Adjunctive lisdexamfetamine in bipolar depression: A preliminary randomized, placebo-controlled trial

International Clinical Psychopharmacology

Volumn 30, Issue 1, 2015, Pages 6-13

  McElroy, Susan L ^a,b   Martens, Brian E ^a,b   Mori, Nicole ^a,b   Blom, Thomas J ^a,b   Casuto, Leah S ^a   Hawkins, John M ^a   Keck, Paul E ^a,b  

^a N Shore Long Isl Jewish Hlth S   (United States)

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

Author keywords

Bipolar disorder; Lisdexamfetamine; Psychostimulants

Indexed keywords

CHOLESTEROL; LISDEXAMFETAMINE; LOW DENSITY LIPOPROTEIN; MOOD STABILIZER; PLACEBO; TRIACYLGLYCEROL; CENTRAL STIMULANT AGENT; DEXAMPHETAMINE; NEUROLEPTIC AGENT; TRANQUILIZER;

ADULT; ANXIETY; ARTICLE; BINGE EATING DISORDER; BIPOLAR DEPRESSION; BIPOLAR I DISORDER; BIPOLAR II DISORDER; CHOLESTEROL BLOOD LEVEL; CLINICAL ARTICLE; CONTROLLED STUDY; DAYTIME SOMNOLENCE; DECREASED APPETITE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EMOTION; FEMALE; FEVER; FOLLOW UP; GASTROENTERITIS; HEADACHE; HEART PALPITATION; HUMAN; INSOMNIA; IRRITABILITY; JITTERY FEELING; LIPOPROTEIN BLOOD LEVEL; LONGITUDINAL STUDY; MALE; MIGRAINE; MONTGOMERY ASBERG DEPRESSION RATING SCALE; NAUSEA; OUTPATIENT; PREMATURITY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SIDE EFFECT; SINUS CONGESTION; STREPTOCOCCAL PHARYNGITIS; TREMOR; TRIACYLGLYCEROL BLOOD LEVEL; UPPER RESPIRATORY TRACT INFECTION; XEROSTOMIA; BIPOLAR DISORDER; DRUG COMBINATION; MIDDLE AGED; PSYCHOLOGICAL RATING SCALE; PSYCHOLOGY; TIME; TREATMENT OUTCOME; UNITED STATES;

ADULT; ANTIMANIC AGENTS; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; CENTRAL NERVOUS SYSTEM STIMULANTS; DEXTROAMPHETAMINE; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; OHIO; PROSPECTIVE STUDIES; PSYCHIATRIC STATUS RATING SCALES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84918510775     PISSN: 02681315     EISSN: 14735857     Source Type: Journal    
DOI: 10.1097/YIC.0000000000000051     Document Type: Article

References (39)

1. American Psychiatric Association (2000). Diagnostic and statistical manual of mental disorders-text revision. 4 ed.Washington, DC: American Psychiatric Association.
2. Adida M Azorin JM (2014), Effectiveness of methylphenidate as augmentation therapy after failure of adjunctive neuromodulation for patients with treatme ntrefractory bipolar depression: a case report, Neuropsychiatr Dis Treat, 10, 559-562.
3. Anand A, Barkay G, Dzemidzic M, Albrecht D, Karne H, Zheng QH, et al. (2011). Striatal dopamine transporter a vailability in unmedicated bipolar disorder. Bipolar Disord 13:406-413.
4. Bannet J, Ebstein RP, Belmaker RH (1980). Clinical aspects of the interaction of lithium and stimulants. Br J Psychiatry 136:204.
5. Calabrese JR, Ketter TA, Youakim JM, Tiller JM, Yang R, Frye MA (2010). Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder: a randomized, multicenter, double-blind, placebo-controlled, proofof-concept study. J Clin Psychiatry 71:1363-1370.
6. Carlson PJ, Merlock MC, Suppes T (2004). Adjunctive stimulant use in patients with bipolar disorder: treatment of residual depression and sedation. Bipolar Disord 6:416-420.
7. Davidoff E, Reifenstein EC (1939). The results of eighteen months of Benzedrine sulfate therapy in psychiatry. Arch Gen Psychiatry 95:945-969.
8. Dell'Osso B, K etter TA, Cremaschi L, Spagnolin G, Altamura AC (2013). Assessing the roles of stimulants/stimulant-like drugs and dopamine-agonists in the treatment of bipolar depression. Curr Psychiatry Rep 15:378.
9. Drimmer EJ, Gitlin MJ, Gwirtsman HE (1983). Desipramine and methylphenidate combination treatment for depression: case report. Am J Psychiatry 140:241-242.
10. El-Mallakh RS (2000). An open st udy of methylphenidate in bipolar depression. Bipolar Disord 2:56-59.
11. Fawcett J, Kravitz HM, Zajecka JM, Schaff MR (1991). CNS stimulant potentiation of monoamine oxidase inhibitors in treatment-refract ory depression. J Clin Psychopharmacol 11:127-132.
12. Findling RL, Short EJ, McNamara NK, Demeter CA, Stansbrey RJ, Gracious BL, et al. (2007). Methylphenidate in the treatment of children and adolescents with bipolar disorder and attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 46:1445-1453.
13. First MB, Spitzer RL, Gibbon M, JBW Williams (2002). Structured clinical interview for DSM-IV-TR axis I disorders, research version, patient edition with psychotic screen (SCID-I/P W/PSY SCREEN). New York, NY: Biometric Research; New York State Psychiatric Institute.
14. Fitzmaurice GM, Laird NM, Ware J H (2004). Applied longitudinal analysis. Hoboken, NJ: John Wiley & Sons.
15. Frye MA, Grunze H, Suppes T, McElroy SL, Keck PE Jr, Walden J, et al. (2007). A placebo-controlled evaluation o f adjunctive modafinil in the treatment of bipolar depression. Am J Psychiatry 164:1242-1249.
16. Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, et al. (1993). Some conc eptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of Depression Collaborative Research Program dataset. Arch Gen Psychiatry 50: 739-750.
17. Goldberg JF, Burdick K E, Endick CJ (2004). Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. Am J Psychiatry 161:564-566.
18. Gormally J, Black S, Daston S, Rardin D (1982). The assessment of binge eating severity among obese persons. Addict Behav 7:47-55.
19. Hutson PH, Pennick M, Secker R (2014). Preclinical pharmacokinetics, pharmacology and toxicology of lisdexamfetamine: a novel D-amphetamine pro-drug. Neuropharmacology pii: S0028-3908:00078-1.
20. Johns MW (1991 ). A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep 14:540-545.
21. Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD (1989). The fatigue severity scale. Applicatio n to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 46:1121-1123.
22. Lydon E, El-Mallakh RS (2006). Naturalistic long-term use of methylphenidate in bipolar disorder. J Clin Psychopharmacol 26:516-518.
23. Mah L, Zarate CA Jr, Nugent AC, Singh JB, Manji HK, DrevetsWC (2011). Neural mechanisms of antidepressant efficacy of the dopamine receptor agonist pramipexole in treatment of bipolar de pression. Int J Neuropsychopharmacol 14:545-551.
24. McElroy SL,Keck PE Jr (2014), Metabolic syndrome in bipolar disorder: a review with a focus on bipolar depression, J Clin Psychiatry, 75, 46-61.
25. McIntyre RS, Alsuwaidan M, Soczynska JK, Szpindel I, Bilkey TS, Almagor D, et al. (2013). The effect of lisdexamfetamine dimesylate on body weight, metabolic parameters, and attention deficit hyperactivity disorder symptomatology in adults with bipolar I/II disorder. Hum Psychopharmacol 28:421-427.
26. Meyers B (1978). Treatment of imipramine-resistant depression and lithiumrefractory mania through drug interactions. Am J Psychiatry 135:1420-1421.
27. Montgomery SA, Asberg M (1979). A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389.
28. Posner K, Oquendo MA, Gould M, Stanley B, Davies M (2007). Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry 164:1035-1 043.
29. Rush AJ, Gullion CM, Basco MR, Jarrett RB, Trivedi MH (1996). The Inventory of Depressive Symptomatology (IDS): psychometric properties. Psychol Med 26:477-486.
30. Salvadore G, Quiroz JA, Machado-Vieira R, Henter ID, Manji HK, Zarate CA Jr (2010). The neurobiology of the switch process in bipolar disorder: a review. J Clin Psychiatry 71:1488-1501.
31. Schaller JL, Behar D (1998). Treatment of a case of comorbid bipolar disorder and attention-deficit/hyperactivity disorder. J Neuropsychiatry Clin Neurosci 10:235-236.
32. Scheffer RE, Kowatch RA, Carmody T, Rush AJ (2005). Randomized, placebocontrolled trial of mixed amphetamine salts for symptoms of comorbid ADHD in pediatric bipolar disorder after mood stabilization with divalproex sodium. Am J Psychiatry 162:58-64.
33. Shire (2014). Shire Reports top-line results from two phase 3 studies for vyvanse (lisdexamfetamine dimesylate) capsules (CII) as an adjunctive treatment for adults with major depressive disorder. Available at: http://www.sh ire.com/shireplc/en/media/shirenews?id =921 [Accessed 6 February 2014].
34. Spearing MK, Post RM, Leverich GS, Brandt D, Nolen W (1997). Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar ill ness (BP): the CGI-BP. Psychiatry Res 73:159-171.
35. Steer C, Froelich J, Soutullo CA, Johnson M, Shaw M (2012). Lisdexamfetamine dimesylate: a new therapeutic option for attention-deficit hyperactivity di sorder. CNS Drugs 26:691-705.
36. White MA,Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG (2002). Development and validation of the food-craving inventory. Obes Res 10:107-114. Willner P (1995). Dopaminergic mechanisms in depression and mania. In: Bloom FE, Kupfer DJ, editors. Psychopharmacology. The fourth generation of progress. New York: Raven Press, 921-931.
37. Wingo AP, Ghae mi SN (2008). Frequency of stimulant treatment and of stimulantassociated mania/hypomania in bipolar disorder patients. Psychopharmacol Bull 41:37-47.
38. Young RC, Biggs JT, Ziegler VE, Meyer DA (1978). A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 133:429-435.
39. Zarate CA Jr, Payne JL, Singh J, Quiroz JA, Luckenbaugh DA, Denicoff KD, et al. (2004). P ramipexole for bipolar II depression: a placebo-controlled proof of concept study. Biol Psychiatry 56:54-60.