Study design | Randomised, double-blind, placebo-controlled clinical trial | Single-blinded, open clinical trial | Randomised, double-blind, placebo-controlled clinical trial | Randomised, double-blind, placebo-controlled clinical trial |
Participants | 27 adult COPD patients with BDI sum scores of ≥15 points without severe depression (19 completed) | 57 COPD outpatients (stages II–III) and depression according to GMS scores (≥3) (7 completed) | 23 COPD outpatients (mean stage III) and a GDS sum score of ≥11 points (15 completed) | 28 COPD outpatients (stages II–III) and depressive disorders according to ICD-10 criteria |
Interventions | 12-week treatment with citalopram (20 mg·day−1; increase to 40 mg at week 6, if tolerated) or placebo | 6-month treatment with fluoxetine (20 mg·day−1) | 12-week treatment with paroxetine (2 patients: 10 mg·day−1; 6 patients: 20 mg·day−1) or placebo | 6-week treatment with paroxetine (20 mg·day−1) or placebo; then, unblinded application of paroxetine (20 mg·day−1) for 3 months |
Outcomes | Response to treatment at weeks 6 and 12 as assessed by the HDRS | Sum scores for the MADRS at baseline, 6 weeks and 3 months | Sum scores in the GDS at final follow-up (in regular cases week 12) | Sum scores in the HADS, BDI, MADRS and SGRQ; 6-min walk test |
Main results | No significant group difference, but stronger antidepressant effects of citalopram in cases of mild-to-moderate depression | 4 out of 7 who completed also responded to fluoxetine, 5 patients dropped out due to adverse side-effects of fluoxetine | Significant antidepressant effects of paroxetine (in contrast to placebo); no significant group difference in GDS outcome | No significant group difference after 6 weeks; significant improvement after 3 months (HADS-D: Cohen’s d 1.33#) |
Randomisation method | No information available | No | Random numbers table | No information available |
Manufacturer support | No information available | No information available | No | No information available |
Verified COPD diagnosis | No information available | Yes | Yes | Yes |
Depressive episodes in the past | No information available | Yes, previous diagnosis for depression led to exclusion | No | Yes, previous diagnosis for depression led to exclusion |
Family history of affective disorders | No information available | No information available | No | No |
Assessment of core symptoms of depression | No | No | No | No |
Compliance assessment | No information available | No information available | Yes, by pill count | Yes, by pill count |