Novack 2009.

Study characteristics
Methods	Study design: randomised (2‐arm parallel randomised controlled clinical trial) Sample size: 371 Method of randomisation: no information specified Method of concealment: no information specified Blinding: double‐blind Analysis: intention‐to‐treat Date the study was conducted: no information specified
Participants	Location: USA Total N randomised: 99 Intervention n: 49 (79 % male; age M = 35, SD = 17) Control n: 50 (66 % male; age M = 35, SD = 16) Inclusion criteria: within 8 weeks of injury ( = traumatic brain injury); injury sufficient to require inpatient rehabilitation; age 19‐75 Diagnostic criteria ‐ long‐term physical condition: traumatic brain injury: Glasgow Coma Scale (GCS) score of ≤ 12, or neuroimaging results consistent with the effects of trauma (e.g., contusion, subdural hematoma) at admission Diagnostic criteria ‐ depression: diagnosis according to DSM‐IV assessed by SCID‐I Exclusion criteria: existing neurological difficulties; use of antidepressant medication at the time of injury; administration of antidepressant medication in the hospital prior to enrolment; ongoing steroid treatment; depression necessitating treatment at the time of enrolment; pregnancy, alcohol or drug abuse in the year prior to the injury; systemic medical illnesses that would independently limit outcome (such as severe renal disease and cardiac difficulties) History of depression: no
Interventions	Intervention: daily dose of 50 mg sertraline Control: placebo Duration of treatment: 3 months Length of follow‐up: 12 months (3, 6, and 12 months) Other study arms: no
Outcomes	Primary outcome: incidence of depression ‐ diagnosis: diagnosis according to DSM‐IV assessed by SCID‐I adverse events: N/A Secondary outcome: incidence of depression ‐ cut‐off: HDRS cut‐off score ≥ 8; HDRS cut‐off score ≥ 6 (note: we only reported the primary outcome: incidence of depression assessed by diagnosis) severity of depression: NFI cost‐effectiveness: N/A cost‐utility: N/A
Notes	Language: English Funding: National Institute of Disability and Rehabilitation Research Grant H133A980010 Traumatic Brain Injury Model System Project Declaration of interest: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	no information specified
Allocation concealment (selection bias)	Unclear risk	no information specified
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"If depression was confirmed, the blind was broken for the treating physician, but not for the psychometrician performing the outcome assessments" (p. 1923)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"If depression was confirmed, the blind was broken for the treating physician, but not for the psychometrician performing the outcome assessments" (p. 1923)
Incomplete outcome data (attrition bias) All outcomes	High risk	numbers randomised: sertraline: n = 49; placebo: n = 50; total: N = 99 number of drop‐outs at 3 months: sertraline: n = 1; placebo: n = 2; total: N = 3 number of drop‐outs at 12 months: sertraline: n = 13; placebo: n = 14; total: N = 27 numbers analysed post‐intervention at 3 months: sertraline: n = 48; placebo: n = 48; total: N = 96 numbers analysed at follow‐up at 12 months: sertraline: n = 36; placebo: n = 36; total: N = 72 reasons for drop‐out (p. 1926): sertraline: stopped taking study meds, lost or withdrew, O‐Log < 25 or nursing home, adverse events, expired placebo: stopped taking study meds, lost or withdrew, O‐Log < 25 or nursing home, expired
Selective reporting (reporting bias)	Unclear risk	no protocol available
Other bias	Low risk	no