Download PDF
Pharmacopsychiatry 2010; 43(6): 205-209
DOI: 10.1055/s-0030-1254091
Review

© Georg Thieme Verlag KG Stuttgart · New York

Trials Assessing Parmacotherapeutic Management of Aggression in Psychiatric Patients: Comparability with Clinical Practice

L. E. Goedhard1 , 2 , J. J. Stolker2 , 3 , H. L. I. Nijman1 , 4 , T. C. G. Egberts2 , 5 , E. R. Heerdink1 , 2 , 5
  • 1Altrecht Institute for Mental Health Care, Den Dolder, The Netherlands
  • 2Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht, The Netherlands
  • 3Arkin Institute for Mental Health Care, Amsterdam, the Netherlands
  • 4Academic Center of Social Sciences, Radboud University Nijmegen, The Netherlands
  • 5Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands
Further Information

Publication History

received 05.07.2009 revised 05.01.2010

accepted 08.03.2010

Publication Date:
29 June 2010 (online)

Also available at
    Permissions and Reprints

Abstract

Introduction: In a previous review of randomized controlled trials (RCTs) on the pharmacotherapeutic management of aggression, it was shown that there is only weak evidence of effectiveness. In the present study we aim to determine comparability of patients included in these RCTs and patients of psychiatric long-stay wards.

Methods: Exclusion criteria that were used in at least 20% of the RCTs were applied to a sample of aggressive inpatients from clinical practice, in order to find what proportion of these patients would be eligible to participate in the reviewed, high quality RCTs.

Results: Only 30% of aggressive psychiatric patients as seen in clinical practice would be eligible to participate in a typical randomized controlled trial based on the most frequently applied exclusion criteria.

Discussion: The low comparability of patients included in RCTs with those seen in clinical practice may decrease the generalizability of the findings form RCTs to clinical practice.

References

  • 1 Allan ER, Alpert M, Sison CE. et al . Adjunctive nadolol in the treatment of acutely aggressive schizophrenic patients.  J Clin Psychiatry. 1996;  57 455-459
    CrossrefPubMedGoogle Scholar
  • 2 Alpert M, Allan ER, Citrome L. et al . A double-blind, placebo-controlled study of adjunctive nadolol in the management of violent psychiatric patients.  Psychopharmacol Bull. 1990;  26 367-371
    PubMedGoogle Scholar
  • 3 Blin O, Azorin JM, Bouhours P. Antipsychotic and anxiolytic properties of risperidone, haloperidol, and methotrimeprazine in schizophrenic patients.  J Clin Psychopharmacol. 1996;  16 38-44
    CrossrefPubMedGoogle Scholar
  • 4 Caldwell A. Hospital accountability: perceptions and costs.  Front Health Serv Manage. 1992;  8 38-40
    PubMedGoogle Scholar
  • 5 Caspi N, Modai I, Barak P. et al . Pindolol augmentation in aggressive schizophrenic patients: a double-blind crossover randomized study.  Int Clin Psychopharmacol. 2001;  16 111-115
    CrossrefPubMedGoogle Scholar
  • 6 Citrome L, Casey DE, Daniel DG. et al . Adjunctive divalproex and hostility among patients with schizophrenia receiving olanzapine or risperidone.  Psychiatr Serv. 2004;  55 290-294
    CrossrefPubMedGoogle Scholar
  • 7 Citrome L, Volavka J, Czobor P. et al . Effects of clozapine, olanzapine, risperidone, and haloperidol on hostility among patients with schizophrenia.  Psychiatr Serv. 2001;  52 1510-1514
    CrossrefPubMedGoogle Scholar
  • 8 Coccaro EF, Kavoussi RJ. Fluoxetine and impulsive aggressive behavior in personality-disordered subjects.  Arch Gen Psychiatry. 1997;  54 1081-1088
    PubMedGoogle Scholar
  • 9 Czobor P, Volavka J, Meibach RC. Effect of risperidone on hostility in schizophrenia.  J Clin Psychopharmacol. 1995;  15 243-249
    CrossrefPubMedGoogle Scholar
  • 10 Davidson JR, McLeod MN, Turnbull CD. et al . A comparison of phenelzine and imipramine in depressed inpatients.  J Clin Psychiatry. 1981;  42 395-397
    PubMedGoogle Scholar
  • 11 Davidson JR, Landerman LR, Farfel GM. et al . Characterizing the effects of sertraline in post-traumatic stress disorder.  Psychol Med. 2002;  32 661-670
    PubMedGoogle Scholar
  • 12 de la Fuente JM, Lotstra F. A trial of carbamazepine in borderline personality disorder.  Eur Neuropsychopharmacol. 1994;  4 479-486
    CrossrefPubMedGoogle Scholar
  • 13 Dorrego MF, Canevaro L, Kuzis G. et al . A randomized, double-blind, crossover study of methylphenidate and lithium in adults with attention-deficit/hyperactivity disorder: preliminary findings.  J Neuropsychiatry Clin Neurosci. 2002;  14 289-295
    CrossrefPubMedGoogle Scholar
  • 14 Edlund MJ, Craig TJ, Richardson MA. Informed consent as a form of volunteer bias.  Am J Psychiatry. 1985;  142 624-627
    PubMedGoogle Scholar
  • 15 Fassino S, Leombruni P, Daga G. et al . Efficacy of citalopram in anorexia nervosa: a pilot study.  Eur Neuropsychopharmacol. 2002;  12 453-459
    PubMedGoogle Scholar
  • 16 Fava M, Nierenberg AA, Quitkin FM. et al . A preliminary study on the efficacy of sertraline and imipramine on anger attacks in atypical depression and dysthymia.  Psychopharmacol Bull. 1997;  33 101-103
    PubMedGoogle Scholar
  • 17 Frankenburg F, Zanarini M. Divalproex sodium treatment of women with borderline personality disorder and bipolar II disorder: a double-blind placebo-controlled pilot study.  J Clin Psychiatry. 2002;  63 442-446
    CrossrefPubMedGoogle Scholar
  • 18 Goedhard LE, Stolker JJ, Heerdink ER. et al . Pharmacotherapy for the treatment of aggressive behavior in general adult psychiatry: A systematic review.  J Clin Psychiatry. 2006;  67 1013-1024
    CrossrefPubMedGoogle Scholar
  • 19 Hollander E, Allen A, Lopez RP. et al . A preliminary double-blind, placebo-controlled trial of divalproex sodium in borderline personality disorder.  J Clin Psychiatry. 2001;  62 199-203
    CrossrefPubMedGoogle Scholar
  • 20 Hollander E, Tracy KA, Swann AC. et al . Divalproex in the treatment of impulsive aggression: efficacy in cluster B personality disorders.  Neuropsychopharmacology. 2003;  28 1186-1197
    PubMedGoogle Scholar
  • 21 Hunter M, Carmel H. The cost of staff injuries from inpatient violence.  Hospital and Community Psychiatry. 1992;  43 586-588
    PubMedGoogle Scholar
  • 22 Jadad AR, Moore RA, Carroll D. et al . Assessing the quality of reports of randomized clinical trials: is blinding necessary?.  Control Clin Trials. 1996;  17 1-12
    CrossrefPubMedGoogle Scholar
  • 23 Lipman RS, Covi L, Rickels K. et al . Imipramine and chlordiazepoxide in depressive and anxiety disorders. I. Efficacy in depressed outpatients.  Arch Gen Psychiatry. 1986;  43 68-77
    CrossrefPubMedGoogle Scholar
  • 24 Maoz G, Stein D, Meged S. et al . The antiaggressive action of combined haloperidol-propranolol treatment in schizophrenia.  European Psychologist. 2000;  5 312-325
    CrossrefPubMedGoogle Scholar
  • 25 Marder SR, Davis JM, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials.  J Clin Psychiatry. 1997;  58 538-546
    CrossrefPubMedGoogle Scholar
  • 26 Mattes JA. Comparative effectiveness of carbamazepine and propranolol for rage outbursts.  J Neuropsychiatry Clin Neurosci. 1990;  2 159-164
    PubMedGoogle Scholar
  • 27 McDougle CJ, Naylor ST, Cohen DJ. et al . A double-blind, placebo-controlled study of fluvoxamine in adults with autistic disorder.  Arch Gen Psychiatry. 1996;  53 1001-1008
    PubMedGoogle Scholar
  • 28 Min SK, Rhee CS, Kim CE. et al . Risperidone versus haloperidol in the treatment of chronic schizophrenic patients: a parallel group double-blind comparative trial.  Yonsei Med J. 1993;  34 179-190
    PubMedGoogle Scholar
  • 29 Monnelly EP, Ciraulo DA, Knapp C. et al . Low-dose risperidone as adjunctive therapy for irritable aggression in posttraumatic stress disorder.  J Clin Psychopharmacol. 2003;  23 193-196
    CrossrefPubMedGoogle Scholar
  • 30 Nickel MK, Nickel C, Mitterlehner FO. et al . Treatment of aggression with topiramate in male borerline patients: a double-blind, placebo-controlled study.  Biol Psychiatry. 2005;  57 495-499
    CrossrefPubMedGoogle Scholar
  • 31 Nijman H, Muris P. et al . The staff observation aggression scale Revised (SOAS-R).  Aggress Behav. 1999;  25 197-209
    CrossrefPubMedGoogle Scholar
  • 32 Peuskens J. Risperidone in the treatment of patients with chronic schizophrenia: a multi-national, multi-centre, double-blind, parallel-group study versus haloperidol. Risperidone Study Group.  Br J Psychiatry. 1995;  166 712-726 ; discussion 727-733
    CrossrefPubMedGoogle Scholar
  • 33 Ratey JJ, Sorgi P, O'Driscoll GA. et al . Nadolol to treat aggression and psychiatric symptomatology in chronic psychiatric inpatients: a double-blind, placebo-controlled study.  J Clin Psychiatry. 1992;  53 41-46
    PubMedGoogle Scholar
  • 34 Rinne T, van den Brink W, Wouters L. et al . SSRI treatment of borderline personality disorder: a randomized, placebo-controlled clinical trial for female patients with borderline personality disorder.  Am J Psychiatry. 2002;  159 2048-2054
    CrossrefPubMedGoogle Scholar
  • 35 Salzman C, Wolfson AN, Schatzberg A. et al . Effect of fluoxetine on anger in symptomatic volunteers with borderline personality disorder.  J Clin Psychopharmacol. 1995;  15 23-29
    CrossrefPubMedGoogle Scholar
  • 36 Soloff PH, George A, Nathan S. et al . Amitriptyline versus haloperidol in borderlines: final outcomes and predictors of response.  J Clin Psychopharmacol. 1989;  9 238-246
    CrossrefPubMedGoogle Scholar
  • 37 Soloff PH, George A, Nathan RS. et al . Progress in pharmacotherapy of borderline disorders. A double-blind study of amitriptyline, haloperidol, and placebo.  Arch Gen Psychiatry. 1986;  43 691-697
    PubMedGoogle Scholar
  • 38 Starfield B. Quality-of-care research: internal elegance and external relevance.  JAMA. 1998;  280 1006-1008
    CrossrefPubMedGoogle Scholar
  • 39 Tlusta E, Handoko KB, Majoie M. et al . Clinical relevance of patients with epilepsy included in clinical trials.  Epilepsia. 2008;  49 1479-1480
    CrossrefPubMedGoogle Scholar
  • 40 van der Kolk BA, Dreyfuss D, Michaels M. et al . Fluoxetine in posttraumatic stress disorder.  J Clin Psychiatry. 1994;  55 517-522
    PubMedGoogle Scholar
  • 41 Vartiainen H, Tiihonen J, Putkonen A. et al . Citalopram, a selective serotonin reuptake inhibitor, in the treatment of aggression in schizophrenia.  Acta Psychiatr Scand. 1995;  91 348-351
    CrossrefPubMedGoogle Scholar
  • 42 Zanarini MC, Frankenburg FR. Olanzapine treatment of female borderline personality disorder patients: a double-blind, placebo-controlled pilot study.  J Clin Psychiatry. 2001;  62 849-854
    CrossrefPubMedGoogle Scholar
  • 43 Zanarini MC, Frankenburg FR, Parachini EA. A preliminary, randomized trial of fluoxetine, olanzapine, and the olanzapine-fluoxetine combination in women with borderline personality disorder.  J Clin Psychiatry. 2004;  65 903-907
    CrossrefPubMedGoogle Scholar
  • 44 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;  159 469-473
    CrossrefPubMedGoogle Scholar
  • 45 Wisniewski SR, Rush AJ, Nierenberg AA. et al . Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D Report.  Am J Psychiatry. 2009;  166 599-607
    CrossrefPubMedGoogle Scholar

Correspondence

E. R. Heerdink

Utrecht University

Faculty of Science

Utrecht Institute for

Pharmaceutical Sciences

Division of Pharmacoepidemiology & Pharmacotherapy

PO Box 80 082

3508 TB Utrecht

The Netherlands

Phone: +31-3025 37 324

Fax: +31-3025 39 166

Email: E.R.Heerdink@uu.nl