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MENTAL HEALTH: A REPORT OF THE SURGEON GENERAL
APPENDIX A
INCLUSION OF MINORITIES IN CONTROLLED CLINICAL TRIALS USED TO DEVELOP PROFESSIONAL TREATMENT GUIDELINES FOR MAJOR MENTAL DISORDERS
This appendix1 examined the inclusion of racial and ethnic minorities
in randomized clinical trials used to develop professional guidelines
for treatment of four specific mental disorders: bipolar disorder, major
depression, schizophrenia, and attention-deficit/hyperactivity disorder.
The American Psychiatric Association (1994) developed practice guidelines for
treatment of patients with bipolar disorder. Their guidelines were based
on a review of all relevant studies, including randomized con-trolled
clinical trials. This appendix considered the representation of minorities
in all randomized trials conducted in the United States during the most
recent 10-year period (1983–1994). Results are presented in Table
A–1. Seventeen of these studies represented 16 separate patient
populations. Two articles reported on the same subjects, but these subjects
are only included once in this review. Of 825 participants, 29 were
identified as non-white, and 32 were identified as black. No analyses
were conducted to determine if these participants differed from white
participants in outcomes. As a result, the treatment guidelines for
patients with bipolar disorder developed by the APA do not offer any
information on expected outcomes for minority persons.
The American Psychiatric Association (1997) conducted a similar review to develop
guidelines for schizophrenia. Results are presented in Table A–2.
Twenty-five randomized clinical trials that occurred in the United States
between 1986 and 1997 were included in this analysis. A total of 2,865
participants were included in these 25 studies. Of those participants,
316 were identified as nonwhite, 376 as African American, 40 as Hispanic,
and 3 as Asian American. Although several studies had a modest African
American sample (39–74), none analyzed results separately for
African Americans or presented outcomes specifically for them. As a
result, the guidelines developed by the APA to guide treatments for
those with schizophrenia do not provide information regarding potentially
different outcomes for African Americans or any other ethnic minorities.
The American Psychiatric Association (2000) conducted a similar review to develop
treatment guidelines for major depression. Randomized clinical trials
conducted between 1986–1997 were evaluated, with 27 studies included.
Results are presented in Table A–3. A total of 3,980 patients
were involved. Amoung them, 241 were nonwhite, 150 were African American,
and 2 were Asian American. None of the studies analyzed minority participants
separately. The one study with a sizeable African American population
(N=123) did find similar clinical outcomes as a result of depression
care, although there were differences in functional outcomes.
To examine the inclusion of ethnic minority children in research, this appendix
reviewed the randomized trials of interventions for attention-deficit/hyperactivity
disorder (AD/HD) used by a multidisciplinary team assembled by the Agency
for Healthcare Research and Quality (AHRQ). These trials were used to
develop an evidence-based report on treatment (AHRQ, 1999). Thirty-two
studies from 1988 to 1999 were eligible for review. Results are presented
in Table 4. These studies evaluated 1,657 children with AD/HD. Of those
children, 126 were African American, 55 Hispanic, 4 nonwhite, and 1
each Asian American, Pacific Islander, East Indian, and Asian Indian.
With the exception of the recent multisite study sponsored by the National
Institute of Mental Health, the largest inclusion of minorities in any
study was 5. However, in the recent NIMH trial, 115 African Americans
and 48 Latinos were included. Although not analyzed separately in this
Supplement, further reports analyzing outcomes for the ethnic minorities
could still be forthcoming.
The American Psychological Association recently reviewed empirically validated
therapies, namely, those therapies judged by a panel of scientists to
be effective, according to explicit criteria for empirical studies (Chambless
et al., 1996). Their report states;
Examining the citations for empirically validated therapies identified
in the 1995 task force report, we find not a single study included
tests of the efficacy of the treatment for ethnic minority
populations. Most investigators did not specify ethnicity of
subjects or used only white subects. Out of about 41 studies
cited, only 6–7 made any reference to race or ethnicity
of subjects. No one used ethnicity as a variable of interest.
Overall, minorities are not represented in studies that evaluate the impact of
interventions for major mental disorders. Furthermore, when minorities
are included, rarely are analyses conducted to determine whether the
treatments are as effective for them as they are for white populations.
Although a great deal is known about efficacy of a wide range of interventions
for treating common mental disorders, specific information about the
efficacy of these interventions for racial and ethnic minority populations
is unavailable.
References
Agency for Healthcare Research and Quality. (1999). Treatment of Attention-Deficit/Hyperactivity
Disorder: Summary, evidence report/technology assessment No.
11 (AHCPR Publication No. 99–E018). Rockville, MD: Author.
American Psychiatric Association. (1994). Practice guideline for treatment of
patients with bipolar disorder. American Journal of Psychiatry,
151 (12th suppl.), 1–36.
American Psychiatric Association. (1997). Practice guideline for treatment of
patients with bipolar disorder. American Journal of Psychiatry,
154 (4th suppl.), 1–63.
American Psychiatric Association. (2000). Practice guideline for treatment of
patients with bipolar disorder. American Journal of Psychiatry,
157 (4th suppl.), 1–45.
Chambless, D. L., Sanderson, W. C., Shoham, V., Bennett Johnson, S., Pope, K.
S., Crits-Christoph, P., Baker, M., Johnson, B., Woody, S. R., Sue,
S., Beutler, L., Williams, D. A., & McCurry, S. (1996). An update
on empirically validated therapies. The Clinical Psychologist, 49,
5–18.
Table A-1: Representation of Minorities in Randomized Controlled
Trials for Treatment of Bipolar Disorder
Study |
Sample |
Information on ethnicity sample |
Analyses by ethnicity |
| Dubovsky, Franks, Allen, & Murphy, (1986) |
N = 7 |
No |
No |
| Giannini, Taraszewski, & Loiselle, (1987) |
N = 20 |
All white, male patients |
N/A |
| Cohn, Collins, Ashbrook, et al., (1989) |
N = 89 |
No |
No |
| Gelenberg, Kane, Keller, et al., (1989) |
N = 94 |
No mention |
No |
| Clarkin, Glick, Haas, et al., (1990) |
N = 50 |
35 white 15 nonwhite |
No |
| Gallagher-Thompson, Hanley-Peterson, & Thompson, (1990) |
N = 91 |
No |
No |
| O'Leary & Beach, (1990) |
N = 36 couples |
No |
No |
| Himmelhoch, Thase, Mallinger, et al., (1991) |
N = 56 |
52 white 4 nonwhite |
No |
| Jacobson, Dobson, Fruzzetti, et al., (1991) |
N = 60 couples |
No |
No |
| Pope, McElroy, Keck, et al., (1991) |
N = 36 |
No |
No |
| Small, Klapper, Milstein, et al., (1991) |
N = 52 |
No |
No |
| Garza-Treviño, Overall, & Hollister, (1992) |
N = 20 |
No |
No |
| Lenox, Newhouse, & Creelman, (1992) |
N = 20 |
No |
No |
| Bowden, Brugger, Swann, et al., (1994) |
N = 179 |
127 white 32 black 20 other |
No |
| Sachs, Lafer, Stoll, et al., (1994) |
N = 15 |
No |
No |
Table excludes studies published before 1986. Table excludes studies with samples outside United States.
|
References
Bowden, C. L., Brugger, A. M., Swann, A. C., Calabrese, J. R., Janicak,
P 6., Petty, F., Dilsaver, S.C., Davis, J. M., Rush, A. J., Small, J.
6., Garza-Trevino, E. S., Risch, S. C., Goodnick, P. J., & Morris,
D. D. (1994). Efficacy of divalproex vs lithium and placebo in the treatment
of mania. The Depakote Mania Study Group. Journal
of the American Medical Association, 27], 918-924.
Clarkin, J. F., Glick, I. D., Hass, G. L., Spencer, J. H., Lewis, A. B.,
Peyser, J., DeMane, N., Good-Ellis, M., Harris, E., & Lestelle,
V. (1990). A randomized clinical trial of inpatient family intervention.
V. Results for affective disorders. Journal
of Affective Disorders, 18, 17-28.
Cohn, J. B., Collins, 6., Ashbrook, E., & Wernicke, J. F. (1989).
A comparison of fluoxetine imipramine and placebo in patients with bipolar
depressive disorder. International ClinicalPsychopharmacology, 4, 313-322.
Dubovsky, S. L., Franks, R. D., Allen, S., & Murphy, J. (1986). Calcium
antagonists in mania: A double-blind study of verapolmil. Psychiatry Research, 18, 309-320.
Gallagher-Thompson,D., Hanley-Peterson, P.,& Thompson, L. W.
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Clinical Psychology, 58, 371-374
Garza-Trevifio, E. S., Overall, J. E., & Hollister, L. E. (1992).
Verapamil versus lithium in acute mania. American
Journal of Psychiatry, 149, 121-122.
Gelenberg, A. J., Kane, J. M., Keller, M. B., Lavori, P., Rosenbaum, J. F., Cole, K., & Lavelle, J. (1989). Comparison of standard and low serum levels of lithium for maintenance treatment of bipolar disorder. New England Journal of Medicine, 32], 1489-1493.
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A placebo controlled study. Archives of General Psychiatry 48,
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versus desipramine for bipolar depression. Journal
of Clinical Psychiatry, 55, 391-393.
Small, J. G., Klapper, M. H., Mustein, V., Kellams, J. J., Marhenke, J.
D., & Small, I. F. (1991). Carbamazepine compared with lithium in
the treatment of mania. Archives
of General Psychiatry, 48, 915-921.
Table A-2 provides the representation of minorities in randomized controlled trials for treatment of schizophrenia.
Study |
Sample |
Information on ethnicity sample |
Analyses by ethnicity |
| Hogarty, Anderson, Reiss, et al., (1986) |
N = 103 |
81% white (n = 83.4) No other information |
No |
| Carpenter, Heinrichs, & Hanlon, (1987) |
N = 42 |
8 white 34 black |
No |
| Claghorn, Honigfeld, & Abuzzahab, (1987) |
N = 151 |
No |
No |
| Marder, Van Putten, Mintz, et al., (1987) |
N = 66 |
32% white (n = 21) 59% black (n = 39) 6% Hispanic (n = 4) 3% other (n = 2) |
No |
| Csernansky, Riney, Lombrozo, et al., (1988) |
N = 55 |
No |
No |
| Hogarty, McEvoy, Munetz, et al., (1988) |
N = 70 |
67% white (n = 47) No other information |
No |
| Kane, Honigfeld, Singer, et al., (1988) |
N = 319 couples |
65% white (n = 208) 23% black (n = 74) 10% Hispanic (n = 31) 1% Asian (n = 2) 1% other (n = 4) |
No |
| Kramer, Vogel, DiJohnson, et al., (1989) |
N = 58 |
No |
No |
| Herz, Glazer, Mostert, et al., (1991) |
N = 101 couples |
56 white 45 black |
No |
| Salzman, Solomon, Miyawaki, et al., (1991) |
N = 60 |
No |
No |
| Borison, Pathiraja, Diamond, et al., (1992) |
N = 36 |
20 white 15 black 1 Hispanic |
No |
| Eckman, Wirshing, Marder, et al., (1992) |
N = 41 (40 with ethnic data available) |
14 white 23 black 3 Hispanic |
No |
| Pickar, Owen, Litman, et al., (1992) |
N = 21 |
No |
No |
| Breier, Buchanan, Irish, et al., (1993) |
N = 35 |
26 white 9 black |
No |
| McEvoy, Borrison, Small, et al., (1993) |
N = 38 |
No |
No |
| Marder & Meibach, (1994) |
N = 388 |
244 white 144 nonwhite |
No |
| Marder, Wirshing, Van Putten, et al., (1994) |
N = 80 |
58 nonwhite No other information |
No |
| Randolph, Eth Glynn, et al., (1994) |
N = 41 |
14 white 19 black 5 Hispanic 3 Asian |
No |
| DeSisto, Harding, McCormick, et al., (1995) |
N = 269 |
No |
No |
| Hogarty, McEvoy, Ulrich, et al., (1995) |
N = 128 (trial), same pool of subjects used for 2 subsequent trials |
Trial 1: 74% white (n = 95) Trial 2: no information Trial 3: 83% white (n = 51) |
No |
| Beasley, Tollefson, Tran, et al., (1996) |
N = 335 (299 subjects with race reported) |
*77% white (n = 230) 23% black (n = 69) |
No |
| Drake, McHugo, Becker, et al., (1996) |
N = 143 |
95% white (n = 136) No other information |
No |
| Marder, Wirshing, Mintz, et al., (1996) (different study from Marder 1994 above) |
N = 80 |
No |
No |
| Schulz, Mack, Zborowski, et al., (1996) |
No sample size reported (brief report of findings from "two large" studies) |
No |
No |
| van Kammen, McEvoy, Targum, et al., (1996) |
N = 153 in evaluable data set with demographic information reported (205 randomized) |
58% white (n = 90) 32% black (n = 49) 9% other (n = 14) |
No |
*information is approximate (numbers in published table do not add up to total sample size). Table excludes studies published before1986. Table excludes studies with samples outside United States.
|
References
Beasley, C. M., Jr., Tollefson, G., Tran, P., Satterlee, W.,
Sanger, T., Hamilton, S., Fabre, L., Small, J.,
Ereshevsky, L., True, J., Nemeroff, C., Risch, S. C.,
Perry, P. J., Potkin, S. 6., Borison, R. L., James, S.,
Meltzewr, H. Y., Ighal, N., Fann, W. E., Gewitt, 6. R.,
Landbloom, R., Roybyme, P. P, Tudson, V. B., Carman,
I. S., Stokes, P. E., et al. (1996). Olanzapine versus placebo and haloperidol: Acute phase results of the North Americandouble-blind olanzapine trial. Neuropsychopharmacology, 14, 111-123.
Borison, R. L., Pathiraja, A. P., Diamond, B. I., & Meibach, R. C.
(1992). Risperidone: Clinical safety and efficacy in schizophrenia.
Psychopharmacological Bulletin, 28, 213-218.
Breier, A., Buchanan, R. W., Irish, D., & Carpenter, W T., Jr. (1993).
Clozapine treatment of outpatients with schizophrenia: Outcome and long-term
response patters. Hospital and Community Psychiatry, 44, 1145-1149.
Carpenter, W. T., Jr., Heinrichs, D. W., & Hanlon, T. E. (1987). A
comparative trial of pharmacologic strategies in schizophrenia. American Journal of Psychiatry, 144, 1466-1470.
Claghorn, J., Honigfeld, 6., Abuzzahab, F. S., Wang, R., Steinbook, R.,
Tuason, V., & Klerman, 6. (1987). The risks and benefits of clozapine
versus chlorpromazine. Journal of Clinical Psychopharmacology, 7, 377-384.
Csernansky, J. 6., Riney, S. J., Lombarozo, L., Overall, J. E., &
Hollister, L. E. (1988). Double-blind comparison of alprazolam, diazepam
and placebo for the treatment of negative schizophrenic symptoms. Archives of General Psychiatry, 45, 655-659.
De Sisto, M. J., Harding, C. M., McCormick, R. V., Ashikaga, T., & Brooks, 6. W. (1995). The Maine and Vermont three-decade studies of serious mental illness,
I: Matched comparison of cross-sectional outcome. British Journal of Psychiatry, 167, 331-342.
Drake, R. E., McHugo, 6. J., Becker, D. R., Anthony, W. A.,
& Clark, R. E. (1996). The New Hampshire study of
supported employment for people with severe mental
illness. Journal of Consulting Clinical Psychology, 64, 391-399.
Eckman, T. A., Wirshing, W. C., Marder, S. R., Liberman, R.
P, Johnston-Cronk, K., Zimmermann, K., & Mintz, J.
(1992). Technique for training schizophrenic patients in
illness self-management: A controlled trial. American Journal of Psychiatry, 149,1549-1555.
Herz, M. I., Glazer, W M., Mostert, M. A., Sheard, M. A., Szymanski, H. V., Hafez, H., Mirza, M., & Vana, J. (1991). Intermittent vs. maintenance medication in
schizophrenia: Two-year results. Archives of General Psychiatry, 48, 333-339.
Hogarty, G.E., Anderson, C. M., Reiss, D. J., Komblith, S. J., Greenwald,
D. P, Javna, C. D., & Madonia, M. I. (1986). Family psychoeducation,
social skills training, and maintenance chemotherapy in the altercare
treatment of schizophrenia, I: One-year effects of a controlled study
on relapse and expressed emotion. Archives
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Hogarty, G.E., McEvoy, J. P, Munetz, M., DiBarry, A. L., Bartone, P, Cather, R., Cooley, S. J., Ulneb, R. E,
Carter, M., & Madonia, M. J. (Environmentallpersonal
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expressed emotion, and outcome in schizophrenia:
Results of a two-year controlled study. Archives of General Psychiatry, 45, 797-805.
Hogarty, G.E., McEvoy, J. P, Ulrich, R. E, DiBarry, A. L., Bartone, P.,
Cooley, S., Hammill, K., Carter, M., Munetz, M. R., & Perel, J.
(1995). Pharmacotherapy of impaired affect in recovering schizophrenic
patients. Archives of General Psychiatry, 52, 2941.
Kane, J., Honigfeld, G., Singer, J., & Meltzer, H. (1988). Clozapine
for the treatment-resistant schizophrenic: A double-blind comparison
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Kramer, M. S., Vogel, W. H., DiJohnson, C., Dewey, D. A., Sheves, P, Cavicchia,
S., Little, P, Schmidt, R., & Kimes, I. (1989). Antidepressants
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Table A-3 provides the representation of minorities in randomized controlled trials for treatment of depression.
Study |
Sample |
Information on ethnicity sample |
Analyses by ethnicity |
| Kocsis, Frances, Voss, et al., (1988) |
N = 76 |
No |
No |
| Liebowitz, Quitkin, Stewart, et al., (1988) |
N = 119 |
No (subject description published in 1984 report) |
No |
| Quitkin, Stewart, McGrath, et al., (1988) |
N = 60 |
No |
No |
| Elkin, Shea, Watkins, et al., (1989) |
N = 239 |
212 white No other information |
No |
| Feighner, Pambakian, Fowler, et al., (1989) |
N = 45 |
No |
No |
| Frank, Kupfer, Perel, et al., (1990) |
N = 128 |
No |
No |
| Quitkin, McGrath, Stewart, et al., (1990) |
N = 90(different sample from 1988 study) |
No |
No |
| Feighner, Gardner, Johnston, et al., (1991) |
N = 123 |
No |
No |
| Quitkin, Harrison, Stewart, et al., (1991) |
N = 64 |
No |
No |
| Kupfer, Frank, Perel, et al., (1992) |
N = 20 (sample drawn from Frank, 1990) |
No |
No |
| Shea, Elkin, Imber, et al., (1992) |
N = 239 (same sample as Elkin, et al., 1989) |
No (1989 sample is 212/239 white, no other information) |
No |
| Thase, Mallinger, McKnight, et al., (1992) |
N = 16 |
14 white 23 black 3 Hispanic |
No |
| Frank, Kupfer, Perel, et al., (1993) |
N = 20 (sample drawn from Frank, et al., 1990) |
No |
No |
| Sackheim, Prudic, Devanand, et al., (1993) |
N = 96 |
No |
No |
| Cunningham, Borison, Carman, et al., (1994) |
N = 225 |
No |
No |
| Fontaine, Ontiveros, Elie, et al., (1994) |
N = 180 |
No |
No |
| Schweizer, Feighner, Mandos, et al., (1994) |
N = 224 |
No |
No |
| Weisler, Johnston, Lineberry, et al., (1994) |
N = 124 |
112 white No other information |
No |
| Claghorn & Lesem, (1995) |
N = 90 |
No |
No |
| McElhiney, Moody, Steif, et al., (1995) (investigates post-ECT amnesia) |
N = 91 |
No |
No |
| Mendels, Reimherr, Marcus, et al., (1995) |
N = 240 |
214 white 26 other |
No |
| Kelsey, (1996) |
Study 1: N = 60 Study 2: N = 312
|
Study 1: No Study 2: No |
Study 1: No Study 2: No |
| Pande, Birkett, & Fechner-Bates, (1996) |
N = 42 |
38 white 2 African 2 Asian |
No |
| Schulberg, Block, Madonia, et al., (1996) |
N = 276 |
153 white No other information |
No (study notes significantly more attrition among non-whites in nortriptyline condition) |
| Chaudhry, Najam, & Naqvi, (1998) |
N = 100 |
No |
No |
| Keller, Gelenberg, Hirschfeld, et al., (1998) |
N = 635 |
57 white 25 black 33 other |
No |
| Bright, Baker, & Neimeyer, (1999) |
N = 98 |
91 white (93%) No other information |
No |
| Reynolds, Frank, Perel, et al., (1999) |
N = 187 |
174 white (93.1%) No other information |
No |
Table excludes studies published before 1986. Table excludes studies with samples outside United States.
|
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Table A-4 provides the representation of minorities in randomized controlled trials for treatment of AD/HD.
Study |
Sample |
Information on ethnicity sample |
Analyses by ethnicity |
| Fitzpatrick, Klorman, Brumaghim, et al., (1992) |
N = 19 (analyzed) |
No |
No |
| Srinivas, Hubbard, Quinn, et al., (1992) |
N = 9 |
No |
No |
| Borcherding, Keysor, Cooper, et al., (1989) |
N = 18 |
No |
No |
| Castellanos, Giedd, Elia, et al., (1997) |
N = 22 |
16 white 2 black 1 Asian 1 Hispanic |
No |
| Efron, Jarman, & Barker, (1997) |
N = 125 |
No |
No |
| Elia, Borcherding, Rapoport, et al., (1991) |
N = 48 |
No |
No |
| Matochik, Liebenauer, King, et al., (1994) |
N = 37 (analyzed)(different sample from 1988 study) |
No |
No |
| Pelham, Greenslade, Vodde-Hamilton, et al., (1990) |
N = 22 |
No |
No |
| Rapport, Carlson, Kelly, et al., (1993) |
N = 16 |
14 white 2 black |
No |
| Arnold, Kleykamp, Votolato, et al., (1989) |
N = 18 (analyzed) |
No |
No |
| Klein & Abikoff, (1997) |
N = 89 (no break down given) |
?? white ?? African American ?? Hispanic ?? Asian |
No |
| MTA Coop Group, (1999) |
N = 579 |
351 white 115 African American 48 Hispanic |
No |
| Levy, Hobbes, (1996) |
N = 10 |
No |
No |
| Long, Rickert, & Ashcraft, (1993) |
N = 32 |
No |
No |
| Borden & Brown (1989) |
N = 30 |
No |
No |
| Brown, Borden, Wynne, et al., (1988) |
N = 71 |
No |
No |
| Carlson, Pelham, Milich, et al., (1992) |
N = 24 |
No |
No |
| Hinshaw, Buhrmester, & Heller, (1989) |
N = 24 |
17 white 4 black 1 Hispanic 1 Pacific Islander 1 East Indian |
No |
| Pelham, Carlson, Sams, et al., (1993) |
N = 31 |
29 white 2 black |
No |
| Solanto, Wender, & Bartell, (1997) |
N = 22 |
16 white 5 Hispanic 1 Asian Indian |
No |
| Biederman, Baldessarini, Wright, et al., (1989) a+b |
N = 73 |
69 white 4 other |
No |
| Gualtieri, Keenan, & Chandler, (1991) |
N = 12
|
No |
No |
| Singer, Brown, Quaskey, et al., (1995) |
N = 37 (34 completed) |
33 white 1 black |
No |
| Wilens, Biederman, Prince, et al., (1996) |
N = 43 |
No |
No |
| Gualtieri & Evans, (1988) |
N = 9 |
No |
No |
| Kupietz, Winsberg, Richardson, et al., (1988) |
N = 58 |
No |
No |
| Schachar, Tannock, Cunningham, et al., (1997) |
N = 91 |
No |
No |
| Gillberg, Melander, von Knorring, et al., (1997) |
N = 62 |
No |
No |
| Fehlings, Roberts, Humphries, et al., (1991) |
N = 26 |
No |
No |
| Linden, Habib, & Radojevic, (1996) |
N = 18 |
No |
No |
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1 This Appendix was prepared by the Senior Scientific Editor for this
Supplement.
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