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Original papers

The effects of detection and treatment on the outcome of major depression in primary care: a naturalistic study in 15 cities
DAVID GOLDBERG MARTIN PRIVETT BEDIRHAN USTUN GREG SIMON MICHAEL LINDEN
SUMMARY Background. This study reports the responses of patients with confirmed depressive illnesses to different treatments in the WHO Mental Disorders in General Health Care study, conducted in 15 cities around the world. Aim. To discover how depressions recognized by the doctor compare with unrecognized depressions, both in terms of the initial illnesses and their outcomes, and to compare the outcomes of those depressions treated with antidepressants with those treated with daytime sedatives. Method. The design of the study was naturalistic, in that physicians were free to treat patients however they wished. Patients with confirmed depressive illnesses were assigned to four groups: treatment with an antidepressant; treatment with a daytime sedative (usually a benzodiazepine); patients recognized as having depression by the physician but were not offered drug treatment; and patients unrecognized as having depression by their physician. Results. Both groups receiving drugs had illnesses of equal severity, were demographically similar to one another, and had similar previous histories of depression. Those receiving antidepressants had significantly fewer overall symptoms and fewer suicidal thoughts than those treated with sedatives. By the end of one year, differences between the groups had disappeared: patients not given drugs had milder illnesses but did significantly better than those receiving drugs, both in terms of symptoms lost and their diagnostic status. Unrecognized depressions were less severe than recognized depressions, and had a similar course over the year. Conclusions. Patients receiving antidepressants were better in terms of overall symptoms and suicidal thoughts than those treated with sedatives at three months, but this advantage does not persist. Depression emerges as a chronic disorder at oneyear follow-up — about 60% of those treated with drugs, and 50% of the milder depressions, still meet criteria for caseness. The study does not support the view that failure to recognize depression has serious adverse consequences, but, in view of Keywords: depression; primary care; illness recognition; naturalistic study. the poor prognosis of depression, measures to improve compliance with treatment would appear to be indicated.

Introduction
the 15 cities participating in the WHO Study of Mental Disorders in General Health Care. GPs have been criticized for failing to recognize depression,1 and, having recognized it, for failing to treat it energetically enough.2 However, the significance of unrecognized depression in primary care is equivocal, and studies at single centres3,4 have failed to find an association between recognition and outcome, perhaps because recognition does not imply optimal treatment. One US study5 randomized depressed patients to ‘usual care’ or enhanced or ‘multi-faceted care’ (MC). The latter involved greater frequency of visits, two with a psychiatrist. In those with major depression, MC produced greater compliance and greater satisfaction with treatment, with patients rating antidepressants as more helpful and resulting in greater symptom reduction. However, in minor depression, MC produced better compliance but not better outcomes or satisfaction. The present paper studies the natural history of confirmed depressions that were undetected by the doctor, as well as contrasting the course of those episodes of depression treated using antidepressants with those treated using sedatives. The study was naturalistic, in that doctors were free to treat patients however they wished. The design ensured that the depressive illnesses seen were representative of those occurring in general practice, and doctors did not know whether or not a patient they had seen had been identified by the research interview as a case of depressive illness. In spite of evidence of efficacy in controlled clinical trials,6-8 there is lack of information on efficiency; the question being whether, under routine clinical treatment conditions, antidepressants can be shown to influence the course of these disorders. Some recent studies have failed to show a difference between antidepressants and placebos, 9,10 while others have shown equal effects with benzodiazepines,11-13 and others still have shown that psychological treatments are equally effective.14,15 Controlled studies, therefore, need to be supplemented by epidemiological studies on the provision and outcome of treatment. In the present study, GPs frequently reported counselling as one of the treatments given to the patients either on its own or in combination with drug treatment, but the investigators had no control over what was meant by this term. Those patients who did not receive a prescription were therefore called ‘no drugs’, whether or not they were also reported as having received counselling. The aim of the present study was to discover how depressions recognized by the doctor compare with unrecognized depressions, both in terms of the initial illnesses and their outcomes, and to compare the outcomes of those depressions treated with antidepressants with those treated with daytime sedatives. The the effects of interventions general THIS paper examines confirmed cases of depressivebyillness, in practitioners (GPs) in

Sir David Goldberg, FRCP, FRCPsych, professor of psychiatry, Institute of Psychiatry, London. M Privett, MSc, statistician; and B Ustun, project director, Mental Health Division, World Health Organisation, Geneva. G Simon, MD, MPH, psychiatrist, Group Health Co-operative of Puget Sound, Seattle, USA. M Linden, PD, MD, professor of psychiatry, Free University of Berlin, Germany. Submitted: 5 January 1998; final acceptance: 8 July 1998.
© British Journal of General Practice, 1998, 48, 1840-1844.

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British Journal of General Practice, December 1998

Patients were interviewed three months later with a brief set of measures. If the patient was prescribed a drug.17 and subjects were selected for the second interview stage using a stratified sampling procedure. All those prescribed an antidepressant. wishing that one was dead and away from it all. and lower disability scores at baseline (7. • Those treated with antidepressants would do better than those treated with daytime sedatives. or the proportion with a previous episode of depressive symptoms. the number of depressive symptoms on the CIDI. M Privett. = 2. if recognized. were entered in group 3: ‘no drug’. The remaining depressed patients. et al initial hypotheses were: • Depressions treated with drugs would be more severe than those not so treated. Although data was collected on non-pharmacological treatments: these are not presented here. 21 (25. plus a few additional patients who were already on antidepressants. and that depressions recognized by the doctor would be more severe than unrecognized depression.3%) took them for less than one month. d. t = 2.16 Patients satisfying these entry criteria were assigned to one of four groups depending upon whether the GP had recognized them as a psychiatric ‘case’ and.035). lower GHQ scores (Table 3). at one-year follow-up we were limited by the number of patients available for interview at that time. but not taking antidepressants. indeed. with fewer depressive symptoms on the CIDI. plus a few additional patients who were already on these drugs. All those taking benzodiazepines and other anxiolytics. They also had less severe illnesses. but was less for unrecognized patients (significantly fewer [83. It must be emphasized that these were not first onset depressions. Patients said they took the drugs for widely varying lengths of time: for antidepressants. The latter requirement was necessary. or the Diagnostic & Statistical Manual of the American Psychiatric Association (4th edition22). Comparisons between baseline and three months were made for all patients for whom three-month data were available. Original papers sion. and how long they had taken any tablets prescribed. For the purposes of the present study. Four sources of information were used in the present study: 1.6. and were interviewed at length with a full set of measures at 12 months. sex.8. producing a score that varied between 0 and 12 for each subject. The detailed methodology is described elsewhere. as well as having had their symptoms for a shorter period of time. the baseline GHQ scores. and for British Journal of General Practice. were entered into group 1: ‘antidepressants’. a baseline GHQ-28 score. but not prescribed for. In terms of the severity of the depressive illnesses at baseline. and having repeated suicidal thoughts. The Physician’s Encounter Form provided information about recognition of depression and treatment offered. and the episode could have been at any stage at the time of the initial interview. All instruments were translated and back-translated in each of the 11 languages. In order to study the extent to which patients reported suicidal ideas. B Ustun. Consecutive patients eligible for the study completed the 12-item General Health Questionnaire (GHQ). and had a fixed address. were younger and more likely to be male. in which a total of 11 languages were spoken. It was projected that 1500 patients needed to be screened in each centre in order to detect 60 current cases of depression and to have adequate numbers to allow a centre to compare the course of depression relative to other disorders that were common at that centre. In contrast. a score for the four items on the GHQ dealing with such ideas was computed: feeling that life is not worth living. and who were seen on at least one occasion for follow-up assessment.16 Consecutive patients attending clinics at participating centres were approached. were able to communicate. times since first onset of symptoms. just over a third had previous episodes of depres- Results Baseline status It can be seen from Table 1 that there were no significant differences between the two drug groups for age. P = 0. The one-year follow-up provided a full range of outcome measures. P = 0. The CIDI-PC can generate diagnoses using either the International Classification of Disease (10th edition21).f. 4. All those whose mental disorder was recognized by their doctor. patients who were recognized as depressive. were not too ill to participate. 2. They also had less severe illnesses than recognized patients with fewer CIDI symptoms (Table 2). Unrecognized patients were also younger and had their symptoms for less time than recognized patients. were entered into group 4: ‘unrecognized depression’. and only current mental status was considered. The first interview with the patient provided the diagnosis of depression from the CIDI.7 versus 9.1. however.5%. lower scores relating to suicide (Table 5). and • Unrecognized depressions would have a poorer outcome than recognized depressions. whose doctor had rated them as non-cases. but also large differences between one physician and another in what was meant by these treatments. we checked with the CIDI to ensure that the patient told the researcher that the drug was being taken. χ2 = 22. The three-month follow-up provided measures of symptoms experienced. as it was found that there were not only large centre differences.7 weeks. whether a drug had been prescribed. and associated disability were the same for both groups receiving drugs (Tables 2 and 3). as the study used a longitudinal design. were entered in group 2: ‘daytime sedatives’. Length of previous episode was the same for all recognized patients (over 90% of the recognized groups reported previous episodes lasting longer than one month). such that all patients with the highest scores were selected. This paper extends earlier work by examining the effects of recognition and treatment on outcome in a large primary care sample. The present study a reports data on all patients who satisfied diagnostic criteria for current major depressive episode on the CIDI. thinking of the possibility of suicide. including the GHQ-28 and the Brief WHO Disability Questionnaire20 and questions relating to compliance with any treatment prescribed. marital status.00] had such episodes).D Goldberg. These items were scored using Likert scoring. Half of those in an intermediate range and 10% of those in the lowest range were interviewed by a research assistant using the primary care version of Composite International Diagnostic Interview (CIDI-PC)18 and the Groningen Disability Schedule19 shortly after their appointment in the clinic. who said that they were taking it. and indicated whether they were taking the tablets prescribed. providing that they were over 17 years old. and the mean length of time was 10. December 1998 1841 . 3. Method The study involved 15 centres around the world. disability. ‘lifetime’ diagnoses were ignored. and fewer symptoms on the GHQ. but who were not receiving any psychoactive drug.

8 NS t = 3. the ACOVAs for one-year outcome used sex. (NS = not significant. P = 0.3 10. this is not a very powerful test.7 3.62.23 Participation in the follow-up Eighty per cent of the patients with major depression at the baseline assessment completed at least one of the follow-up assessments. 70% for less than a month. or herbal remedy: these substances were taken for shorter periods of time.3.9 13. Baseline characteristics of five groups of depressed patients.15 weeks.9 38.1a 13.2 39. However. (NS = not significant.000a t = 4.6.7 ACOVA NS F = 7. P = 0.4 8. et al Original papers Table 1.4 8. age.6 7. with some centres treating the majority of recognized depressions with antidepressants. P = 0.9 11. The baseline values are compared with t-tests.058 beyond the 5% level.8. NS t = 3. P = 0. 240 at one year) Antidepressants versus sedatives (1 versus 2) Drug versus no drug (1+2 versus 3) Recognized versus unrecognized (1+2+3 versus 4) aSignificant Baseline 17.8 9.6 11.013a F = 3. number of depressive symptoms at baseline.2 36.1 versus 9. bsignificant beyond the 1% level.5.5 ACOVA NS F = 6.004b Male (%) 20. Of the patients who were not prescribed a psychoactive drug. placebo.006b t = 2. and initial GHQ score. vitamin.035a NS Married (%) 48. NS t = 2.9 29.) Group Number of CIDI symptoms Baseline severity Antidepressants (n = 64) Sedatives (n = 49) No psychoactive drugs (n = 120) Unrecognized depression (n = 241) Antidepressants versus sedatives (1 versus 2) Drug versus no drug (1+2 versus 3) Recognized versus unrecognized (1+2+3 versus 4) aSignificant Severity at one year 6.007a ACOVA NS 11. P = 0.6 43. The GHQ scores at three months show that there is a significant advantage for those receiving antidepressants over those receiving sedatives (Table 3).1 18.3 38. Number of symptoms on the CIDI at baseline and one-year follow-up. bsignificant beyond the 1% level. P = 0. at all. there was no difference between the two classes of drug in disability.014a t = 5.8 F = 4.000a beyond the 1% level. P = 0. Table 3.2 15.5.5. NS) 1842 British Journal of General Practice.8 NS c2 = 4.1 NS t = 2. Scores on the GHQ-28 at baseline.9 t = 1. A test of the interaction between centre and management showed that the effects of management were not significantly different between centres. 23 (32. or baseline disability as rated by the SDS or BDQ. The covariates for the ACOVAs were sex. 64 at one year) Sedatives (n = 71.8a P = 0.) Group Antidepressants (n = 85.3 NS NS NS Antidepressants (n = 85) Sedatives (n = 71) No pschoactive drugs (n = 161) Unrecognized depression (n = 323) Antidepressants versus sedatives (1 versus 2) Drug versus no drug (1+2 versus 3) Recognized versus unrecognized (1+2+3 versus 4) aSignificant beyond the 5% level.8 t = –0.1 8.0 16.9a P = 0.2 24.000b Three months 10. so that the relationship between management and outcome of depression was not found to vary between centres. B Ustun.0 6.4 13.5 3. 54% received a prescription for a tonic.2 54.9 56.001b t = 3. and the mean length of time on medication was 9. and initial CIDI depressive symptoms at baseline as covariates.4 7.6. and the mean time was only 5.D Goldberg.034a ACOVA NS ACOVA NS One year 9.3 P = 0. P = 0. Follow-up participation did vary significantly among centres. compared using chi-squared and Student’s t-test. Table 2.2 39.003b Proportion with previous episode (%) 49.8 58.6 5. but was not significantly related to baseline GHQ-28 score.9 P = 0. M Privett. sedatives. and this difference is also seen in the items dealing with suicidal ideas (Table 4).5. However. and at the one-year follow-up. 120 at one year) Unrecognized depression (n = 323. with initial symptom counts as a covariate. as well as sex and age. at three months. while others hardly used these drugs Progress at three months The rate of loss of symptoms over time was tested using analysis of covariance. It was also found that exclusion of subjects with co-morbid disorders produced essentially similar results to those reported here.) Group Mean age 42. December 1998 . 49 at one year) No psychoactive drugs (n = 161.5 NS NS NS Time since first onset (years) 12. There were considerable centre differences in the way in which depression was treated.6 weeks for those given these substances. age.6%) took them for less than one month.6. as measured by the Brief Disability Questionnaire (8.0 P<0. (NS = not significant.1.

5%) 100 (41. as no depressed patients are excluded from the trial by the researchers. Diagnostic status of the four groups at one-year follow-up assessment. It is unlikely that a purely statistical adjustment can fully allow for all the respects in which the groups differed. They were similar to the recognized patients. We were able to make a comparison between antidepressants and daytime sedatives. is also an advantage. all differences had disappeared a year later. and the loss of depressive symptoms on the CIDI were also similar.0 3.5 1. M Privett. P = 0. mean that there were not depressives in that group who would have benefited from treatment. Those patients not receiving drugs did better on both CIDI and GHQ. The data presented here allow a much more complete picture to emerge of the effects of drug use.033a ACOVA NS ACOVA NS One year 2.6 ACOVA NS ACOVA NS ACOVA NS beyond the 5% level. and who therefore contributed to a worse outcome for the treated group. three months. with 48. and the wide variety of cultural settings. confirming the findings with the GHQ.76 F = 4.3%) 12 (24.3%) 8 (16.5%) 47 (39. of course. but the results on the GHQ were equivocal (significantly better at the 10% level).) Group Antidepressants (n = 84. 239 at one year) Antidepressants versus sedatives (1 versus 2) Drug versus no drug (1+2 versus 3) Recognized versus unrecognized (1+2+3 versus 4) aSignificant Original papers Baseline 4.002a NS beyond the 5% level. Discussion This is a naturalistic study. with all its strengths and weaknesses. nor can we know whether the drugs were prescribed in therapeutic doses. daytime sedatives were avoided. It cannot document the efficacy of antidepressants. 48 at one year) No psychoactive drugs (n = 160.71 NS NS t = 1. Furthermore.1 1. as a group.5 3. and.3 NS Sub-threshold 4 (6.4%) 48 (20.9%) 30 (25. they experienced their first symptoms of depression more recently. and their previous episodes of depression lasted for shorter periods of time. there were large centre differences in the drugs prescribed for depression. 120 at one year) Unrecognized depression (n = 321.6. and that the difference between the two groups was not significant.0%) NS P = 0.0%) – – – Continuing case of depression 33 (51.) Another diagnosis 7 (10. one year on. Those patients given drugs can be viewed in the context of others with depression but not given drugs and those not even recognized by the physician.7%) NS c2 = 15.7 1. however.9%) 7 (14. However. Finally.6%) 22 (44.3%) – – – Group Antidepressants (n = 64) Sedatives (n = 49) No drug (n = 240) Unrecognized (n = 240) Antidepressants versus sedatives Drug versus no drug Recognized versus unrecognized aSignificant Well 20 (31. both in terms of disability scores at one year and diagnostic status.2%) 68 (28.3%) were still either cases of depression or cases of another mental disorder.7 3.3%) 13 (10. while in others.D Goldberg. although the generally good outcome for the whole group suggests that this cannot be thought a major problem. Patients with unrecognized depressions also lost symptoms on both the CIDI and GHQ and had similar reductions in disability as patients with recognized depression. et al Table 4. and one-year-follow-up. B Ustun. all cases of depression were confirmed by independent interview. Table 5 shows the diagnostic status of patients at one-year follow up: it can be seen that about 60% of both groups receiving drugs were still ‘cases’ of mental disorder one year later.9%) 24 (10. not all the patients were available at the one-year follow-up — although those not followed up were in no way different from those whose results we report here.3%) 29 (24.8. The longitudinal design lasting a year. Conclusions Recognized versus unrecognized depression Unrecognized cases of depression in primary care have. or refused to collaborate with a therapeutic trial. Patients who were not prescribed drugs lost their symptoms to the same extent at three months. there are some undoubted British Journal of General Practice.7 5. In some centres. but were similar to the drug group in terms of their disability scores. Our failure to show that non-recognition of depression has serious measurable effects does not. (NS = not significant.5 2.7 2. 64 at one year) Sedatives (n = 70. December 1998 1843 . P = 0. it is not more likely to still be suffering from depression. even after adjustment for initial scores on each instrument.07 Three months 2. such patients may possibly be hidden by detected patients who did not benefit from treatment. or indeed whether the patients who said they were taking drugs really were doing so. had similar scores on suicide. as use of the latter was so widespread in some of the centres that comparable groups in terms of severity and baseline characteristics were available. Finally. Table 5. The fact that almost half of the unrecognized cases (48. and were equal in terms of disability reduction. Against these shortcomings.3% still regarded as ‘cases’. Patients with depressions that were unrecognized by the doctor lost their symptoms on the CIDI at a similar rate to recognized depressions. (NS = not significant. antidepressants were hardly ever used. Outcome at one year For the two classes of drug. suggests that efforts to improve the ability of doctors to detect depressive illness are worthwhile. less severe illnesses in a number of important respects: they have fewer symptoms of depression. the group as a whole does better than the recognized cases. strengths. Suicide scores on GHQ at baseline.

It is known from other studies24 that chronic depression is associated with severe social and interpersonal problems. 310: 441-445. recognition. Quitkin FM. A multi-faceted intervention to improve treatment of depression in primary care. Madonia MJ. when compared with those treated with sedatives.bpmf. Ir J Med Sci 1989. Williams P. Robinson P. Diagnostic and Statistical Manual of the American Psychiatric Association. A multi-centre double blind comparative trial of fluvoxamine versus lorazepam in mixed anxiety and depression treated in general practice. Supported by grants from the World Health Organisation. Depression Guideline Panel. but we have seen that they appear to be being given to patients with the most severe illnesses. Goldberg DP. Laws D.D Goldberg. Psychological Disorders in General Medical Settings. At one year. R Florenzano and H Acuna in Santiago de Chile. The finding that patients with less severe illnesses had a better outcome should cause no surprise. 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The findings suggest that a future trial of efficacy might address the advantages of ways of improving compliance with treatment protocols over the longer term. London: Routledge. von Korff M. BMJ 1995. and confined our analyses to those patients who started out on their assigned drug. 1994. Am J Psychiatr 1996. Int J Rehab Res 1988. RCT comparing problem-solving treatment with amitryptiline and PBO for depression in primary care. Washington: American Psychiatric Association. 81(2): 185-189. Washington: US Dept of Health and Human Services. 17. Arch Gen Psychiatr 1988. 11. R Gater and S Kisely in Manchester. Chichester: John Wiley. Ormel J. Koeter M. 15. et al Drugs versus no drugs Depressive patients who were not treated with drugs had lower GHQ scores and fewer depressive symptoms reported on the CIDI than those given drugs. we have no way of knowing the extent to which dosage was adequate. Wiersma D. Goldberg DP. Stewart AL. Depression in Primary Care. 4. Y Nakane and S Michitsuji in Nagasaki. Agency for Health Care Policy and Research. Wing JK. 5. Paykel ES. Tomlinson D. Banerji JR. et al. and this is appropriate in view of the better outlook of the milder illnesses being managed without psychoactive drugs. Ashford JJ. Address for correspondence Sir David Goldberg. 10. and M Tansella and C Bellantuono in Verona. 1993. 14: 83-95. 53: 913-919. those more severe depressions treated with antidepressant drugs may benefit from longer periods of treatment. Simon GE. 53: 924-932. 1990. Recognition. 8. Simon GE. Heathcote D. The generally very poor outcome for the treated groups at oneyear follow-up — about 60% were still psychiatric cases — may reflect the generally poor outcome of more severe illnesses. 125: 186-192. 1995. O Benkert and W Maier in Mainz. et al. our findings need to be considered in the context of the study design — we identified patients on an ‘intention to treat’ basis. However. Occurrence. World Health Organisation. 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Antidepressants versus daytime sedatives The data indicate that those depressions treated with antidepressants had fewer general psychiatric symptoms.