Adjunctive lisdexamfetamine dimesylate therapy in adult outpatients with predominant negative symptoms of schizophrenia: Open-label and randomized-withdrawal phases

Neuropsychopharmacology

Volumn 38, Issue 11, 2013, Pages 2140-2149

  Lasser, Robert A ^a   Dirks, Bryan ^a   Nasrallah, Henry ^b   Kirsch, Courtney ^a   Gao, Joseph ^a   Pucci, Michael L ^c   Knesevich, Mary A ^d   Lindenmayer, Jean Pierre ^e  

^a SHIRE   (United States)

^b UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^c SCI Scientific Communications and Information   (United States)

^d University Hills Clinical Research   (United States)

^e NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Adjunctive; Lisdexamfetamine dimesylate; Negative symptoms; Schizophrenia

Indexed keywords

LISDEXAMFETAMINE; PLACEBO;

ADULT; ARTICLE; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG INDUCED HEADACHE; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEGATIVE SYNDROME; OUTPATIENT CARE; POSITIVE AND NEGATIVE SYNDROME SCALE; POSITIVE SYNDROME; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; XEROSTOMIA;

ADULT; ANTIPSYCHOTIC AGENTS; DEXTROAMPHETAMINE; DOPAMINE AGONISTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; OUTPATIENTS; SCHIZOPHRENIA;

EID: 84884288999     PISSN: 0893133X     EISSN: 1740634X     Source Type: Journal    
DOI: 10.1038/npp.2013.111     Document Type: Article

References (37)

1. Addington D, Addington J, Schissel B (1990). A depression rating scale for schizophrenics. Schizophr Res 3: 247-251.
2. Adler LA, Goodman DW, Kollins SH, Weisler RH, Krishnan S, Zhang Y et al (2008). Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry 69: 1364-1373.
3. American Psychiatric Association (2000). Diagnostic criteria for schizophrenia. In: Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR, 4th edn, Text Revision. American Psychiatric Association: Washington, DC, pp 312-313.
4. Andreasen NC (1984): Scale for the Assessment of Negative Symptoms (SANS). http://www.movementdisorders.org/User- Files/file/Long-SANS-2000- publish%281%29.pdf. Accessed 23 March 2012.
5. Angrist B, Peselow E, Rubinstein M, Corwin J, Rotrosen J (1982). Partial improvement in negative schizophrenic symptoms after amphetamine. Psychopharmacology (Berl) 78: 128-130.
6. Barnes TR (1989). A rating scale for drug-induced akathisia. Br J Psychiatry 154: 672-676.
7. Brams M, Weisler R, Findling R, Gasior M, Hamdani M, Ferreira- Cornwell C et al (2011). Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design. Poster presented at American Psychiatric Association's 164th Annual Meeting. 14- 18 May 2011; Honolulu, HI.
8. Buckley PF, Stahl SM (2007). Pharmacological treatment of negative symptoms of schizophrenia: therapeutic opportunity or cul-de-sac? Acta Psychiatr Scand 115: 93-100.
9. Cesarec Z, Nyman AK (1985). Differential response to amphetamine in schizophrenia. Acta Psychiatr Scand 71: 523-538.
10. Chiarello RJ, Cole JO (1987). The use of psychostimulants in general psychiatry. A reconsideration. Arch Gen Psychiatry 44: 286-295.
11. Curran C, Byrappa N, McBride A (2004). Stimulant psychosis: systematic review. Br J Psychiatry 185: 196-204.
12. Desai NG, Gangadhar BN, Pradhan N, Channabasavanna SM (1984). Treatment of negative schizophrenia with d-amphetamine. Am J Psychiatry 141: 723-724.
13. Dirks B, Lasser R, Nasrallah H, Kirsch C, Adeyi B, Scheckner B et al (2012). Effect of adding lisdexamfetamine dimesylate to antipsychotics on Predominant Negative Symptoms of Schizophrenia: Analysis of PANSS Factors. Poster presented at American Psychiatric Association's 165th Annual Meeting; 5-9 May 2012; Philadelphia, PA.
14. Ermer J, Homolka R, Martin P, Buckwalter M, Purkayastha J, Roesch B (2010). Lisdexamfetamine dimesylate: linear doseproportionality, low intersubject and intrasubject variability, and safety in an open-label single-dose pharmacokinetic study in healthy adult volunteers. J Clin Pharmacol 50: 1001-1010.
15. Foussias G, Remington G (2010). Negative symptoms in schizophrenia: avolition and Occam's razor. Schizophr Bull 36: 359-369.
16. Geodon (package insert) Pfizer: New York, NY; 2010.
17. Guillin O, Abi-Dargham A, Laruelle M (2007). Neurobiology of dopamine in schizophrenia. Int Rev Neurobiol 78: 1-39.
18. Guy W (1976). ECDEU Assessment Manual for Psychopharmacology, Revised. Pub. No. (ADM) 76-338, NIMHUS Department of Health, Education and Welfare: Rockville, MD.
19. Kay SR, Fiszbein A, Opler LA (1987). The Positive and Negative Syndrome Scale (PANSS) for Schizophrenia. Schizophr Bull 13: 261-276.
20. Kirkpatrick B, Fenton WS, Carpenter WTJ, Marder SR (2006). The NIMH-MATRICS consensus statement on negative symptoms. Schizophr Bull 32: 214-219.
21. Laruelle M, Abi-Dargham A, Gil R, Kegeles L, Innis R (1999). Increased dopamine transmission in schizophrenia: relationship to illness phases. Biol Psychiatry 46: 56-72.
22. Laruelle M, Frankle WG, Narendran R, Kegeles LS, Abi-Dargham A (2005). Mechanism of action of antipsychotic drugs: from dopamine D(2) receptor antagonism to glutamate NMDA facilitation. Clin Ther 27(Suppl A): S16-S24.
23. Laughren T, Levin R (2011). Food and Drug Administration commentary on methodological issues in negative symptom trials. Schizophr Bull 37: 255-256.
24. Leucht S, Barnes TR, Kissling W, Engel RR, Correll C, Kane JM (2003). Relapse prevention in schizophrenia with new-generation antipsychotics: a systematic review and exploratory metaanalysis of randomized, controlled trials. Am J Psychiatry 160: 1209-1222.
25. Lieberman JA, Kane JM, Alvir J (1987). Provocative tests with psychostimulant drugs in schizophrenia. Psychopharmacology (Berl) 91: 415-433.
26. Marder SR, Davis JM, Chouinard G (1997). The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin Psychiatry 58: 538-546.
27. McGregor C, Srisurapanont M, Mitchell A, Longo MC, Cahill S, White JM (2008). Psychometric evaluation of the Amphetamine Cessation Symptom Assessment. J Subst Abuse Treat 34: 443-449.
28. Milev P, Ho BC, Arndt S, Andreasen NC (2005). Predictive values of neurocognition and negative symptoms on functional outcome in schizophrenia: a longitudinal first-episode study with 7-year follow-up. Am J Psychiatry 162: 495-506.
29. Olie JP, Spina E, Murray S, Yang R (2006). Ziprasidone and amisulpride effectively treat negative symptoms of schizophrenia: results of a 12-week, double-blind study. Int Clin Psychopharmacol 21: 143-151.
30. Paulson PE, Camp DM, Robinson TE (1991). Time course of transient behavioral depression and persistent behavioral sensitization in relation to regional brain monoamine concentrations during amphetamine withdrawal in rats. Psychopharmacology (Berl) 103: 480-492.
31. Rowley H, Heal D, Hackett D (2011). Simultaneous measurement with hysteresis analyses of the effects of lisdexamfetamine dimesylate and d-amphetamine on striatal levels of extracellular dopamine, locomotor activity, and plasma drug concentrations in freely-moving rats. Poster presented at: New Clinical Drug Evaluation Unit Annual Meeting; 13-16 June 2011; Boca Raton, FL.
32. Simpson GM, Angus JW (1970). A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 212: 11-19.
33. Stahl SM, Buckley PF (2007). Negative symptoms of schizophrenia: a problem that will not go away. Acta Psychiatr Scand 115: 4-11.
34. Storosum JG, Elferink AJ, van Zwieten BJ, van Strik R, Hoogendijk WJ, Broekmans AW (2002). Amisulpride: is there a treatment for negative symptoms in schizophrenia patients? Schizophr Bull 28: 193-201.
35. Tamminga CA (2006). The neurobiology of cognition in schizophrenia. J Clin Psychiatry 67(Suppl 9): 9-13.
36. Toda M, Abi-Dargham A (2007). Dopamine hypothesis of schizophrenia: making sense of it all. Curr Psychiatry Rep 9: 329-336.
37. Vyvanse (package insert). Shire US: Wayne, PA; 2012.