Patel 2013.
Methods | Randomized controlled trial. Randomization method: computer generated list of random numbers. Power: no power calculation reported. Analysis: ITT with LOCF. |
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Participants |
Country: India. Setting: people with HIV in an "outpatient department with symptoms of depression." Recruitment: uncertain recruitment method. Inclusion criteria: PLWH and on ART for ≥ 6 months, aged ≥ 18 years, meeting DSM‐IV criteria for major depression; HAM‐D score > 13; MADRS score > 19. Exclusion criteria: pregnant or nursing women; hypersensitivity to TCAs or SSRIs, previous use of mirtazapine or escitalopram, history of consumption of any psychotropic medication in past 4 weeks, history of seizures, bipolar disorder or other primary psychiatric diagnosis or abnormal laboratory results or serious disease. Failure of previous antidepressant regimens was not an exclusion criterion in this study. Number randomized: 70. Number dropped out: 8 dropped out by 8 weeks (11.4%). Age (mean): escitalopram: 37.9 years; mirtazapine: 36.8 years. Gender: 30 (43%) men. Baseline HAM‐D score (mean): escitalopram: 36 (SD 6); mirtazapine: 38 (SD 7). CD4 T‐cell count: unknown. ART: 100% receiving HAART. Ethnicity: unknown. Socioeconomic details: unknown. |
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Interventions |
Experimental arm: mirtazapine 15 mg once daily (titrated up to 30 mg daily); titrated up from initial dose if improvement < 20% in HAM‐D and MADRS at 4 weeks, downtitrated to 5 mg daily if any adverse effects reported. Comparison arm: escitalopram 10 mg once daily (titrated up to 20 mg daily); titrated up from initial dose if improvement < 20% in HAM‐D and MADRS at 4 weeks, and downtitrated to 7.5 mg daily if any adverse effects reported. Duration: 8 weeks. |
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Outcomes | All outcome assessments were carried out at baseline and 2 weekly assessments for 8 weeks. Primary outcomes:
Secondary outcome:
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Notes |
Date of study: not reported Funding: not reported Declaration of conflict of interest by authors: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated list of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unblinded study but comparison was between 2 known effective antidepressants and not placebo, therefore may not have biased the study outcomes. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unblinded study but comparison was between 2 known effective antidepressants and not placebo, therefore may not have biased the study outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 8 (11%) dropouts all lost to follow‐up (5 in escitalopram group; 3 in mirtazapine group). |
Selective reporting (reporting bias) | Low risk | All relevant outcomes reported. Protocol not assessed. |
Other bias | Low risk | None noted. |