Rezvanian 2010.

Methods	Parallel randomised controlled trial, randomisation ratio: 1:1:1:1, superiority design
Participants	Inclusion criteria: aged 10 to 18 years failure in weight loss after 3 months of nonpharmacological treatment (by lifestyle modification advised in study author's clinic) BMI ≥ age‐ and sex‐specific 95th percentile according to the revised CDC growth charts Exclusion criteria: people with syndromal obesity, endocrine disorders, any physical disability, history of chronic medication use, using monoamine oxidase inhibitors, history of mood disorder in parents and first‐degree relatives (depression or bipolar), history of any chronic diseases (e.g. kidney disorders, lung diseases, hepatitis or a combination) Diagnostic criteria: see above
Interventions	Intervention 1: metformin + healthy eating + physical activity advice Intervention 2: fluoxetine + healthy eating + physical activity advice Intervention 3: metformin + fluoxetine + healthy eating + physical activity advice Comparator: placebo + healthy eating + physical activity advice Number of trial centres: 1 Treatment before trial: 3 months of nonpharmacological treatment (by lifestyle modification advised in study author's clinic) Titration period: metformin dosage increased weekly from 500 mg/day to 1500 mg/day. Fluoxetine dosage of 10 mg/day increased to 20 mg/day after 3 weeks
Outcomes	Outcomes reported in abstract of publication: BMI, waist circumference, adverse effects
Study details	Run‐in period: no Trial terminated early: no
Publication details	Language of publication: English Noncommercial funding Publication status: peer‐reviewed journal
Stated aim for study	Quote from publication: "We aimed to compare the effects of three types of drug regimens and placebo on generalized and abdominal obesity among obese children and adolescents who did not succeed to lose weight 3 months after lifestyle modification (diet and exercise)"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Sequence was generated by computer generated random number table" Comment: randomisation was an adequate method
Allocation concealment (selection bias)	Unclear risk	Comment: unclear if allocation was concealed
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Quote: "triple‐masked randomized clinical trial" Comment: participants and personnel would have been blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Quote: "triple‐masked randomized clinical trial" Comment: participants and personnel would have been blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: "triple‐masked randomized clinical trial" Comment: outcomes assessors would have been blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote: "triple‐masked randomized clinical trial" Comment: outcomes assessors would have been blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: an imputation method was not used to replace missing data; however, dropout rate was fairly low
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: an imputation method was not used to replace missing data; however, dropout rate was fairly low
Selective reporting (reporting bias)	Unclear risk	Comment: unable to assess if all outcomes were reported due to the unavailability of a protocol
Other bias	Unclear risk	Comment: unable to access if any other bias was present