Protection of human subjects in intervention research for suicidal behavior

American Journal of Psychiatry

Volumn 161, Issue 9, 2004, Pages 1558-1563

  Oquendo, Maria A ^a,b   Stanley, Barbara ^a   Ellis, Steven P ^a   Mann, J John ^a  

^a NEW YORK STATE PSYCHIATRIC INSTITUTE   (United States)

^b NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LITHIUM; VALPROIC ACID;

BENEFICENCE; BIPOLAR DISORDER; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; JUSTICE; LETHALITY; MENTAL PATIENT; METHODOLOGY; MORBIDITY; MORTALITY; OUTCOMES RESEARCH; PATIENT MONITORING; PATIENT RIGHT; PRESCRIPTION; PRIORITY JOURNAL; PSYCHOPHARMACOTHERAPY; RANDOMIZED CONTROLLED TRIAL; RESEARCH ETHICS; REVIEW; RISK; SOCIAL PSYCHOLOGY; SUICIDAL BEHAVIOR; TYPES OF STUDY;

BELMONT REPORT; BIOMEDICAL AND BEHAVIORAL RESEARCH;

BIOMEDICAL RESEARCH; BIPOLAR DISORDER; ETHICS, CLINICAL; ETHICS, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; PATIENT RIGHTS; PATIENT SELECTION; RESEARCH DESIGN; RISK ASSESSMENT; SUICIDE;

EID: 4444263791     PISSN: 0002953X     EISSN: None     Source Type: Journal    
DOI: 10.1176/appi.ajp.161.9.1558     Document Type: Review

References (27)

1. National Center for Injury Prevention and Control: Suicide in the United States. Atlanta, Centers for Disease Control and Prevention, 2002
2. Meltzer HY, Alphs L, Green AI, Altamura AC, Anand R, Bertoldi A, Bourgeois M, Chouinard G, Islam MZ, Kane J, Krishnan R, Lindenmayer JP, Potkin S: Clozapine treatment for suicidality in schizophrenia: International Suicide Prevention Trial (InterSePT). Arch Gen Psychiatry 2003; 60:82-91
3. Tondo L, Hennen J, Baldessarini RJ: Lower suicide risk with long-term lithium treatment in major affective illness: a meta-analysis. Acta Psychiatr Scand 2001; 104:163-172
4. Goldsmith SK, Pellmar TC, Kleinman AM, Bunney WE: Reducing Suicide: A National Imperative. Washington, DC, National Academies Press, 2002
5. US Food and Drug Administration: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research: Appendix F. Washington, DC, US Food and Drug Administration, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1998, pp 1-11
6. Appelbaum PS, Grisso T, Frank E, O'Donnell S, Kupfer DJ: Competence of depressed patients or consent to research. Am J Psychiatry 1999; 156:1380-1384
7. Carpenter WT Jr, Gold JM, Lahti AC, Queern CA, Conley RR, Bartko JJ, Kovnick J, Appelbaum PS: Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry 2000; 57:533-538
8. Radden J: Psychiatric ethics. Bioethics 2002; 16:397-411
9. Fisher CB, Pearson JL, Kim S, Reynolds CF: Ethical issues in including suicidal individuals in clinical research. IRB 2002; 24: 9-14
10. Pearson JL, Stanley B, King CA, Fisher CB: Intervention research with persons at high risk for suicidality: safety and ethical considerations. J Clin Psychiatry 2001; 62:17-26
11. Kallner G, Lindelius R, Petterson U, Stockman O, Tham A: Mortality in 497 patients with affective disorders attending a lithium clinic or after having left it. Pharmacopsychiatry 2000; 33: 8-13
12. Post RM, Luckenbaugh DA: Unique design issues in clinical trials of patients with bipolar affective disorder. J Psychiatr Res 2003; 37:61-73
13. Goodwin FK, Jamison KR: Suicide in Manic-Depressive Illness. New York, Oxford University Press, 1990
14. Chen YW, Dilsaver SC: Lifetime rates of suicide attempts among subjects with bipolar and unipolar disorders relative to subjects with other axis I disorders. Biol Psychiatry 1996; 39:896-899
15. Tondo L, Baldessarini RJ, Hennen J, Minnai GP, Salis P, Scamonatti L, Masia M, Ghiani C, Mannu P: Suicide attempts in major affective disorder patients with comorbid substance use disorders. J Clin Psychiatry 1999; 60:63-69
16. Dilsaver SC, Chen Y-W, Swann AC, Shoaib AM, Krajewski KJ: Suicidality in patients with pure and depressive mania. Am J Psychiatry 1994; 151:1312-1315
17. Oquendo MA, Waternaux C, Brodsky B, Parsons B, Haas GL, Malone KM, Mann JJ: Suicidal behavior in bipolar mood disorder: clinical characteristics of attempters and nonattempters. J Affect Disord 2000; 59:107-117
18. Strakowski SM, McElroy SL, Keck PE Jr, West SA: Suicidality among patients with mixed and manic bipolar disorder. Am J Psychiatry 1996; 153:674-676
19. Sachs GS, Printz DJ, Kahn DA, Carpenter D, Docherty JP: The Expert Consensus Guideline Series: Medication Treatment of Bipolar Disorder 2000. Postgrad Med 2000(April Special Number)
20. Oquendo MA, Barrera A, Mann JJ: Psychopharmacologic strategies for the prevention of suicidal behavior in bipolar patients. Clin Neurosci Res 2001; 1:387-393
21. Beck AT, Kovacs M, Weissman A: Assessment of suicidal intention: the Scale for Suicide ideation. J Consult Clin Psychol 1979; 47:343-352
22. Miklowitz DJ, Goldstein MJ: Behavioral family treatment for patients with bipolar affective disorder. Behav Modif 1990; 14: 457-489
23. Norquist G, Lebowitz B, Hyman S: Expanding the frontier of treatment research. Prevention & Treatment, vol 2, March 21, 1999, article 0001A. http://journals.apa.org/prevention/ volume2/pre0020001a.html
24. Roberts LW, Warner TD, Brody JL: Perspectives of patients with schizophrenia and psychiatrists regarding ethically important aspects of research participation. Am J Psychiatry 2000; 157: 67-74
25. Vincent C: Understanding and responding to adverse events. N Engl J Med 2003; 348:1051-1056
26. Kaufman KR: Comparative bioethics in bipolar and epilepsy research. Seizure 2002; 11:51-56
27. Post RM, Denicoff KD, Leverich GS: Special issues in trial design and use of placebo in bipolar illness. Biol Psychiatry 2000; 47: 727-732