Are participants in pharmacological and psychotherapy treatment trials for social anxiety disorder representative of patients in real-life settings?

Journal of Clinical Psychopharmacology

Volumn 34, Issue 6, 2014, Pages 697-703

  Hoertel, Nicolas ^a,b,c   De Maricourt, Pierre ^b,c,d   Katz, Julien ^e   Doukhan, Raphaël ^f   Lavaud, Pierre ^a,b   Peyre, Hugo ^f,g   Limosin, Frédéric ^a,b,c  

^a Paris Descartes University   (France)

^b UNIVERSITÉ PARIS DESCARTES   (France)

^c INSERM   (France)

^d CENTRE HOSPITALIER SAINTE ANNE   (France)

^e HENRI MONDOR HOSPITAL   (France)

^f HÔPITAL ROBERT DEBRÉ   (France)

^g CNRS   (France)

Author keywords

Clinical trials; Exclusion criteria; Generalizability; Pharmacotherapy; Psychotherapy; Social anxiety disorder; Social phobia

Indexed keywords

ALCOHOL; PSYCHOTROPIC AGENT;

ADULT; ARTICLE; CLINICAL ASSESSMENT; COMMUNITY SAMPLE; CONTROLLED STUDY; DISEASE ASSOCIATION; DSM-IV; HEALTH SURVEY; HELP SEEKING BEHAVIOR; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MENTAL PATIENT; MULTICENTER STUDY; PATIENT PARTICIPATION; PRIORITY JOURNAL; PSYCHOPHARMACOTHERAPY; PSYCHOTHERAPY; SOCIAL PHOBIA; THERAPY EFFECT; ANXIETY DISORDERS; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; FEMALE; MALE; META ANALYSIS; PATIENT SELECTION; PHOBIC DISORDERS; PROCEDURES; PSYCHOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS; TREATMENT OUTCOME;

ADULT; ANXIETY DISORDERS; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; FEMALE; HEALTH SURVEYS; HUMANS; MALE; PATIENT SELECTION; PHOBIC DISORDERS; PSYCHOTHERAPY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84925643222     PISSN: 02710749     EISSN: 1533712X     Source Type: Journal    
DOI: 10.1097/JCP.0000000000000204     Document Type: Article

References (101)

1. Bucher HC, Guyatt GH, Cook DJ, et al. Users' guides to the medical literature: XIX. Applying clinical trial results. A. How to use an article measuring the effect of an intervention on surrogate end points. Evidence-Based Medicine Working Group. JAMA. 1999;282(8): 771-778.
2. Humphreys K,Weingardt KR, Horst D, et al. Prevalence and predictors of research participant eligibility criteria in alcohol treatment outcome studies, 1970-98. Addiction. 2005;100(9):1249-1257.
3. Humphreys K, Harris AH,Weingardt KR. Subject eligibility criteria can substantially influence the results of alcohol-treatment outcome research. J Stud Alcohol Drugs. 2008;69(5):757-764.
4. Hoertel N, Le Strat Y, Limosin F, et al. Prevalence of subthreshold hypomania and impact on internal validity of RCTs for major depressive disorder: results from a national epidemiological sample. PLoS One. 2013;8(2):e55448.
5. Van Spall HG, Toren A, Kiss A, et al. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297(11):1233-1240.
6. Hoertel N, Falissard B, Humphreys K, et al. Do clinical trials of treatment of alcohol dependence adequately enroll participants with co-occurring independent mood and anxiety disorders? An analysis of data from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). J Clin Psychiatry. 2014;75(3):231-237.
7. Blanco C, Olfson M, Goodwin RD, et al. Generalizability of clinical trial results for major depression to community samples: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2008;69(8):1276-1280.
8. Blanco C, Olfson M, Okuda M, et al. Generalizability of clinical trials for alcohol dependence to community samples. Drug Alcohol Depend. 2008;98(1-2):123-128.
9. Weisberg HI, Hayden VC, Pontes VP. Selection criteria and generalizability within the counterfactual framework: explaining the paradox of antidepressant-induced suicidality? Clin Trials. 2009; 6(2):109-118.
10. March JS, Silva SG, Compton S, et al. The case for practical clinical trials in psychiatry. Am J Psychiatry. 2005;162(5):836-846.
11. Gaynes BN,Warden D, Trivedi MH, et al.What did STAR∗D teach us? Results from a large-scale, practical, clinical trial for patients with depression. Psychiatr Serv. 2009;60(11):1439-1445.
12. Zimmerman M, Chelminski I, Posternak MA. Generalizability of antidepressant efficacy trials: differences between depressed psychiatric outpatients who would or would not qualify for an efficacy trial. Am J Psychiatry. 2005;162(7):1370-1372.
13. Zimmerman M, Mattia JI, Posternak MA. Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? Am J Psychiatry. 2002;159(3):469-473.
14. Boter H, Derks EM, Fleischhacker WW, et al. Generalizability of the results of efficacy trials in first-episode schizophrenia: comparisons between subgroups of participants of the European First Episode Schizophrenia Trial (EUFEST). J Clin Psychiatry. 2010;71(1):58-65.
15. Leucht S, Heres S, Hamann J, et al. Methodological issues in current antipsychotic drug trials. Schizophr Bull. 2008;34(2):275-285.
16. Khan AY, Preskorn SH, Baker B. Effect of study criteria on recruitment and generalizability of the results. J Clin Psychopharmacol. 2005; 25(3):271-275.
17. Hoertel N, Le Strat Y, Lavaud P, et al. Generalizability of clinical trial results for bipolar disorder to community samples: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2013;74(3):265-270.
18. Hoertel N, Le Strat Y, Blanco C, et al. Generalizability of clinical trial results for generalized anxiety disorder to community samples. Depress Anxiety. 2012;29(7):614-620.
19. Hoertel N, Le Strat Y, De Maricourt P, et al. Are subjects in treatment trials of panic disorder representative of patients in routine clinical practice? Results from a national sample. J Affect Disord. 2013;146(3): 383-389.
20. Humphreys K,Weingardt KR, Harris AH. Influence of subject eligibility criteria on compliance with National Institutes of Health guidelines for inclusion of women, minorities, and children in treatment research. Alcohol Clin Exp Res. 2007;31(6):988-995.
21. Okuda M, Hasin DS, Olfson M, et al. Generalizability of clinical trials for cannabis dependence to community samples. Drug Alcohol Depend. 2010;111(1-2):177-181.
22. Le Strat Y, Rehm J, Le Foll B. How generalisable to community samples are clinical trial results for treatment of nicotine dependence: a comparison of common eligibility criteria with respondents of a large representative general population survey. Tob Control. 2011; 20(5):338-343.
23. Grant BF, Hasin DS, Blanco C, et al. The epidemiology of social anxiety disorder in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2005; 66(11):1351-1361.
24. Buckner JD, Heimberg RG, Schneier FR, et al. The relationship between cannabis use disorders and social anxiety disorder in the National Epidemiological Study of Alcohol and Related Conditions (NESARC). Drug Alcohol Depend. 2012;124(1-2):128-134.
25. Moutier CY, Stein MB. The history, epidemiology, and differential diagnosis of social anxiety disorder. J Clin Psychiatry. 1999; 60(suppl 9):4-8.
26. Lydiard RB. Social anxiety disorder: comorbidity and its implications. J Clin Psychiatry. 2001;62(suppl 1):17-23.
27. Manetti A, Hoertel N, Le Strat Y, et al. Comorbidity of late-life depression in the United States: a population-based study. Am J Geriatr Psychiatry. 2014;22:1292-1306.
28. Schuster JP, Hoertel N, Le Strat Y, et al. Personality disorders in older adults: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Am J Geriatr Psychiatry. 2013;21(8): 757-768.
29. Hoertel N, Le Strat Y, Angst J, et al. Subthreshold bipolar disorder in a U.S. national representative sample: prevalence, correlates and perspectives for psychiatric nosography. J Affect Disord. 2013;146(3): 338-347.
30. Fink M, Akimova E, Spindelegger C, et al. Social anxiety disorder: epidemiology, biology and treatment. Psychiatr Danub. 2009;21(4): 533-542.
31. Hoertel N, Crochard A, Rouillon F, et al. Patterns of alcohol consumption in France and their medical and social consequences as seen through the family circle and friends and general practitioners. Encephale. 2014;40(suppl 1):S11-S31.
32. Grant BF, Stinson FS, Dawson DA, et al. Prevalence and co-occurrence of substance use disorders and independent mood and anxiety disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2004;61(8):807-816.
33. Grant BF, Harford TC, Dawson DA, et al. The Alcohol Use Disorder and Associated Disabilities Interview schedule (AUDADIS): reliability of alcohol and drug modules in a general population sample. Drug Alcohol Depend. 1995;39(1):37-44.
34. Grant BF, Dawson DA, Stinson FS, et al. The Alcohol Use Disorder and Associated Disabilities Interview Schedule-IV (AUDADIS-IV): reliability of alcohol consumption, tobacco use, family history of depression and psychiatric diagnostic modules in a general population sample. Drug Alcohol Depend. 2003;71(1):7-16.
35. Grant BF, Dawson DA, Stinson FS, et al. The 12-month prevalence and trends in DSM-IV alcohol abuse and dependence: United States, 1991-1992 and 2001-2002. Drug Alcohol Depend. 2004;74(3): 223-234.
36. Grant BF, Stinson FS, Hasin DS, et al. Prevalence, correlates, and comorbidity of bipolar I disorder and axis I and II disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2005;66(10):1205-1215.
37. Acarturk C, Cuijpers P, van Straten A, et al. Psychological treatment of social anxiety disorder: a meta-analysis. Psychol Med. 2009; 39(2):241-254.
38. de Menezes GB, Coutinho ES, Fontenelle LF, et al. Second-generation antidepressants in social anxiety disorder: meta-analysis of controlled clinical trials. Psychopharmacology (Berl). 2011;215(1):1-11.
39. Stein MB, Fyer AJ, Davidson JR, et al. Fluvoxamine treatment of social phobia (social anxiety disorder): a double-blind, placebo-controlled study. Am J Psychiatry. 1999;156(5):756-760.
40. Baldwin D, Bobes J, Stein DJ, et al. Paroxetine in social phobia/social anxiety disorder. Randomised, double-blind, placebo-controlled study. Paroxetine Study Group. Br J Psychiatry. 1999;175:120-126.
41. Liebowitz MR, Stein MB, Tancer M, et al. A randomized, double-blind, fixed-dose comparison of paroxetine and placebo in the treatment of generalized social anxiety disorder. J Clin Psychiatry. 2002; 63(1):66-74.
42. Lader M, Stender K, Bürger V, et al. Efficacy and tolerability of escitalopram in 12-and 24-week treatment of social anxiety disorder: randomised, double-blind, placebo-controlled, fixed-dose study. Depress Anxiety. 2004;19(4):241-248.
43. Lepola U, Bergtholdt B, St Lambert J, et al. Controlled-release paroxetine in the treatment of patients with social anxiety disorder. J Clin Psychiatry. 2004;65(2):222-229.
44. Pollack MH, Roy-Byrne PP, Van Ameringen M, et al. The selective GABA reuptake inhibitor tiagabine for the treatment of generalized anxiety disorder: results of a placebo-controlled study. J Clin Psychiatry. 2005;66(11):1401-1408.
45. Liebowitz MR, DeMartinis NA, Weihs K, et al. Efficacy of sertraline in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study. J Clin Psychiatry. 2003;64(7):785-792.
46. Montgomery SA, Tobias K, Zornberg GL, et al. 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. 2006;67(5):771-782.
47. Furmark T, Appel L, Michelgard A, et al. Cerebral blood flow changes after treatment of social phobia with the neurokinin-1 antagonist GR205171, citalopram, or placebo. Biol Psychiatry. 2005;58(2):132-142.
48. Stein MB, Pollack MH, Bystritsky A, et al. Efficacy of low and higher dose extended-release venlafaxine in generalized social anxiety disorder: a 6-month randomized controlled trial. Psychopharmacology (Berl). 2005;177(3):280-288.
49. Allgulander C,Mangano R, Zhang J, et al. Efficacy ofVenlafaxine ER in patients with social anxiety disorder: a double-blind, placebo-controlled, parallel-group comparison with paroxetine. Hum Psychopharmacol. 2004;19(6):387-396.
50. Liebowitz MR, Gelenberg AJ, Munjack D. Venlafaxine extended release vs placebo and paroxetine in social anxiety disorder. Arch Gen Psychiatry. 2005;62(2):190-198.
51. Westenberg HG, Stein DJ, Yang H, et al. A double-blind placebo-controlled study of controlled release fluvoxamine for the treatment of generalized social anxiety disorder. J ClinPsychopharmacol. 2004;24(1):49-55.
52. Davidson JR, Bose A,Korotzer A, et al. Escitalopramin the treatment of generalized anxiety disorder: double-blind, placebo controlled, flexible-dose study. Depress Anxiety. 2004;19(4):234-240.
53. Rickels K, Mangano R, Khan A. A double-blind, placebo-controlled study of a flexible dose of venlafaxine ER in adult outpatients with generalized social anxiety disorder. J Clin Psychopharmacol. 2004; 24(5):488-496.
54. Liebowitz MR, Mangano RM, Bradwejn J, et al. A randomized controlled trial of venlafaxine extended release in generalized social anxiety disorder. J Clin Psychiatry. 2005;66(2):238-247.
55. Allgulander C, Dahl AA, Austin C, et al. Efficacy of sertraline in a 12-week trial for generalized anxiety disorder. Am J Psychiatry. 2004;161(9):1642-1649.
56. Katzelnick DJ,Kobak KA, Greist JH, et al. Sertraline for social phobia: a double-blind, placebo-controlled crossover study. Am J Psychiatry. 1995; 152(9):1368-1371.
57. Kobak KA, Greist JH, Jefferson JW, et al. Fluoxetine in social phobia: a double-blind, placebo-controlled pilot study. J Clin Psychopharmacol. 2002;22(3):257-262.
58. Muehlbacher M, Nickel MK, Nickel C, et al. Mirtazapine treatment of social phobia in women: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2005;25(6):580-583.
59. Allgulander C. Paroxetine in social anxiety disorder: a randomized placebo-controlled study. Acta Psychiatr Scand. 1999;100(3): 193-198.
60. Blomhoff S, Haug TT, Hellström K, et al. Randomised controlled general practice trial of sertraline, exposure therapy and combined treatment in generalised social phobia. Br J Psychiatry. 2001;179:23-30.
61. Asakura S, Tajima O, Koyama T. Fluvoxamine treatment of generalized social anxiety disorder in Japan: a randomized double-blind, placebo-controlled study. Int J Neuropsychopharmacol. 2007;10(2): 263-274.
62. Jerremalm A, Jansson L, Ost LG. Cognitive and physiological reactivity and the effects of different behavioral methods in the treatment of social phobia. Behav Res Ther. 1986;24(2):171-180.
63. Gruber K, Moran PJ, Roth W, et al. Computer-assisted cognitive-behavioral group therapy for social phobia. Behav Ther. 2001; 32:155-165.
64. Newman M, Hofmann S, Trabert W, et al. Does behavioral treatment of social phobia lead to cognitive changes? Behav Ther. 1994;25(3): 503-517.
65. Stangier U, Heidenreich T, Peitz M, et al. Cognitive therapy for social phobia: individual versus group treatment. Behav Res Ther. 2003; 41(9):991-1007.
66. Smits JA, Powers MB, Buxkamper R, et al. The efficacy of videotape feedback for enhancing the effects of exposure-based treatment for social anxiety disorder: a controlled investigation. Behav Res Ther. 2006; 44(12):1773-1785.
67. Mörtberg E, Karlsson A, Fyring C, et al. Intensive cognitive-behavioral group treatment (CBGT) of social phobia: a randomized controlled study. J Anxiety Disord. 2006;20(5):646-660.
68. Salaberría K, Echeburúa E. Long-term outcome of cognitive therapy's contribution to self-exposure in vivo to the treatment of generalized social phobia. Behav Modif. 1998;22(3):262-284.
69. Oosterbaan DD, van Balkom AJ, Spinhoven P, et al. Cognitive therapy versus moclobemide in social phobia: a controlled study. Clin Psychol Psychother. 2001;8(4):263-273.
70. Andersson G, Carlbring P, Holmström A, et al. Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial. J Consult Clin Psychol. 2006;74(4): 677-686.
71. Akillas E, Efran J. Symptom prescription and reframing: should they be combined? Cogn Ther Res. 1995;19(3):263-279.
72. Turner SM, Beidel DC, Jacob RG. Social phobia: a comparison of behavior therapy and atenolol. J Consult Clin Psychol. 1994;62(2): 350-358.
73. Stravynski A, Arbel N, Bounader J, et al. Social phobia treated as a problemin social functioning: a controlled comparison of two behavioural group approaches. Acta Psychiatr Scand. 2000;102(3):188-198.
74. Mörtberg E, Clark DM, Sundin O, et al. Intensive group cognitive treatment and individual cognitive therapy vs. treatment as usual in social phobia: a randomized controlled trial. Acta Psychiatr Scand. 2007;115(2): 142-154.
75. Heimberg RG, Liebowitz MR, Hope DA, et al. Cognitive behavioral group therapy vs phenelzine therapy for social phobia: 12-week outcome. Arch Gen Psychiatry. 1998;55(12):1133-1141.
76. Hofmann SG. Cognitive mediation of treatment change in social phobia. J Consult Clin Psychol. 2004;72(3):393-399.
77. Mersch PP. The treatment of social phobia: the differential effectiveness of exposure in vivo and an integration of exposure in vivo, rational emotive therapy and social skills training. Behav Res Ther. 1995;33(3): 259-269.
78. Butler G, Cullington A, Munby M, et al. Exposure and anxiety management in the treatment of social phobia. J Consult Clin Psychol. 1984;52(4):642-650.
79. Clark DM, Ehlers A, Hackmann A, et al. Cognitive therapy versus exposure and applied relaxation in social phobia: a randomized controlled trial. J Consult Clin Psychol. 2006;74(3):568-578.
80. Schelver SR, Gutsch KU. The effects of self-administered cognitive therapy on social-evaluative anxiety. J Clin Psychol. 1983;39(5): 658-666.
81. Mattick RP, Peters L, Clarke JC. Exposure and cognitive restructuring for social phobia: a controlled study. Behav Ther. 1989;20:3-23.
82. Kanter NJ, Goldfried MR. Relative effectiveness of rational restructuring and self-control desensitization in the reduction of interpersonal anxiety. Behav Ther. 1979;10:472-490.
83. Haynes-Clements LA, Avery AW. A cognitive-behavioral approach to social skills training with shy persons. J Clin Psychol. 1984; 40(3):710-713.
84. Harve AG, Clark DM, Ehlers A, et al. Social anxiety and self-impression: cognitive preparation enhances the beneficial effects of video feedback following a stressful social task. Behav Res Ther. 2000;38(12): 1183-1192.
85. Cunningham V, Lefkoe M, Sechrest L. Eliminating fears: an intervention that permanently eliminates the fear of public speaking. Clin Psychol Psychother. 2006;13:183-193.
86. Ayres J, Ayres FE, Baker AL, et al. Two empirical tests of a videotape designed to reduce public speaking anxiety. J Appl Commun Res. 1993;21:132-147.
87. Fremouw WJ, Zitter RE. A comparison of skills training and cognitive restructuring-relaxation for the treatment of speech anxiety. Behav Ther. 1978;9:248-259.
88. Goldenberg IM, White K, Yonkers K, et al. The infrequency of "pure culture" diagnoses among the anxiety disorders. J Clin Psychiatry. 1996;57(11):528-533.
89. Collins JF, Sather MR. Regulatory issues for clinical trials in humans. Epidemiol Rev. 2002;24(1):59-66.
90. Robinson D, Woerner M, Schooler N. Intervention research in psychosis: issues related to clinical assessment. Schizophr Bull. 2000;26(3):551-556.
91. Olfson M, Marcus SC. Decline in placebo-controlled trial results suggests new directions for comparative effectiveness research. Health Aff (Millwood). 2013;32(6):1116-1125.
92. Cohen P, Cohen J. The clinician's illusion. Arch Gen Psychiatry. 1984;41(12):1178-1182.
93. Kirchner JE, Booth BM, Owen RR, et al. Predictors of patient entry into alcohol treatment after initial diagnosis. J Behav Health Serv Res. 2000;27(3):339-346.
94. Olfson M,Marcus SC. National trends in outpatient psychotherapy. Am J Psychiatry. 2010;167(12):1456-1463.
95. Verdoux H, Bégaud B. Pharmaco-epidemiology: what do (and don't) we know about utilisation and impact of psychotropic medications in real-life conditions? Br J Psychiatry. 2004;185:93-94.
96. Melberg HO, Humphreys K. Ineligibility and refusal to participate in randomised trials of treatments for drug dependence. Drug Alcohol Rev. 2010;29(2):193-201.
97. Mavissakalian MR, Guo S. Predictors of entering a long-term drug treatment study of panic disorder. Compr Psychiatry. 2002; 43(2):88-94.
98. Humphreys K, Maisel NC, Blodgett JC, et al. Extent and reporting of patient nonenrollment in influential randomized clinical trials, 2002 to 2010. JAMA Intern Med. 2013;173(11):1029-1031.
99. Hoertel N, de Maricourt P, Gorwood P. Novel routes to bipolar disorder drug discovery. Expert Opin Drug Discov. 2013;8(8): 907-918.
100. Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?" Lancet. 2005;365(9453): 82-93.
101. Geddes JR. Large simple trials in psychiatry: providing reliable answers to important clinical questions. Epidemiol Psichiatr Soc. 2005;14(3): 122-126.