Early onset anxiolytic efficacy after a single dose of pregabalin: Double-blind, placebo- and active-comparator controlled evaluation using a dental anxiety model

Journal of Psychopharmacology

Volumn 23, Issue 8, 2009, Pages 867-873

  Nutt, D ^a   Mandel, F ^b   Baldinetti, F ^b  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b PFIZER INC   (United States)

Author keywords

Alprazolam; Anti anxiety drugs; Anxiety; Benzodiazepines; Pregabalin

Indexed keywords

ALPRAZOLAM; PLACEBO; PREGABALIN;

ABNORMAL SENSATION; ADULT; ANXIETY DISORDER; ARTICLE; ATTENTION DISTURBANCE; BALANCE DISORDER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DENTAL ANXIETY; DENTAL CARE; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MODEL; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCORING SYSTEM; SINGLE DRUG DOSE; SOMNOLENCE; TRANQUILIZING ACTIVITY; VISUAL ANALOG SCALE;

ADULT; ALPRAZOLAM; ANTI-ANXIETY AGENTS; ANXIETY; DOUBLE-BLIND METHOD; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; MALE; MIDDLE AGED; PAIN MEASUREMENT;

EID: 70449336366     PISSN: 02698811     EISSN: 14617285     Source Type: Journal    
DOI: 10.1177/0269881108094722     Document Type: Article

References (26)

1. Ballenger, JC, Davidson, JR, Lecrubier, Y., Nutt, DJ, Borkovec, TD, Rickels, K., et al. (2001) Consensus statement on generalized anxiety disorder from the International Consensus Group on Depression and Anxiety. J Clin Psychiatry 62 (Suppl. 11). 53-58. (Pubitemid 32537578)
2. Berthold, CW, Dionne, RA, Corey, SE (1997) Comparison of sublingually and orally administered triazolam for premedication before oral surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 84: 119-124.
3. Berthold, CW, Schneider, A., Dionne, RA (1993) Using triazolam to reduce dental anxiety. J Am Dent Assoc 124: 58-64.
4. Beydoun, A, Uthman, BM, Kugler, AR, Greiner, MJ, Knapp, LE, Garofalo, EA; Pregabalin 1008-009 Study Group (2005) Safety and efficacy of two pregabalin regimens for add-on treatment of partial epilepsy. Neurology 64: 475-480.
5. Bockbrader, HN, Hunt, T., Strand, JC, Posvar, EL, Sedman, A. (2000) Pregabalin pharmacokinetics and safety in healthy volunteers: results from two phase 1 studies. Neurology 54 (Suppl. 3). A421.
6. Busch, JA, Strand, JC, Posvar, EL, Bockbrader, HN, Radulovic, LL (1998) Pregabalin (CI-1008) single-dose pharmacokinetics and safety/tolerance in healthy subjects after oral administration of pregabalin solution or capsule doses. [abstract 2.108]. Epilepsia 39 (Suppl. 6). 58.
7. Corah, NL (1969) Development of a dental anxiety scale. J Dent Res 48: 596.
8. Crofford, LJ, Rowbotham, MC, Mease, PJ, Russell, IJ, Dworkin, RH, Corbin, AE, et al., Pregabalin 1008-105 Study Group (2005) Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 52: 1264-1273.
9. Dooley, DJ, Taylor, CP, Donevan, S., Feltner, D. (2007) Ca(2+) channel alpha(2)delta ligands: novel modulators of neurotransmission. Trends Pharmacol Sci 28: 75-82.
10. French, JA, Kugler, AR, Robbins, JL, Knapp, LE, Garofalo, EA (2003) Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology 60: 1631-1637.
11. Freynhagen, R., Strojek, K., Griesing, T., Whalen, E., Balkenohl, M. (2005) Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain 115: 254-263.
12. Garzone, PD, Kroboth, PD (1989) Pharmacokinetics of the newer benzodiazepines. Clin Pharmacokinet 16: 337-364.
13. Greenblatt, DJ (2006) Pharmacologic management of dental anxiety: conscious versus unconscious sedation. J Clin Psychopharmacol 26: 1-3.
14. Greenblatt, DJ, Sethy, VH (1990) Benzodiazepine concentrations in brain directly reflect receptor occupancy: studies of diazepam, lorazepam, and oxazepam. Psychopharmacology (Berl) 102: 373-378.
15. Hill, CM, Balkenohl, M., Thomas, DW, Walker, R., Mathe, H., Murray, G. (2001) Pregabalin in patients with postoperative dental pain. Eur J Pain 5: 119-124.
16. IMS (2005) Dataview data on market share of anxiolytic medication for third quarter. Norwalk, CT: IMS Health.
17. Lesser, H., Sharma, U., LaMoreaux, L., Poole, RM (2004) Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology 63: 2104-2110. (Pubitemid 39636259)
18. Montgomery, SA (2006) Pregabalin for the treatment of generalised anxiety disorder. Expert Opin Pharmacother 7: 2139-2154.
19. Montgomery, SA, Tobias, K., Zornberg, GL, Kasper, S., Pande, AC (2006) Efficacy and safety of pregabalin in the treatment of generalized anxiety disorder: a 6-week, multicenter, randomized, double-blind, placebo-controlled comparison of pregabalin and venlafaxine. J Clin Psychiatry 67: 771-782.
20. Pohl, RB, Feltner, DE, Fieve, RR, Pande, AC (2005) Efficacy of pregabalin in the treatment of generalized anxiety disorder: double-blind, placebo-controlled comparison of BID versus TID dosing. J Clin Psychopharmacol 25: 151-158.
21. Rickels, K., Pollack, MH, Feltner, DE, Lydiard, RB, Zimbroff, DL, Bielski, RJ, et al. (2005) Pregabalin for treatment of generalized anxiety disorder: a 4-week, multicenter, double-blind, placebo-controlled trial of pregabalin and alprazolam. Arch Gen Psychiatry 62: 1022-1030.
22. Sheehan, DV, Raj, AB, Harnett-Sheehan, K., Dorotheo, J., Sheehan, MF, Trehan, R., et al. (1996) Method for assessing the duration of therapeutic action and milligram equivalence of anxiolytics. Anxiety 2: 40-46.
23. Wilner, KD, Anziano, RJ, Johnson, AC, Miceli, JJ, Fricke, JR, Titus, CK (2002) The anxiolytic effect of the novel antipsychotic ziprasidone compared with diazepam in subjects anxious before dental surgery. J Clin Psychopharmacol 22: 206-210.
24. Vasile, RG, Bruce, SE, Goisman, RM, Pagano, M., Keller, MB (2005) Results of a naturalistic longitudinal study of benzodiazepine and SSRI use in the treatment of generalized anxiety disorder and social phobia. Depress Anxiety 22: 59-67.
25. Venkatakrishnan, K., Culm, KE, Ehrenberg, BL, Harmatz, JS, Corbett, KE, Fleishaker, JC, et al. (2005) Kinetics and dynamics of intravenous adinazolam, N-desmethyl adinazolam, and alprazolam in healthy volunteers. J Clin Pharmacol 45: 529-537.
26. Von Moltke, LL, Greenblatt, DJ, Harmatz, JS, Shader, RI (1993) Alprazolam metabolism in vitro: studies of man, monkey, mouse and rat liver microsomes. Pharmacology 47: 268-276.