Rabkin 1994.

Methods	Randomized controlled trial. Randomization method: not stated. Power: sample size calculation not stipulated. Analysis: no ITT analysis conducted.
Participants	Country: USA. Setting: not stipulated. Recruitment: method unknown. Inclusion criteria: aged 18‐65 years; PLWH, DSM‐III‐R major depression, single or recurrent, with or without dysthymia, minimum HAM‐D score ≥ 14; medically stable; white cell count > 2000 cells/mm3, platelet count > 60,000 cells/mm3, haematocrit > 30%. Exclusion criteria: substantial suicide risk, previous treatment with imipramine ≥ 150 mg during current illness episode; substance abuse in past year, schizophrenia, schizoaffective disorder, bipolar mood disorder, dementia as assessed by modified‐MMSE, imipramine contraindicated. Failure of previous antidepressant regimens was not an exclusion criterion in this study. Number randomized: 97. Number dropped out: 17 (18%). Age (mean): study completers: 38 years; study dropouts: 37 years. Gender: 92 (95%) men. Baseline HAM‐D score (mean): 17.5 (SD 4.1). Number on ART: study completers: 53 (66%); study dropouts: 9 (53%). CD4 T‐cell count (mean): study completers: 301 cells/mm3 (SD 202); study dropouts: 341 cells/mm3 (SD 258). Ethnicity: white: 81, Hispanic: 8; black: 8. Socioeconomic details: full‐time employment: 55; part‐time employment: 11; disability grants: 14; unemployed: 16.
Interventions	Experimental arm: imipramine initiated at 50 mg and increased in 50 mg increments to 200 mg at 4 weeks and up to 300 mg after week 4 if poor clinical response. Dispensed weekly. Comparison arm: matching placebo. Duration: randomized assignment continued for 6 weeks. After 6 weeks, blind was broken for treatment non‐responders. All were followed up for up to 26 weeks.
Outcomes	Primary outcomes: improvement in depression: 21‐item HAM‐D score, CGI score, BSI, Beck Hopelessness Scale measured at baseline; 6, 12, and 26 weeks; and study termination; number of study dropouts. Secondary outcomes: immunological recovery: T‐cell measurements, measured at baseline; 6, 12, and 26 weeks; and study termination; adverse effects: measured at baseline and 6 weeks using SAFTEE.
Notes	Date of study: enrolment commenced 1989. Funding: NIMH grant MH‐45652; imipramine and matching placebo supplied by Ciba‐Geigy corporation. Declaration of conflict of interest by authors: not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants were blinded: "...patients were randomly assigned to imipramine or matching placebo..." "After 6 weeks the blind was broken for nonresponders, while responders where maintained double‐blind for an additional 6 weeks." Unknown whether personnel were blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	18% dropouts, evenly distributed between study arms. Baseline characteristics were similar between dropouts and study completers. A greater number of participants on imipramine dropped out due to adverse effects (n = 7) as compared to those receiving placebo (n = 4), this is unlikely to have affected the assessment of the primary outcome.
Selective reporting (reporting bias)	High risk	CGI scores not tabulated with other rating scale results although stipulated as an outcome in the methodology it was only reported as a composite with HAM‐D as 'responder' or 'non‐responder.'
Other bias	Low risk	None noted.