Roth 1996.

Methods	Randomised, placebo‐controlled, parallel group study design of 6‐week duration
Participants	Country: international multicentre (41 centres) Setting: in‐ and outpatients Number: 694 (532 females, 162 males) Age: 60 to 90 years, mean: 73.6 (8.4) Inclusion criteria: DSM‐III for dementia and with depression, or DSM‐III for major depressive episode with cognitive decline; 11< MMSE < 28; 18‐item SCAG >= 40; Geriatric Depression Scale >= 5; 17‐item Hamilton >= 14. Exclusion criteria: severe uncontrolled systemic disease, other neurological or major psychiatric disorder, psychotropic drugs
Interventions	1. Moclobemide 400 mg/day 2. Placebo
Outcomes	HAM‐D MMSE SCAG CGAE BGP
Notes	No specific information on subgroup of patients with DSM depression and DSM dementia (n = 476) No usable statistics for efficacy analyses; after a discussion by the review team, only the adverse events data were used. Source of funding not specifically mentioned but likely to have been Hoffmann‐La Roche Ltd., Basel, Switzerland, manufacturers of moclobemide, as one author was an employee of the company.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"random assignment within centre" ‐ No further information on randomisation is provided.
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding (performance bias and detection bias) All outcomes	Unclear risk	"Treatment was with either a fixed dose of moclobemide 400 mg or a matched placebo [...]. a placebo run‐in period of 14 days was envisaged but not rigidly enforced. Patients with signs of rapid deterioration during the run‐in period were entered into the double‐blind treatment phase, after a minimum wash‐out of four days."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Out of 726 recruited patients, 14 had unclassifiable diagnoses and 18 missing efficacy data (but were still included in the "safety population").
Selective reporting (reporting bias)	High risk	The depression rating scale scores were reported incompletely, therefore, only the adverse event and tolerability data from this study were used for the purposes of this review. "The safety data are based on the total group of randomised patients. All those who completed 10 days of treatment or gave as a reason for withdrawal, lack of efficacy, poor tolerability or adverse effects, were included in the analysis of efficacy as the 'intent to treat group' (ITT). The few patients who dropped out for any other reason were excluded from the efficacy analysis but were included in the safety analysis (N = 726).
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	"Treatment was with either a fixed dose of moclobemide 400 mg or a matched placebo [...]. a placebo run‐in period of 14 days was envisaged but not rigidly enforced. Patients with signs of rapid deterioration during the run‐in period were entered into the double‐blind treatment phase, after a minimum wash‐out of four days."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No description of how blinding of outcome assessors was checked was provided.