Hoare 2014.
Methods | Randomized controlled trial. Randomization method: not specified. Power: sample size (56 participants) calculated to detect a 3‐point difference in MADRS scores at 6 weeks at 5% significance with 20% dropout rate. Analysis: no ITT analysis due to low dropout rate. |
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Participants |
Country: South Africa. Setting: primary healthcare clinics in urban setting referred people to tertiary academic centre where study took place Recruitment: semi‐random convenience sample of consecutively screened people attending primary care ART clinics were referred to an academic hospital to participate in the study. Inclusion criteria: PLWH, aged 18‐65 years, DSM‐IV diagnosis of major depressive episode without psychosis. Exclusion: current/last 6 months DSM‐IV diagnosis of alcohol or substance abuse/dependence; lifetime history of bipolar disorder/schizophrenia, other psychotic disorder, dementia; HDS < 10 and MMSE < 23; positive urine for prohibitive substances or medications such as benzodiazepines. Failure of previous antidepressant regimens was not an exclusion criterion in this study. Number randomized: 105. Number dropped out: 3. Age (median): escitalopram: 34 years; placebo: 34 years. Gender: 15 (14%) men. Baseline HAM‐D score (mean): escitalopram: 20 (SD 5.5); placebo: 21 (SD 5.2) Number on ART: unknown. Baseline CD4 T‐cell count (median): escitalopram: 425.5 cells/mm3; placebo: 350 cells/mm3 Ethnicity: no details. Socioeconomic details: no details. |
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Interventions | After a median of 7 days (range: 4 to 10 days) of single‐blind placebo in both arms. Experimental arm: escitalopram 10 mg. Comparison arm: matching placebo. Duration: 6 weeks. |
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Outcomes |
Primary outcomes:
Secondary outcomes:
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Notes |
Date of study: 2004. Funding sources: Lundbeck South Africa subsidiary of H. Lundbeck A/S, an international, Danish research‐based pharmaceutical company. Declaration of conflict of interest by authors: none. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Semi‐random, convenience sample of consecutively screened participants. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The subjects were randomised to treatment of 10mg per day of either escitalopram or matching placebo for the full 6 weeks of the study." Study personnel and participants were blinded according to author communication. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor was blinded (communication with author). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low dropout rate: "The drop‐out rate was 2.9%. Reasons for loss to follow‐up were unrelated to side effects and all three participants withdrew within the first 2 weeks of the first study visit." Unknown which treatment group these participants belonged to, but unlikely to have a large impact on study results. |
Selective reporting (reporting bias) | Low risk | HADS was not reported in results but was included in the secondary outcomes measures in the study methodology. This was unlikely to have an impact on the overall study outcome as this was not a key measure of depression and all other commonly used scales such as MADRS, HAM‐D and CGI are reported. Protocol not reviewed. |
Other bias | Low risk | None noted. |