 003
`This material wasetapied
`at the N‘LM a nd may be
`Su Inject US GDpryrright Laws
`
`

`

`2885
`
`15101. I’SYCI'IIA’l‘RY 2008;63:15—5018
`
`Saturday Abstracts
`
`Methods: Metabolic and cardiovascular data from 357 chronically ill (38.3 +
`10.05 years old, 251 Male, 70.4% African—American) schizophrenia patients
`who were screened for participation in clinical trials from 1998—2007 (80.2%
`on atypical antipsychotics. 12.3% on typical antipsychotics, 7.5% untreated)
`were compared to a sample of2,531 non—schizophrenic age—matched controls
`from the 2003—2004 Center for Disease Control and Prevention‘s National
`Health and Nutrition Examination Survey (NHANES) on measures
`including fasting blood sugars and lipids, 13M], and blood pressure.
`Results: 29.1% of patients were overweight (15M1>25) and 37.8% were obese
`(BM1>30). Pasting lipids, cholesterol and triglycerides were elevated in 39.3%
`and 40.5% of patients respectively.
`I'llevations in fasting blood sugar (PBS
`>110mg/dl) were found in 16.7% of patients with 7.6% having diabetes (PBS
`>126mg/dl). 15.5% were hypertensive (diastolic liP >8Snthg), and 54.5%
`had abnormal ECGs. 34% had metabolic syndrome (11:189).
`'I‘herc were no
`differences across variables when compared to the age—matched NHANIES
`controls. No association with either typical or atypical nettroleptic treatment
`was found based on X3 tests of differences.
`Conclusions: Lack of differences with recent NHANES control data and
`lack of association with neurolepric therapy suggests that other
`factors
`besides nettroleptic treatment (eg. diet, lifestyle) play a role in metabolic and
`cardiovascular abnormalities found in schizophrenia patients.
`
`908. Efficacy and Tolerability of Paliperidone
`Palmitate: 9-week, Placebo-Controlled Study in
`Schizophrenia Patients
`
`Michelle Kramer‘, Robert E. Litman2, Rosanne Lane‘,
`Pilar Lim‘, David Hough‘, Marielle Eerdekens3
`1Johnson & Johnson Pharmaceutical Research & Development,
`Titusville, NJFCBH Health, LLC, Rockville, MD,3Johnson & Johnson
`Pharmaceutical Research & Development, Beerse, Belgium
`
`Background: '1 'his study evaluated the efficacyand safety ofpal iperidone palmitate,
`a long—acting injectable agent, in the treatment of schizophrenia patients.
`Methods:
`/\ 9—week, double—blind, placebo—controlled study randomized
`patients to placebo or paliperidone palmitate 50 or 100mg eq. on Days 1. 8 and
`36 (without: oral supplementation). Efficacy and tolerability were evaluated via
`changes in mean Positive and Negative Syndrome Scale (PANSS) total scores
`and adverse event (A 1i) reporting, respectively.
`Results: The intention—to—treat popttlation included 197 patients (ntalc:62%,
`meanistandard deviation {SDI age=39..">110.3y; placebo N=66; paliperidone
`palmitate 50 mg eq. N=63; paliperidone palmitat‘e 100 mg eq. N=68).
`Me:\n;tSl) PANSS total scores significantly improved (ps0.0()l) from baseline
`(87.01125) to end point for paliperidone palmitate 50 mg et]. (5.21.215)
`and 100 mg ct].
`(-7.811‘).4) versus placebo (+6.2:t18.3), with significant
`improvements observed from Day 8. Responder rates (230% improvement in
`PANSS total score at end point) were significantly greater in both paliperidone
`palmitate groups verstts placebo (p30.007). Alis occurring 23% more in either
`paliperidone palmitate group versus placebo (safety population, N=247) were
`insomnia,
`schizophrenia,
`restlessness,
`sedation, extrapyrantidal disorder,
`hypertonia, attention disturbance, electrocardiogram abnormal, constipation,
`myalgia, asthenia and vertigo.
`lixtrapyramidal
`symptoms—Alf
`rates were
`comparable for paliperidone palmitate and placebo, with the exception of
`pa rkinsonism (7% and 1%, respectively). Serious Alis in 21 patient (any group)
`were schizophrenia and psychotic disorder.
`injections were generally well
`tolerated. No deaths occurred.
`Conclusions: Paliperidone palmirate (50 and 100 mg eq. doses) is effective and
`well tolerated in acute symptomatic schizophrenia.
`Supported byJohnson 8( Johnson Pharmaceutical Services, 1.1.(,'.., and Johnson
`65c Johnson Pharmaceutical Research 8c Development
`
`909. Pharmacokinetics (PK) of Multiple Doses
`of Olanzapine Long Acting Injection (OLAI), an
`Intramuscular (IM) Depot Formulation of Olanzapine
`(0L2), in Stabilized Patients with Schizophrenia
`
`Darcie Kurtz, Richard Bergstrom, David P. McDonnell,
`Malcolm Mitchell
`
`Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN
`
`Background: Olanzapine pamoate is a long—acting depot formulation of()1.'/.
`that is an effective treatment for patients who benefit from the advantages ofa
`depot. it has not yet been approved.
`Methods: Schizophrenic patients stabilized on daily oral OLZ received multiple
`OLAI injections at doses of 100, 150, 160, 200, and 300 tug/2 weeks attd 200,
`255, 300, and 405 tug/4 weeks for 24 weeks. After each injection, serial plasma
`OLZ concentration samples were collected. PK were characterized using non—
`compartmental methods.
`Results: The injections were well tolerated overall. Absorption—lintited PK \Vcl‘L‘
`observed. Plasma OLZ concentrations were sustained throughout both the 3»
`and 4—week injection intervals. On average, 01.7. concentrations accumulate
`2— to 3-fold upon multiple dosing and reach steady-state conditions after
`about 3 months of dosing. Peak—to—trougb fluctuation in ()LZ concentrations
`averages 51% for the 2—week injection interval and 7‘3% for the 4—week interval.
`Maximum concentration and area under the concentration versus time curve
`for OLZ were proportionate to OLAl dose. Relative to oral OLZ (tum = (1 hr.
`t1” = 29 hr), the time ofpeak concentration following OLAI was 4 days and the
`half—life was approximately 26 days. The average steady—state concentrations
`sustained by OLAI correspond to those maintained by daily OLZ in the dosage
`range of 5—20 nag/day.
`tolerated and provides
`is well
`Conclusions: 1M administration of OLAI
`steady—state concentrations that are sustained over 4 weeks and are comparal‘rle
`to oral treatment.
`
`Supported by Eli Lilly and Company
`
`910. Relapse Prevention: Risperidone Long—Acting
`lnjectable Vs Quetiapine or Aripiprazole
`
`Rossella Medori
`
`Medical Affairs, Janssen—Cilag, Beerse, Belgium
`
`Background: To investigate if risperidone long—acting injectable (Rl./\l‘
`provides better efficacy maintenance over 2 years, as measured by the timt
`to relapse,
`in comparison to the oral atypical antipsychotic qttetiapine tn
`aripiprazole.
`1—year
`randomized.
`Methods: Open—label, active—controlled, multicenter,
`trial of RI.A1 versus oral quetiapine or aripiprazole in 731 patients with
`schizophrenia
`currently treated with oral
`risperidone, olanzapine m
`conventional neuroleptics. Symptomatically stable patients on a stable tin-.e
`of an antipsychotic for 24 weeks were enrolled. Primary efficacy evaluation
`was time to relapse. Secondary efficacy evaluations included: Positive and
`Negative Syndrome Scale (PANSS), Clinical Global
`Impression—Sereriti
`(C(il-S), Montgomery—Asberg Depression Rating Scale (MADRS) and Sotial
`and Occupational Functioning Assessment Scale (SOP/\S). Safety evaluations
`included adverse events monitoring, lixtrapyramidal Symptom Rating Sell;
`(ESRS), clinical laboratory tests and vital signs.
`Results: 808 subjects were screened and 731 (58.3% male, mean age 41:?
`ISD:12.8] years) were randomised to treatment. Mean time since first onset
`was 13.9 (51):] 1.2) years; mean time since first treatment was 12.5 (SD:10."”
`years. At baseline 34.4% of subjects fulfilled the retnission severity criteria.
`Reasons for switching (>1 allowed) included:
`insufficient efficacy: negative
`(29.8%), positive (14.1%), and general symptoms (21.1%) and adverse ewnt~~
`(18.9%). Baseline scores were: PANSS: 73.0 (SD:21.8), CCl-S: 3.7 (Sl):1.0\
`
`www.sobp.org/journal
`
`Mylan V. Janssen (IPR2020-00440) EX. 1041, p. 004
`This material was mpired
`at the N‘LM and maybe
`Su inject U15 IDDpyright Laws
`
`