Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: A randomized, double-blind study

Annals of Clinical Psychiatry

Volumn 25, Issue 4, 2013, Pages

  Khan, Arifulla ^a,b   Atkinson, Sarah ^c   Mezhebovsky, Irina ^d   She, Fahua ^e   Leathers, Todd ^e   Pathak, Sanjeev ^e  

^a Northwest Clinical Research Center   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Finger Lakes Clinical Research   (United States)

^d Boston Clinical Trials Inc   (United States)

^e ASTRAZENECA   (United Kingdom)

Author keywords

Antipsychotics; Anxiety disorders; Clinical trial; Phase 3; Sustained release preparations; Treatment efficacy

Indexed keywords

CHLORAL HYDRATE; CHOLINERGIC RECEPTOR BLOCKING AGENT; DULOXETINE; ESCITALOPRAM; PAROXETINE; PLACEBO; QUETIAPINE; SEROTONIN NORADRENALIN REUPTAKE INHIBITOR; SEROTONIN UPTAKE INHIBITOR; VENLAFAXINE; ZALEPLON; ZOLPIDEM TARTRATE; ZOPICLONE;

ADJUVANT THERAPY; ADULT; AGED; AKATHISIA; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EJACULATION DISORDER; EXTRAPYRAMIDAL SYMPTOM; FEMALE; GENERALIZED ANXIETY DISORDER; HAMILTON ANXIETY SCALE; HEADACHE; HUMAN; HYPERACTIVITY; INSOMNIA; LETHARGY; LIBIDO DISORDER; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MEDICATION COMPLIANCE; PATIENT COMPLIANCE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REDUCTION; REMISSION; RESTLESSNESS; SEDATION; SIDE EFFECT; SOMNOLENCE; SUICIDAL BEHAVIOR; SUICIDAL IDEATION; TREATMENT RESPONSE; TREMOR; XEROSTOMIA;

ADULT; ANTIPSYCHOTIC AGENTS; ANXIETY DISORDERS; DELAYED-ACTION PREPARATIONS; DIBENZOTHIAZEPINES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG SYNERGISM; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; NEUROTRANSMITTER UPTAKE INHIBITORS; NOREPINEPHRINE; PSYCHIATRIC STATUS RATING SCALES; SEROTONIN UPTAKE INHIBITORS; TREATMENT OUTCOME;

EID: 84899814465     PISSN: 10401237     EISSN: 15473325     Source Type: Journal    
DOI: None     Document Type: Article

References (49)

1. Bruce SE, Yonkers KA, Otto MW, et al. Influence of psychiatric comorbidity on recovery and recurrence in generalized anxiety disorder, social phobia, and panic disorder: a 12-year prospective study. Am J Psychiatry. 2005;162:1179-1187. (Pubitemid 40770702)
2. Pollack MH. Refractory generalized anxiety disorder. J Clin Psychiatry. 2009;70(suppl 2):32-38.
3. Wittchen HU. Generalized anxiety disorder: prevalence, burden, and cost to society. Depress Anxiety. 2002;16:162-171.
4. Baldwin DS, Anderson IM, Nutt DJ, et al. Evidence-based guidelines for the pharmacological treatment of anxiety disorders: recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2005;19:567-596. (Pubitemid 41578819)
5. Bandelow B, Zohar J, Hollander E, et al; WFSBP Task Force on Treatment Guidelines for Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and post-traumatic stress disorders - first revision. World J Biol Psychiatry. 2008;9:248-312.
6. Canadian Psychiatric Association. Management of anxiety disorders. Can J Psychiatry. 2006;51(8 suppl 2):1S-93S.
7. NICE guidelines. Anxiety: management of anxiety (panic disorder, with or without agoraphobia, and generalised anxiety disorder) in adults in primary, secondary and community care. http://www.nice.org.uk/CG022NICEguidelines. Accessed April 1,2010.
8. Rickels K, Rynn M, Iyengar M, et al. Remission of generalized anxiety disorder: a review of the paroxetine clinical trials database. J Clin Psychiatry. 2006;67:41-47. (Pubitemid 43213281)
9. Montgomery SA, Sheehan DV, Meoni P, et al. Characterization of the longitudinal course of improvement in generalized anxiety disorder during longterm treatment with venlafaxine XR. J Psychiatr Res. 2002;36:209-217. (Pubitemid 34626371)
10. Katzman MA, Vermani M, Jacobs L, et al. Quetiapine as an adjunctive pharmacotherapy for the treatment of non-remitting generalized anxiety disorder: a flexible-dose, open-label pilot trial. J Anxiety Disord. 2008;22:1480-1486.
11. Lohoff FW, Etemad B, Mandos LA, et al. Ziprasidone treatment of refractory generalized anxiety disorder: a placebo-controlled, double-blind study. J Clin Psychopharmacol. 2010;30:185-189.
12. Bandelow B, Chouinard G, Bobes J, et al. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010;13:305-320.
13. Khan A, Joyce M, Atkinson S, et al. A randomized, double-blind study of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalized anxiety disorder. J Clin Psychopharmacol. 2011;31:418-428.
14. Merideth C, Cutler AJ, She F, et al. Efficacy and tolerability of extended release quetiapine fumarate monotherapy in the acute treatment of generalized anxiety disorder: a randomized, placebo-controlled and active-controlled study. Int Clin Psychopharmacol. 2012;27:40-54.
15. Mezhebovsky I, Magi K, She F, et al. Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder. Int J Geriatr Psychiatry. 2013;28:615-625.
16. Katzman MA, Brawman-Mintzer O, Reyes EB, et al. Extended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder: a long-term, randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2011;26:11-24.
17. AstraZeneca. Seroquel XR: summary of product characteristics (Ireland). http://www.medicines.ie/ medicine/13032/SPC/Seroquel+XR+50mg%2c+150 mg%2c+200mg%2c+300mg%2c+400mg+prolonged-release+ tablets. Updated August 30, 2013. Accessed September 6, 2013.
18. Seroquel [package insert]. Wilmington, DE: AstraZeneca; 2013.
19. Diagnostic and statistical manual of mental disorders, 4th edition. Washington, DC: American Psychiatric Association; 1994.
20. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(suppl 20):22-33. (Pubitemid 29001829)
21. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32:50-55.
22. Guy W. Clinical Global Impressions. In: ECDEU Assessment Manual for Psychopharmacology. Washington, DC: US Department of Health, Education and Welfare; 1976:218-222.
23. Endicott J, Nee J, Harrison W, et al. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29:321-326. (Pubitemid 23311543)
24. Posner K, Oquendo MA, Gould M, et al. 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. 2007;164:1035-1043. (Pubitemid 47121392)
25. Simpson GM, Angus JWS. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl. 1970;212:11-19.
26. Barnes TR. A rating scale for drug-induced akathisia. Br J Psychiatry. 1989;154:672-676. (Pubitemid 19154942)
27. Rosenbaum JF, Fava M, Hoog SL, et al. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol Psychiatry. 1998;44:77-87. (Pubitemid 28305526)
28. Michelson D, Fava M, Amsterdam J, et al. Interruption of selective serotonin reuptake inhibitor treatment. Double-blind, placebo-controlled trial. Br J Psychiatry. 2000;176:363-368.
29. Hommel G. A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika. 1988;75:383-386.
30. Pinson L, Gray GE. Psychopharmacology: number needed to treat: an underused measure of treatment effect. Psychiatr Serv. 2003;54:145-146,154.
31. Rynn MA, Brawman-Mintzer O. Generalized anxiety disorder: acute and chronic treatment. CNS Spectr. 2004;9:716-723. (Pubitemid 39473441)
32. Khan A, Khan S, Brown WA. Are placebo controls necessary to test new antidepressants and anxiolytics? Int J Neuropsychopharmacol. 2002;5:193-197.
33. Fava M, Evins AE, Dorer DJ, et al. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom. 2003;72:115-127. (Pubitemid 36469860)
34. Katz MM, Halbreich UM, Bowden CL, et al. Enhancing the technology of clinical trials and the trials model to evaluate newly developed, targeted antidepressants. Neuropsychopharmacology. 2002; 27:319-328. (Pubitemid 35253781)
35. Brawman-Mintzer O, Knapp RG, Nietert PJ. Adjunctive risperidone in generalized anxiety disorder: a double-blind, placebo-controlled study. J Clin Psychiatry. 2005;66:1321-1325. (Pubitemid 41546513)
36. Lydiard RB, Rickels K, Herman B, et al. Comparative efficacy of pregabalin and benzodiazepines in treating the psychic and somatic symptoms of generalized anxiety disorder. Int J Neuropsychopharmacol. 2010; 13:229-241.
37. Bauer M, Pretorius HW, Constant EL, et al. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double- blind study. J Clin Psychiatry. 2009;70:540-549.
38. Bortnick B, El-Khalili N, Banov M, et al. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in major depressive disorder: a placebo-controlled, randomized study. J Affect Disord. 2011;128:83-94.
39. Cutler AJ, Montgomery SA, Feifel D, et al. Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine- controlled study. J Clin Psychiatry. 2009;70:526-539.
40. El-Khalili N, Joyce M, Atkinson S, et al. Extended- release quetiapine fumarate (quetiapine XR) as adjunctive therapy in major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant treatment: a multicentre, randomized, double-blind, placebo-controlled study. Int J Neuropsychopharmacol. 2010;13:917-932.
41. Weisler R, Joyce M, McGill L, et al. Extended release quetiapine fumarate monotherapy for major depressive disorder: results of a double-blind, randomized, placebo-controlled study. CNS Spectr. 2009; 14:299-313.
42. Purdon SE, Malla A, Labelle A, et al. Neuropsychological change in patients with schizophrenia after treatment with quetiapine or haloperidol. J Psychiatry Neurosci. 2001;26:137-149. (Pubitemid 32373127)
43. Liebowitz M, Lam RW, Lepola U, et al. Efficacy and tolerability of extended release quetiapine fumarate monotherapy as maintenance treatment of major depressive disorder: a randomized, placebo-controlled trial. Depress Anxiety. 2010;27:964-976.
44. Nyberg S, Widzowski D. Translational pharmacology of quetiapine and norquetiapine: preclinical findings support multifunctional psychotropic properties. Eur Psychiatry. 2010;25(suppl 1):1446.
45. Jensen NH, Rodriguiz RM, Caron MG, et al. N-desalkylquetiapine, a potent norepinephrine reuptake inhibitor and partial 5-HT(1A) agonist, as a putative mediator of quetiapine's antidepressant activity. Neuropsychopharmacology. 2008;33:2303-2312.
46. Owens MJ, Krulewicz S, Simon JS, et al. Estimates of serotonin and norepinephrine transporter inhibition in depressed patients treated with paroxetine or venlafaxine. Neuropsychopharmacology. 2008;33: 3201-3212.
47. Arvanitis LA, Miller BG. Multiple fixed doses of "Seroquel" (quetiapine) in patients with acute exacerbation of schizophrenia: a comparison with haloperidol and placebo. The Seroquel Trial 13 Study Group. Biol Psychiatry. 1997;42:233-246. (Pubitemid 27325811)
48. Kahn RS, Schulz SC, Palazov VD, et al. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007;68:832-842. (Pubitemid 47015481)
49. Timdahl K, Carlsson A, Stening G. An analysis of safety and tolerability data from controlled, comparative studies of quetiapine in patients with schizophrenia, focusing on extrapyramidal symptoms. Hum Psychopharmacol. 2007;22:315-325. (Pubitemid 47180393)