Grenyer 2007.

Study characteristics
Methods	Randomised controlled parallel‐arm trial, 16 weeks
Participants	Participants: 83 outpatients from Northfields Clinics, University of Wollongong, Australia, mean age 45.3 (range 18 ‐ 70) years, 51 women, dates ‐ not reported. Comorbidities: Yes in some participants: anxiety (54%), personality disorder (57%) Adjunctive therapy: Yes in some participants: 74% currently taking therapeutic doses of antidepressants Inclusion criteria: aged 18 ‐ 75 years, SCID DSM‐IV primary diagnosis of MDD, HDRS > 16 Exclusion criteria: serious medical condition, non‐consent for venipuncture, comorbid substance abuse, psychotic, bipolar, OCD or eating disorder
Interventions	Intervention: EPA/DHA combination (tuna fish oil providing 2.2 g/d DHA, 0.56 g/d EPA, plus 80 mg vit E), 8 x 1 g capsules, plus ongoing therapy Comparator: Olive oil, 8 g/d, 8 x 1 g capsules per day, plus ongoing therapy Treatment received for 16 weeks
Outcomes	Primary: HDRS, BDI ‐ baseline, 3 week intervals until 16 weeks, Adverse events Secondary: GAF, Likert scales of aches/pains, energy, fatigue, sleep, appetite; Trial non‐completion
Notes	Funded by Clover Corporation Plc, Australia, University of Wollongong, Australia, and the Australian Research Council Supplements provided by Clover Corporation Plc, Australia Conflict of Interest: Not reported Compliance: Fortnightly capsule counts, EPA and DHA in RBC membranes, plasma cholesterol and alpha‐tocopherol at baseline, 6 weeks and 16 weeks Depressed mood (continuous): Analysis conducted on HDRS (17‐item) scores at 16 weeks, ITT data provided by authors Adverse events: Only prespecified adverse events are reported. ~⅓ of sample noticed changes in stools due to capsules across both groups. Only significant differences between groups also reported (belching, noticeable aftertaste in the mouth and breath), but no values. Data could not be included in analyses Quality of life: GAF measured, but no data available Trial non‐completion: Interventon group = 8, comparator group = 15. Reasons ‐ 8 time/commitment, 4 moved away, 3 hospitalised, 2 time constraints, 6 lost to follow‐up (reasons not split by group)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"urn randomisation balanced _ on _ prognostic factors of age, sex, therapy, HDRS score" (P.1394) Randomisation was undertaken by a person unconnected with the study in a different location, who used a computer randomisation programme. Researchers gave them the blocking variables and the allocation was emailed back (correspondence with author)
Allocation concealment (selection bias)	Low risk	"Randomisation and capsule packing performed externally" (P.1394)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants, clinicians and researchers were blind to allocation. Identical placebo and capsules odourless, however when checked the majority ("90% fish oil group, 64% placebo group) of participants correctly guessed their assignment" (P.1395)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	HDRS ‐ clinician‐rated: physicians blinded to allocation (LOW) BDI ‐ self report (HIGH)
Blinding of outcome assessment (Adverse Events)	High risk	AEs ‐ participant‐rated
Incomplete outcome data (attrition bias) All outcomes	High risk	ITT analysis conducted but 28% dropped out
Incomplete outcome data (Adverse Events)	High risk	AEs not clearly reported, plus > 10% drop out.
Selective reporting (reporting bias)	Low risk	All relevant outcomes reported (correspondence with author)
Other bias	Low risk	Study appeared to be free from other sources of bias