| Purpose:1 This study was conducted to determine the efficacy and tolerability of citalopram hydrobromide in treating depressive symptoms in advanced cancerpatients.2 This study was conducted to determine whether citalopram hydrobromide improves overall quality of life (QOL) in advanced cancer patients with symptoms of depression.Methods:A randomized,double blinded,citalopram and placebo parallel controlled study,Cases all from guangzhou medical college affiliated tumor hospital , all accurate diagnosis cases are malignant tumors by pathological diagnosis, and patients with an expected survival more than 3 months, the recruited oncology patients who presented for psychiatric evaluation and fulfilled the criteria: 17-item Hamilton Rating Scale for Depression (HAM-D-17) score≥14, With the standard and voluntarily participate in the experiment of patients Concomitant anticancer and supportive treatments were given according to standard local practice. Patients were then randomly assigned in a double-blind manner to receive either citalopram (20-mg tablets) or an identical placebo tablet. The randomization was performed through a preprinted randomization table , The study drug was self-administered by the patient once daily in the morning for 6 weeks. Longitudinal assessments were performed at baseline and every 1,2,4 to 6 weeks thereafter and included the measurement of each index. Depression and anxiety were evaluated by the Hamilton Depression Scale (HAM-D-17) and Hamilton Anxiety Scale (HAMA), Quality of life was evaluated by QLQ-C30, version3 Clinical global impression (CGI) was used to give a global judgement about the severity of psychological illness and to assess the changes in illness degree compared to the previous evaluation.The Treatment Emergent Symptom Scale (Tess) were used to assess the safety. A physical examination and clinical laboratory( blood, urine and kidney function and ECG examination )profile were performed at visit 1 and again at discontinuation.. The significance of the clinical improvements was evaluated on the basis of collected data and all tests performed were two-tailed at the 5% level of significance.Results:1. Between November 2007 and February 2008, 188 adult hospitalized patients with advanced, incurable malignancy were enrolled. The citalopram arm 95 cases (lost 7 patients), The placebo arm 93 cases (lost 5 patients). Patients in each study arm were comparable at baseline with respect to age, sex, performance status, symptom status and depression, disease distribution, and current treatment(P>0.05).2.At 1 week, HAM-D-17 scores in both Citalopram treatment group (16.62±3.48) and the control group (17.04±3.43) were improved, but there were no significant differences (P > 0.05) between the two groups. At the treatment of 2, 4, 6 weeks, HAM-D-17 scores in both arm There have significant difference (P < 0.05).The rate of effectiveness,based on the percentage decrease of HAM-D-17 is 62.2%in the citalopram group.and 41.1%in the placebo group ,there have significant difference(P < 0.05).3.At 1 week, the HAMD-17 score decreased from baseline by 2.40±1.51 in the citalopram group,and 1.86±1.31 in the placebo group.There have no significant difference between the two groups (P > 0.05).Citalopram treatment group had remarkable improvement in anxiety evaluated by HAMA (score from 16.61±3.54 to 7.93±3.14 at 6 week),and placebo treatment group in anxiety evaluated by HAMA (score from 16.77±3.95 to 10.51±5.06 at 6 week) there have significant difference between the two groups (P < 0.05).4.The QOL in each study arm were comparable at baseline evaluated by QLQ-C30,version3.There have significant difference between the two groups in Global quality of life,role functioning,emotional functioning,cognitive functioning,fatigue,sleep disturbances at 4,6 week. but in role functioning,cognitive functioning and fatigue the median difference is less than 10 points, According to the standard recommend by Osoba etc, Therefore no clinical significance between the two groups. The field before and after treatment there were no significant differences.5.CGI severity of illness scores evaluation scales indicated that Patients in each study arm were comparable at baseline, and there have significant difference between the two groups (P < 0.05) at study endpoint.CGI global improvement scores also decreased during the course of the study indicating an improvement at endpoint. There have statistically significant differences between the two groups in CGI curative index at endpoint(P<0.05).6.In total, 28(31.1%) patients in the citalopram group compared with 23 (25.3%) patients in the placebo group reported at least one adverse experience there were no statistically significant differences between two group .The main research combined medication was 9 patients in the citalopram group (10.0%) and 11 patients in the placebo group (12.8%) there were no significant differences. Conclusions:In this mix of patients with advanced cancer who had symptoms of depression as determined by a HAMD-17 survey, use of citalopram was well tolerated, overall QOL was improved, and depressive symptoms were reduced.
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