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Impersistence of Depression in Youth: Implications for Drug Study Design

From the Department of Psychiatry at Drexel University College of Medicine and Philadelphia Health & Education Corporation, Philadelphia, Pennsylvania (Dr Malone, Dr Bennett, Dr Delaney); Columbia University, New York, New York (Dr Choudhury); Wordsworth Academy in Ft. Washington, Pennsylvania (Dr Luebbert); and Biomedical Statistical Consulting, Wynnewood, Pennsylvania (Dr Cater).

	ABSTRACT

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Food and Drug Administration data show that most anti-depressant studies in youth do not show drug effect. The few positive studies used rigorous diagnostic screening procedures, suggesting major depressive disorder (MDD) may not be a persistent condition in a subgroup of youth. To investigate persistence of MDD, we serially assessed a cohort of inpatients admitted to the hospital with a clinical diagnosis of MDD. Assessments included a structured diagnostic interview, the Diagnostic Interview for Children and Adolescents-Revised (DICA-R), and measures of depressive symptomatology. Of 66 subjects (40 girls; mean age, 14.4 ± 2.2 years), 34 (51.5%) met DICA-R criteria for MDD at the initial postadmission assessment. Of these, only 8 (23.5%) met DICA-R criteria for MDD at any subsequent assessment. Similar reductions were found on other ratings of depression. In conclusion, MDD did not persist in this sample. The findings suggest a multigated assessment procedure should be employed before randomization in antidepressant clinical trials.

Key Words: Depression • adolescents • study design

The purpose of this study was to prospectively assess the short-term continuity of major depressive disorder (MDD) and depressive symptoms in hospitalized children and adolescents. If MDD is somewhat transient among a fairly large number of youth, then drugs that require weeks or months to reach potential clinical effect will have difficulty showing a benefit compared to placebo, especially if the patients' symptoms have a high likelihood of improving regardless of treatments.

	MATERIALS AND METHOD

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Setting
The setting for this study was an acute care child and adolescent psychiatry inpatient service located in a tertiary care medical center. All patients on the service also received other treatments including individual, group, family, and milieu therapy. In addition, 19 patients received medication as determined by clinician choice. This study received approval from the Drexel University College of Medicine Institutional Review Board.

Subjects
Inclusion criteria for the study included (1) a clinical diagnosis of MDD as assigned by the attending psychiatrist at admission, and/or (2) an actual suicide gesture that led to the hospitalization, and (3) age of 9 to 17 years. Excluded were children meeting criteria for mental retardation (Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition [DSM-III-R]).⁹

There were approximately 600 consecutive admissions over the 3-year period that data were collected. Of these, 66 children (26 boys and 40 girls), ranging in age from 8.9 to 17.8 years (mean, 14.4 years; SD, 2.2 years), met the inclusion criteria for the study. Subjects included 37 (56.1%) African Americans, 15 (22.7%) Hispanic Americans, 11 (16.7%) European Americans, and 3 (4.5%) classified as "other." The majority of patients admitted to the unit were from families who were Medicaid recipients. Of the 66 subjects, 23 (34.8%) entered the study with a clinical diagnosis of MDD, 31 (47%) had both a clinical diagnosis of MDD and a suicidal gesture, and 12 (18.2%) had a suicidal gesture alone.

Measures
Diagnostic Interview
Diagnostic Interview for Children and Adolescents-Revised (DICA-R).¹⁰ The DICA-R is a structured clinical interview for children and adolescents developed to assess DSM-III-R Axis I diagnoses, including MDD. The DICA-R-C (child version, ages 7 to 12 years) or the DICA-R-A (adolescent version, ages 13 to 17 years) was administered. The interviewers were all trained administrators of the DICA-R. Interrater agreement was high ( = 1.00 on a subsample of 10 subjects, 6 of whom were rated as meeting criteria for MDD and 4 who were rated as not meeting criteria for MDD). High 1-week test-retest reliability has been reported on the depression section of the DICA-R in adolescents.¹¹ This version was employed because the DSM-III-R was in use at the time the study was initiated.

Symptom Ratings
Hamilton Rating Scale for Depression-Modified (HAM-D).¹² The 21-item HAM-D was employed to obtain clinician ratings of depressive signs and symptoms. The interviewers were all trained in the HAM-D. Interrater agreement was high (Pearson correlations ranged from r = .94 to r = .96, n = 43, for the different assessment times).

Beck Depression Inventory-Short Form (BDI).¹³ The 13-item BDI was employed for this study to assess symptoms of depression. The BDI has demonstrated validity in youth, including items from the short form.¹⁴

Children's Depression Inventory (CDI).¹⁵ The CDI is a 27-item self-report questionnaire based on the BDI and was designed to assess symptoms of depression in children. The CDI has satisfactory reliability and validity.¹⁶

Procedure
Children and adolescents who met inclusion criteria were assessed for MDD using the MDD module of the DICA-R at the following time points: day 1, week 1, and week 2. Depressive symptoms were assessed using the HAM-D, BDI, and CDI at the same time points, as well as at 3 days after admission (day 3).

Data Analysis
A generalized estimating equation (GEE) logistic regression¹⁷ was used to examine continuity in the number of subjects meeting criteria for MDD over time. Repeated measures analysis of variance (ANOVA) was conducted to examine continuity in dimensional measures of depressive symptoms over time for each outcome measure. Analyses were performed for the total sample (N = 66) and the subset of subjects meeting criteria for MDD on day 1 (n = 34). Data for this subset are presented separately because one of the goals of this report was to examine whether children who initially met criteria for MDD continued to meet criteria for the diagnosis over time in the inpatient setting. Furthermore, to examine medication status and its relation to short-term symptom status, stratified analyses by medication status were performed on the total sample and those meeting MDD criteria on day 1. Tukey-adjusted post hoc tests were used for pairwise comparisons between time points for all ANOVA analyses. Finally, Pearson correlation coefficients were used to examine the stability of depressive symptoms over time.

	RESULTS

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Continuity of MDD Diagnosis
Entire sample (N = 66). Of the 66 subjects, 34 (51.5%) met criteria for MDD on the DICA-R at day 1, 4 subjects (6.1%) at week 1, and 7 (10.6%) at week 2. This finding represents a significant decrease in the number of subjects meeting criteria for MDD across time (GEE logistic regression, overall P < .0001; day 1 vs week 1, P < .0001; day 1 vs week 2, P < .0001; week 1 vs week 2, P = .260). Gender, age, and race were unrelated to meeting criteria for MDD on day 1. Furthermore, meeting criteria for MDD on the DICA-R at day 1 was unrelated to having recently made a suicide gesture.

Subsample: subjects who met DICA-R criteria for MDD on day 1 (n = 34). Of the 34 subjects who met criteria for MDD on day 1, 26 (76.5%) did not meet criteria for MDD on any repeat administration of the DICA-R, indicating a significant decrease (McNemar test, P < .0001). Only 2 subjects (5.9%) additionally met DICA-R criteria for MDD both at weeks 1 and 2. In addition, 2 subjects (5.9%) met DICA-R criteria for MDD at week 1 but not at week 2, and 4 subjects (11.8%) also met criteria at week 2 but not at week 1.

Continuity of Depressive Symptoms
Total sample (N = 66). Table II presents the mean HAM-D, BDI, and CDI scores for the entire sample at each assessment. Repeated measures analyses of variance (using SAS PROC MIXED with an unstructured covariance matrix) showed that the HAM-D, BDI, and CDI scores each decreased significantly across time during hospitalization for the overall sample. Tukey-adjusted post hoc tests for the HAM-D showed significant decreases between day 1 versus day 3, day 1 versus week 1, day 1 versus week 2, and day 3 versus week 2. For the BDI, significant decreases were found between day 1 versus day 3, day 1 versus week 1, and day 1 versus week 2. Likewise, CDI scores decreased significantly between day 1 versus day 3, day 1 versus week 1, and day 1 versus week 2, and day 3 versus week 2. The depression ratings across time were significantly higher for the subgroup that met DICA-R criteria for MDD on day 1 than for those who did not for each measure: HAM-D (F_1,90 = 35.8, P < .0001), BDI (F_1,186 = 13.5, P = .0003), and the CDI (F_1,188 = 24.9, P < .0001).

Subsample: subjects who met DICA-R criteria for MDD on day 1 (n = 34). As for the entire sample, the scores for each rating scale decreased significantly across time for this subsample (Table II). Post hoc analyses showed significant drops in HAM-D scores between day 1 versus day 3, day 1 versus week 1, day 1 versus week 2, and day 3 versus week 2. For the BDI, significant decreases also occurred between day 1 versus day 3, day 1 versus week 1, and day 1 versus week 2. Likewise, CDI scores decreased significantly between day 1 versus day 3, day 1 versus week 1, and day 1 versus week 2.

MDD and Clinical Medication Status
As noted above, medication was prescribed by clinician choice. Receiving medication was unrelated to change in reported symptoms on the BDI and CDI for the entire sample (Table III). However, for the HAM-D, the main effect of medication status was significant (F_1,190 = 7.65, P = .006), as those in the medication group had higher scores compared to the no-medication group. The interaction of time and medication was also significant (F_3,190 = 3.12, P = .027), with differences between the no-medication and medication groups found for day 1, day 3, and week 1, but not week 2. For each measure, there was a statistically significant decrease in scores over time for youth who were medicated.

Similar results were found for the subset of subjects who met DICA-R criteria for MDD on day 1 (Table IV), in that medication status was generally unrelated to change in reported symptoms for the BDI and CDI. For the HAM-D, the main effect of medication status and its interaction with time just missed significance (F_1,94 = 3.32, P = .072 and F_3,94 = 2.57, P = .059, respectively). Gender, age, and race were unrelated to medication treatment status.

Stability of Depressive Symptoms
Entire sample (N = 66). Correlation coefficients for the stability of HAM-D across time were as follows: day 1 to day 3, r = .71; day 1 to week 1, r = .72; day 1 to week 2, r = .40; P .001 for each. For the CDI, correlation coefficients were day 1 to day 3, r = .75; day 1 to week 1, r = .69; day 1 to week 2, r = .49, P .001 for each. Correlation coefficients for the BDI were day 1 to day 3, r = .65, P .001; day 1 to week 1, r = .55, P .001; day 1 to week 2, r = .37, P .05. Thus, although depressive symptoms decreased markedly during the study period, there was significant stability in their rank-ordering.

Subsample: subjects who met DICA-R criteria for MDD on day 1 (n = 34). Similar stability was observed among the subsample of youth with MDD. Correlation coefficients for the stability of HAM-D across time were as follows: day 1 to day 3, r = .71, P .001; day 1 to week 1, r = .70, P .001; day 1 to week 2, r = .34; P .05. For the CDI, correlation coefficients were day 1 to day 3, r = .67, P .001; day 1 to week 1, r = .60, P .001; day 1 to week 2, r = .44, P .05. Correlation coefficients for the BDI were day 1 to day 3, r = .62, P .001; day 1 to week 1, r = .47, P .05; day 1 to week 2, r = .49, P .05.

	DISCUSSION

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Employing a naturalistic design, this study investigated the short-term continuity of MDD and depressive symptoms in hospitalized children and adolescents. Overall, MDD and depressive symptoms were not continuous during the 2-week study period. Although 34 subjects met criteria for MDD 1 day after admission, 26 (76.5%) of them did not meet criteria for a diagnosis of MDD on any repeat administration of the DICA-R. Moreover, only 2 of these 34 subjects (6%) continued to meet criteria for MDD at both subsequent assessments.

Depressive symptom ratings also decreased significantly during the 2-week study period as measured by the clinician rated HAM-D and the self-reported BDI and CDI. The greatest decrease was observed in the first week, particularly within the first few days of hospitalization. Although depressive symptoms were not continuous, stability for symptoms was found to be present over the 2 weeks, as indicated by the consistency in rank-ordering of symptoms across children. In addition, the continuity of MDD and of depressive symptoms was not generally related to whether children received medication, except for the HAM-D at some time points.

Why did MDD diagnoses and depressive symptoms decrease significantly during the first week of hospitalization in the present sample? A likely explanation for the decrease in reported symptoms involves the possible effect of the environment on depressive symptoms in children and adolescents. Because this study was conducted in an inpatient setting, the decrease in symptoms seen in these inpatients may be attributable to a change in setting from home to hospital. Children and adolescents may be susceptible to environmental and psychosocial circumstances, perhaps to a greater degree than are adults, such that with a change in these factors, symptoms remit.¹⁸

Second, subjects tend to present for assessment at a time of crisis, and it is possible that symptoms would have decreased whether or not they received treatment. Such a "regression to the mean" interpretation is plausible and cannot be ruled out. Nonetheless, if symptoms had decreased without treatment, this would still suggest that depressive symptoms are not continuous over a short period of time among a sample of acutely depressed youth.

	IMPLICATIONS

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Our findings have important implications for clinical treatment and research. Children and adolescents may have transient symptoms that fulfill criteria for MDD, particularly when presenting for treatment. Our data indicate that many children and adolescents diagnosed with MDD report fewer depressive symptoms within a short period of time without medication treatment. Hence, in studying children and adolescents with depression, it may be best to employ a multiple-gated entry procedure, selecting patients who maintain both the diagnosis and high level of symptoms on depressive ratings on at least 2 different ratings done at least 1 week apart. In drug-treatment studies, drug effect is assessed by comparing the response of patients who are randomized to active drug compared to the response of patients randomized to treatment with placebo (under double-blind conditions). Ideally, patients do not have a condition that remits spontaneously so that drug/placebo comparisons reflect only drug effect, not the potential effect of spontaneous remission in members of both groups. If there is a high rate of spontaneous remission, it is hard to show that drug treatment is effective. Not only does drug treatment have to be effective, but also it has to be more effective than the rate of spontaneous recovery to demonstrate that drug treatment is better than placebo. Establishing a continuous baseline of symptoms before randomizing subjects may correct for the high placebo response rate found in previous clinical trials of antidepressants in children and adolescents,^2,19-22 particularly among those with relatively short durations of their depressive episode.²³

Delaying drug treatment as long as possible seems a prudent step clinically as well. Symptoms may dissipate without drug treatment, but once initiated, drug treatment may be administered on a long-term basis. Without careful assessment, it is possible that a number of children will be exposed to long-term drug side effects unnecessarily. Antidepressants are increasingly prescribed in children,²⁴ and approximately half of the children evaluated as depressed by physicians receive antidepressants.²⁵ At times, of course, clinical circumstances may dictate that medication treatment be initiated soon after initial assessment. Given the cyclical nature of MDD and its significant relapse rates,²⁶ children who have not responded to nonpharmacologic therapies during a previous episode may be good candidates for antidepressant drug treatment. However, the lack of short-term continuity of symptoms found in this study suggests that alternatives to medication deserve consideration. For example, psychosocial interventions such as cognitive behavior therapy²⁷ and interpersonal therapy²⁸ have been found to be effective with depressed children and adolescents. These recommendations are consistent with practice parameters suggesting that psychotherapy be used as the first treatment for most depressed youth.^29,30

Limitations
Several limitations of this study should be noted. First, as a naturalistic study, it was not possible to verify the causes of symptom reduction. Furthermore, some symptom reduction may have been related to the inpatient setting, which could reduce stressors related to symptomatology and provide therapeutic intervention. Also, patients may have underreported symptoms, thinking it would lead to hospital discharge. Regardless, this does not detract from the recommendation of having multiple evaluations before initiating treatment. In any setting, symptoms may vary with exposure to stressors and motivation, and these stressors may increase or decrease over time, resulting in changes in some symptoms. Second, as the study was conducted with inpatients, the findings may not generalize to outpatients. Third, we did not have input from other sources such as parents and teachers to assess depressive symptoms. Such aggregation of child and parent interview data may enhance the validity of depression assessments.³¹ The parents did not spend extensive time with their child during hospitalization, and parents were not in a position to report subtle changes in their child's symptoms over the 2-week period and were thus not used as raters in the present study. Furthermore, research has shown that parents may underreport depressive symptoms^32,33 and that children are valid raters of their depressive symptoms.^34,35 Finally, our study had no posthospital follow-up. It is important to know if and when children's depressive symptoms recur. If symptoms dissipate in the hospital but recur very soon after discharge, it would suggest that environmental factors are closely related to symptoms.

Further studies investigating the short-term continuity of MDD and depressive symptoms in children and adolescents are needed. As noted, studies following youth in the first few days and weeks after discharge are needed to document whether symptoms increase once children are back in their natural environment. Although it is often assumed that continuity of depressive symptoms depends on intrinsic factors, we must also consider the presence of continuity of adverse environments, including those to which the depressed youth is returning.³⁶ This information is crucial for assessing treatment response both within the context of clinical trials and with clinical treatment.

This work was supported in part by USPHS Grant MH-00979 (Dr Malone).

DOI: 10.1177/0091270006290334

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