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. 2018 Jan 22;2018(1):CD008525. doi: 10.1002/14651858.CD008525.pub3

Targ 1994.

Methods Randomized controlled trial.
Randomization method: not specified.
Power: not specified.
Analysis: not ITT.
Participants Country: USA.
Setting: unknown.
Recruitment: from local community with newspaper advertisements.
Inclusion criteria: asymptomatic PLWH receiving AZT, meeting criteria (not specified) for major depression or adjustment disorder with depressed mood and score of ≥ 16 on HAM‐D. Failure of previous antidepressant regimens was not an exclusion criterion in this study.
Exclusion criteria: none reported.
Number randomized: 20.
Number dropped out: 2.
Age (mean): 33 years (range 26‐49 years).
Gender: 100% men.
Baseline HAM‐D score (mean): fluoxetine: 20.8 (SD 5.3); placebo: 19.7 (SD 4.0).
CD4 T‐cell count (mean): fluoxetine: 330.2 cells/mm3 (SD 144.7); placebo: 494.5 cell/mm3 (SD 175.8).
ART: all participants receiving AZT.
Ethnicity: 84% white; 16% Latino.
Socioeconomic details: mean 15.5 years of education.
Interventions Experimental arm: fluoxetine 20 mg daily.
Comparison arm: placebo daily.
Adjunctive treatment: structured group therapy including: relaxation techniques training; problem‐solving skills training; didactic presentations; open discussion. 3 psychotherapy groups of 6‐8 participants run by 4th year psychiatry residents. Standardized through weekly supervision.
Duration: 12 weeks.
Outcomes Primary outcomes:
  • improvement in depression: 17‐item HAM‐D (an initial and final 12‐week assessment);

  • number of dropouts.


Secondary outcomes:
  • adverse effects evaluated at 2 weekly intervals: no tool specified.

Notes Date of study: unknown.
Funding: none reported.
Declaration on interest by authors: none.
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 blinded to treatment assignment through use of placebo. Unknown if remaining personnel blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 (10%) participants lost to follow‐up, 1 in each group; unlikely to have a significant impact on results.
Selective reporting (reporting bias) Low risk No evidence. Protocol not assessed.
Other bias Low risk None noted.