Psychosomatics 45:210-216, June 2004
© 2004 The Academy of Psychosomatic Medicine
Citalopram Treatment of Major Depressive Disorder in Hispanic HIV and AIDS Patients: A Prospective Study
M. Beatriz Currier, M.D.,
German Molina, M.D., and
Martha Kato, M.D.
Presented in part at the poster session of the 48th annual meeting of the Academy of Psychosomatic Medicine, San Antonio, Tex., Nov. 15–18, 2001. Received Nov. 29, 2002; revision received July 11, 2003; accepted July 28, 2003. From the Department of Psychiatry and Behavioral Sciences, Division of Consultation Psychiatry, University of Miami School of Medicine. Address reprint requests to Dr. Currier, Division of Consultation Psychiatry, Department of Psychiatry (D-79), University of Miami/Jackson Memorial Medical Center, 1400 N.W. 10th Ave., Suite 304A, Miami, FL 33136; bcurrier{at}med.miami.edu (e-mail).
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ABSTRACT
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Fourteen Hispanic and six non-Hispanic outpatients with HIV-spectrum illness and major depressive disorder were enrolled in a 6-week, open-label, flexible-dose study of citalopram (dose range=10–40 mg/day). The depressive symptoms of 50% of the 14 patients who completed the study responded to citalopram (mean dose=34 mg/day). The treatment response rate, effective citalopram dose, total number of reported adverse events, and attrition rate did not differ between the ethnic groups. Two patients discontinued because of adverse events (rash, nausea), and four patients discontinued because of noncompliance with the protocol. The findings suggest that citalopram is an effective and well-tolerated antidepressant for Hispanic and non-Hispanic HIV-infected patients.
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INTRODUCTION
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Hispanics are the largest minority group in the United States, according to the United States Census Bureau's 2002 population estimate.1 They number 38.8 million and make up 13.4% of the U.S. population. The Centers for Disease Control and Prevention reported that Hispanics accounted for 19% of the total number of new AIDS cases during the year 2000.2 Furthermore, in 2000 the AIDS incidence rate was three times higher among Hispanics than among white non-Hispanics. Despite the expansion of the AIDS epidemic in the Hispanic population, few studies have addressed the efficacy and tolerability of medical and psychiatric treatments in this minority group.
Depressive disorders are twice as prevalent among HIV-infected patients than they are in the general population. Approximately 25%–45% of HIV-infected patients have this disabling psychiatric disorder.3 Double-blind, placebo-controlled studies with fluoxetine,4 imipramine,5 and paroxetine,6 as well as open-label studies evaluating sertraline,7 nefazodone,8 mirtazapine,9 and sustained-release buproprion10 have revealed overall rates of positive response to depression treatment ranging from 45% to 80%.
Previous studies of the effects of antidepressants among Hispanic patients have reported inconsistent findings for efficacy rate, tolerability, and adherence to treatment. A retrospective review of the charts of outpatients who were taking tricyclic antidepressants (i.e., amitriptyline, imipramine, and doxepin) found that Hispanic patients had symptom response at half the mean dose of non-Hispanic patients.11 Prospective studies with imipramine found no ethnic differences in effective antidepressant doses.12 Sanchaz-Lacay et al.13 assessed antidepressant treatment outcome in an open-label study of nefazodone among 50 Hispanic patients. Their finding of a 63% response rate with a mean endpoint nefazodone dose of 379 mg/day was similar to the efficacy rates and effective doses reported for non-Hispanics in previous nefazodone trials. In a prospective, controlled trial of the antidepressant effects of fluoxetine, Wagner et al.14 compared response rates and effective doses for 17 Hispanic, 79 white non-Hispanic, and 22 black HIV-seropositive patients. Sixty-seven percent (two of three) of the fluoxetine-treated Hispanics had symptom response, compared to 84% (36 of 43) of the white non-Hispanic patients. No ethnic differences were noted in fluoxetine dosing. The Hispanics had significantly higher attrition and placebo response rates than the non-Hispanics.
Earlier tricyclic antidepressant studies found that Hispanic patients reported more treatment-emergent adverse effects.11,12 The nefazodone and fluoxetine studies, however, found no ethnic differences in reporting of adverse events.13,14 Both studies, however, did find a significantly higher attrition rate among Hispanics.
Because of the anticholinergic side effects of tricyclic antidepressants, the selective serotonin reuptake inhibitor (SSRI) antidepressants are considered first-line treatment for depressed HIV patients. However, the potential for drug interactions between the SSRIs and antiretroviral agents exists because of effects of the 2D6 and 3A4 isoenzymes of the cytochrome P450 system.15–18 The P450 isoenzymes are found in the endoplasmic reticulum in the hepatocytes and the enterocytes of the intestinal lumen. In addition, small concentrations are found in the lung, kidney, and brain. Many antiretroviral agents inhibit the 2D6 and 3A4 isoenzymes or are metabolized by the 3A4 isoenzyme.18 Fluoxetine, fluvoxamine, and paroxetine are primarily metabolized by the 2D6 isoenzyme, and sertraline by the 3A4 isoenzyme.18 Adding a protease inhibitor may increase concentrations of fluoxetine, fluvoxamine, paroxetine, and sertraline by inhibiting their metabolism through the 2D6 and 3A4 isoenzymes.18 Increased SSRI plasma concentrations may increase the incidence of SSRI-associated adverse effects and increase patient noncompliance with antidepressant treatment. Bull et al.19 found that more than 40% of 226 patients treated with SSRIs discontinued treatment because of side effects (e.g., drowsiness, fatigue, anxiety, headache, nausea).
In choosing effective pharmacotherapy for depression in HIV-infected patients, it is important to select an antidepressant that has demonstrated efficacy in this medically complicated population, a tolerable side effect profile, and minimal potential for drug interactions. Citalopram may offer advantages over the other SSRIs because its pharmacokinetic profile minimizes the risk of drug interactions with antiretrovirals. Its primary metabolism is through the P450 isoenzyme 2C19, which is essentially unaffected by antiretroviral agents.18
To our knowledge, no prospective study of the effects of citalopram in depressed HIV-seropositive patients has been reported. This study examines the efficacy and tolerability of citalopram in the treatment of depressed Hispanic and non-Hispanic HIV-seropositive patients. In addition, we wanted to determine whether ethnicity and clinical variables related to HIV and depression were significantly associated with depression treatment outcome.
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METHOD
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Participants
Outpatients with HIV illness, ages 18–75 years, who were receiving medical care at the University of Miami/Jackson Memorial Medical Center Special Immunology Clinic were recruited by the clinic psychiatrist to participate in this antidepressant study. The study was approved by the university's institutional review board. Patients were screened with the Beck Depression Inventory.20 Patients with a baseline Beck Depression Inventory score >15 were referred to the psychiatric consultant for a baseline assessment. All eligible participants required a baseline 17-item Hamilton Depression Rating Scale21 score  18, a Mini-Mental State Examination (MMSE)22 score 25, and a diagnosis of major depressive disorder confirmed with the Structured Clinical Interview for DSM-IV (SCID).23 Psychiatric exclusion criteria included any other active axis I disorder, current suicide risk, current antidepressant pharmacotherapy, and current antipsychotic pharmacotherapy. Medical exclusion criteria included seizure disorder, traumatic brain injury, any active CNS opportunistic infection, and CNS lymphoma.
Study Design and Assessment
All patients provided written informed consent to participate in this 6-week, open-label, flexible-dose antidepressant study with 10–40 mg/day of citalopram. Patients were not compensated for study participation. Baseline assessment included the depression modules of the SCID and a semi-structured review of demographic variables, medical and psychiatric history, antidepressant therapies, neuroimaging studies, current medication regimens, HIV immunological markers (i.e., CD4 cell counts, plasma viral load),24 and HIV clinical markers, including disease stages (i.e., asymptomatic, symptomatic, AIDS) outlined by the Center for Disease Control and Prevention.25 Baseline cognitive measure included the MMSE, and baseline depression measures included the Beck Depression Inventory, the 17-item Hamilton depression scale, and the Clinical Global Impression (CGI) severity scale.26
Citalopram was dispensed at each clinic visit. The initial dose was 10 mg/day for the first 7 days. At week 2, the dose was increased to 20 mg/day for 2 weeks. At week 4, the dose was increased to 40 mg/day for the remaining 3 weeks of the study. As this was a flexible-dose study, the citalopram dose was adjusted as clinically indicated (e.g., the doses of patients with a Hamilton depression scale score 8 were increased) and tolerated.
Patients underwent assessments at baseline and at weeks 2, 4, and 6. Treatment outcome measures at each visit included the Beck Depression Inventory, the 17-item Hamilton depression scale, and the CGI improvement score. Spontaneous reports of treatment-emergent adverse events were documented and rated for severity. Patients whose symptoms responded to treatment were defined by a CGI score of "very much improved" or "much improved" and a 50% reduction in baseline Hamilton depression scale and Beck Depression Inventory scores. Patients with remission were defined by a Hamilton depression scale score <8.
Data Analysis
All data were analyzed by using the Statistical Package for Social Science 10.0 software program (SPSS, Inc., Chicago). Patients with treatment response were compared to patients without treatment response by using t tests for continuous variables and chi-square tests for categorical variables. Fisher's exact test was used if the expected cell frequency was less than five. Patients who did not complete the study but who underwent at least one postbaseline assessment while taking medication were included in the intent-to-treat analysis. Response rates and remission rates were assessed. Paired t tests were used to assess baseline and endpoint treatment outcome measures within a group, whereas independent t tests were used to test for significant differences in HIV or depression variables between the two treatment outcome groups. A similar analysis comparing the Hispanic and non-Hispanic groups was performed to test for ethnic differences in depression treatment outcome, including response rate, effective citalopram dose, attrition rate, and reported number of adverse effects.
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RESULTS
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Patient Demographic and Clinical Variables
Twenty patients (15 men and five women) enrolled in the study. Their mean age was 42.9 years (SD=8.4). Fourteen patients were Hispanic. There were no significant differences in age, sex, race, or ethnicity between the patients with and without treatment response. The Hispanic group had a significantly higher proportion of whites than the non-Hispanic group ( 2=7.94, df=1, p<0.05). The Hispanic group and the non-Hispanic group had similar measures on all other demographic variables.
As for HIV clinical variables, the study participants included asymptomatic HIV-infected patients (N=7, 35%), symptomatic HIV-infected patients (N=2, 10%), and AIDS patients (N=11, 55%). The route of HIV transmission included male-to-male sexual contact in 12 patients (60%), heterosexual contact in seven patients (35%), and intravenous contamination in one patient (5%). The mean duration of HIV infection was 44.05 months (SD=38.83). The mean CD4 cell count was 404.95 cells/mm3 (SD=352.30). Plasma viral load, detectable in 14 patients (70%), ranged from 83 to 750,000 RNA copies/ml. Fifteen patients (75%) were taking antiretroviral medications. HIV clinical variables and immunological markers did not differ between the patients with and without treatment response (Table 1) or between the Hispanic and non-Hispanic patients (Table 2).
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TABLE 1. Characteristics of HIV-Seropositive and AIDS Patients Whose Depressive Symptoms Did and Did Not Respond to Treatment in a 6-Week, Open-Label Trial of Citalopram
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TABLE 2. Characteristics of Hispanic and Non-Hispanic HIV-Seropositive and AIDS Patients With Depression in a 6-Week, Open-Label Trial of Citalopram
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Psychiatric clinical variables were noteworthy for 10 patients (50%) who reported a history of recurrent depression and antidepressant treatment. The mean duration of the current depressive episode was 13.35 months (SD=15.79). Thirteen patients (65%) reported acute (duration <24 months) depression, and the remaining seven patients (35%) reported chronic (duration >24 months) depression. Five patients (20%) had comorbid dysthymia. Although seven patients developed depression within 6 months of receiving a diagnosis of HIV infection, the average time before onset of depression was 36.95 months (SD=39.72) after the diagnosis of HIV infection. At baseline, the patients had a mean Beck Depression Inventory score of 30.35 (SD=9.18, range=15–50), a mean Hamilton depression scale score of 23.25 (SD=3.48, range=18–29), and a mean CGI severity score of 4.45 (SD=0.51, range=4–5). The patients' mean baseline MMSE score was 28.50 (SD=1.79, range=25–30).
Efficacy
Of the 20 patients who were treated with citalopram, 14 patients—10 Hispanic and four non-Hispanic patients—completed the study. In the completer analysis, the depressive symptoms of 50% (seven of 14) of the patients responded to citalopram at a mean dose of 34.29 mg/day (SD=9.76). In an intent-to-treat analysis that included 17 patients with a postbaseline visit, 47% (eight of 17) were rated as having treatment response. The mean effective dose for those patients was 31.25 mg/day (SD=11.11). Two patients (12%) achieved remission. There was no significant difference in the endpoint dose between the groups with and without treatment response (Table 1). The patients with treatment response demonstrated significant improvement from baseline to endpoint in their scores on the Beck Depression Inventory, the Hamilton depression scale, and the CGI severity scale (Table 3).
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TABLE 3. Baseline and Endpoint Treatment Outcome Measures of HIV-Seropositive and AIDS Patients Whose Depressive Symptoms Responded to Treatment in a 6-Week, Open-Label Trial of Citalopram (N=8)
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No significant difference was found between the response rates of the Hispanic group (42%, five of 12 patients) and the non-Hispanic group (60%, three of five patients). The mean effective citalopram dose in the Hispanic group (32.50 mg/day, SD=11.38) was similar to the mean effective dose in the non-Hispanic group (28.00 mg/day, SD=10.95) (Table 2).
Six patients discontinued the study, four because of noncompliance with the treatment protocol and two because of adverse effects. There was no significant difference in ethnicity, age, sex, race, HIV clinical variables, or depression variables between the six noncompleters and the completers.
The groups with and without treatment response differed significantly on several depression variables (Table 1). Patients with treatment response reported a significantly more delayed onset of depression after the diagnosis of HIV seroconversion, compared to the patients without treatment response (t=2.54, df=15, p<0.03). In addition, the patients with treatment response reported a significantly shorter duration of depression, compared to the patients without treatment response (t=–2.41, df=15, p<0.03). Baseline depression severity measures also differed between the treatment response groups. Compared with the patients without treatment response, the patients with treatment response had a significantly lower mean baseline Beck Depression Inventory score (t=–2.22, df=15, p<0.05) and a significantly lower mean baseline Hamilton depression scale score (t=–2.68, df=15, p<0.02). However, the two groups had similar mean baseline scores on the CGI severity scale and the MMSE. Although baseline depression severity and chronicity differed significantly between the two groups, logistic regression analysis revealed that depression severity and chronicity did not correlate with treatment response after the analysis controlled for the effects of demographic and HIV clinical variables, such as disease stage, plasma viral load, CD4 cell count, and use of antiretroviral therapy.
Adverse Effects
Eleven patients (65%) reported treatment-emergent side effects. Two patients (12%) discontinued the study because of adverse events, which included nausea and a rash. The most frequently reported adverse events included insomnia (N=3, 18%), nausea (N=2, 12%), and dry mouth (N=2, 12%). There was no significant difference in the incidence of adverse events between the treatment outcome groups or between the Hispanic and non-Hispanic groups. In addition, HIV clinical variables such as disease stage, degree of immunosuppression, and use of antiretroviral agents were not significantly associated with adverse events. Most adverse events were mild and transient, and no serious events were reported
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DISCUSSION
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Citalopram was found to be effective in the treatment of major depressive disorder in Hispanic and non-Hispanic HIV-seropositive and AIDS patients in this 6-week, open-label study. The efficacy rates of 50% in subjects who completed the 6-week study and 47% in the intent-to-treat group are comparable with the range of efficacy rates for SSRIs in this medically ill population.6,7,27 The mean effective citalopram dose in the intent-to-treat group was 31.25 mg/day (SD=11.11). As reported in most antidepressant studies,4–7 no HIV illness or depression variables were significantly correlated with depression treatment response in this study.
In contrast to studies of tricyclic antidepressants that have found differences in effects between Hispanic and non-Hispanic patients, this study found no differences in the efficacy rate or effective citalopram dose between Hispanic and non-Hispanic patients. These findings of comparable efficacy rates and antidepressant doses between Hispanics and non-Hispanics support the results of studies of the effects of newer antidepressants (i.e., nefazodone and fluoxetine) in Hispanic patients.13,14
Two patients discontinued the study because of adverse events. This 12% discontinuation rate is considerably lower than the 27% discontinuation rate reported in an open-label study comparing the effects of fluoxetine, paroxetine, and sertraline in HIV-infected patients.27 Insomnia, dry mouth, and nausea were the most frequently reported side effects with citalopram. No serious adverse events were reported. Earlier tricyclic antidepressant studies found that Hispanics reported more adverse events than non-Hispanics, but recent studies with the newer antidepressants have not reported this difference.13,14 Similarly, this study found that treatment-emergent adverse events were not more common among the Hispanics. In fact, 50% (six of 12) of the Hispanic patients reported no adverse events during the study.
It is noteworthy that a consistent finding of antidepressant studies of either the tricyclic agents or the newer agents (i.e., fluoxetine, nefazodone) is the significantly higher attrition rate among Hispanic patients.11–14 In this study, Hispanic patients did not have a significantly higher attrition rate, either because of adverse events or because of noncompliance. Seventy-one percent (10 of 14 patients) of the Hispanic patients completed the study, compared to 67% (four of six) of the non-Hispanic patients.
On the basis of the results for this small group of patients, it appears that citalopram is effective in the treatment of depressed HIV-infected patients, regardless of disease stage or Hispanic ethnicity. It is well tolerated and has minimal potential for drug interactions with the antiretroviral medications commonly prescribed in this population.
The limitations of this study include the small number of participants, the open-label format, and lack of a placebo group or a comparison group that did not receive citalopram. Earlier studies have found a higher placebo response rate among Hispanic patients,12,14 highlighting the need for placebo-controlled trials. The power to identify relationships between variables such as ethnicity and treatment outcome in this study was low because of the small number of participants. To our knowledge, this is the first prospective study of citalopram in the HIV-infected population. Larger, double-blind, placebo-controlled studies that include ethnically diverse patients are clearly needed to tease out the relationships of ethnicity with the manifestations of major depressive disorder and with the outcome of treatment.
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ACKNOWLEDGMENTS
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Supported by funding from Forest Pharmaceuticals.
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REFERENCES
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- United States Census Bureau, Public Information Office: Hispanic population reaches all-time high of 38.8 million, new census bureau estimates show. June 18, 2003. (http://www.census.gov/Press-Release/www/releases/archives/hispanic_origin_population/001130.html)
- Centers for Disease Control and Prevention, National Center for HIV, STD and TB Prevention, Division of HIV/AIDS Prevention: HIV/AIDS among Hispanics in the United States. March 11, 2002. (http://www.cdc.gov/hiv/pubs/facts/hispanic.htm)
- Maj M, Jansen R, Starace F, Zaudig M, Satz P, Sughondhabirom B, Luabeya MA, Riedel R, Ndetei D, Calil HM, et al: WHO Neuropsychiatric AIDS study, cross-sectional phase I: study design and psychiatric findings. Arch Gen Psychiatry 1994; 51:39–49[Abstract]
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- Greenblatt DJ, von Moltke LL, Harmatz JS, Shadler RI: Drug interactions with newer antidepressants. role of human cytochromes P450. J Clin Psychiatry 1998; 59(suppl 15):19–27
- Nemeroff CB, DeVane CL, Pollock BG: Newer antidepressants and the cytochrome P450 system. Am J Psychiatry 1996; 153: 311–320
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- Feucht CL, Weissman SB: Psychiatric and antiretroviral agents: associated drug-interactions. T E N 2000; 2:69–73
- Bull SA, Hunkeler EM, Lee JY, Rowland CR, Williamson TE, Schwab JR, Hurt SW: Discontinuing or switching selective serotonin-reuptake inhibitors. Ann Pharmacother 2002; 36:578–584[Abstract]
- Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J: An inventory for measuring depression. Arch Gen Psychiatry 1961; 4:561–571
- Williams JBW: A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry 1988; 45:742–747[Abstract]
- Folstein MF, Folstein SE, McHugh PR: "Mini-Mental State": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12:189–198[CrossRef][Medline]
- Spitzer RL, Williams JBW, Gibbon M, First MB: Structured Clinical Interview for DSM-IV (SCID). New York, New York State Psychiatric Institute, Biometrics Research, 1995
- Yerly S, Perneger TV, Hirschel B, Dubuis O, Matter L, Malinverni R, Furrer H, Perrin L: A critical assessment of the prognostic value of HIV-1 RNA levels and CD4+ cell counts in HIV-infected patients. Arch Intern Med 1998; 158:247–252[Abstract/Free Full Text]
- Centers for Disease Control and Prevention:1993 revised classification system for HIV infection and expanded surveillance case definitions for AIDS among adolescents and adults. MMWR Morb Mortal Wkly Rep 1992; 41(RR-17):1–18
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ABSTRACT
INTRODUCTION
