Michelson 2007.
Study characteristics | ||
Methods | Double‐blind randomised controlled trial | |
Participants |
Diagnosis: DSM‐IV major depressive disorder; HRSD‐17 score ≥ 18
N: 146 Age: atomoxetine group = 44.0 (SD = 12.3); placebo group = 45.5 (SD = 13.8) Sex: aAtomoxetine group 65% female; placebo group 66% female Baseline depression severity: atomoxetine group HRSD = 23.4 (SD = 3.5); placebo group MADRS = 23.1 (SD = 4.3) |
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Interventions | All patients first received 8 weeks of treatment with sertraline, initiated at 100 mg/day and increased in 50 mg increments to a maximum of 200 mg/day, based on efficacy and tolerability. Patients with a score > 4 on the Maier and Phillip core mood severity scale (MPS) of the HRSD were randomly assigned to 8 weeks of sertaline combined with atomoxetine or placebo Atomoxetine (N = 72) initiated at 40 mg/day, could be increased in 40 mg increments to a maximum of 120 mg/day, based on efficacy and tolerability Placebo (N = 74) The dose of sertraline during randomised treatment was fixed at 150 mg/day or 100 mg/day for patients who were unable to tolerate 150 mg/day during initial sertraline treatment Concomitant treatment: Unclear |
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Outcomes | Maier and Phillip core mood severity scale (MPS) of the HRSD HRSD CGI‐S Remission rate (MPS score ≤ 4 and no single item >1) Non response rate (< 30% reduction in MPS) Partial response rate (> 30% reduction in MPS but MPS > 4) Adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | No details given on random sequence generation, other than quote: ''were randomly assigned" |
Allocation concealment (selection bias) | Unclear risk | No details given on random sequence generation, other than quote ''were randomly assigned under double‐blind conditions'' |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | To minimise rating bias, investigators and patients were blind to the symptom severity threshold for randomisation. To preserve this blinding, patients who met the response criteria (MPS ≤ 4 and no single item > 1) after the initial 8 weeks continued sertraline monotherapy in the randomised phase but were not included in the analyses of results from the randomised phase of the trial |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details given on blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Responders data are per individual and only out of 26 and 28 rather than 72 and 74. Seems unclear |
Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
Other bias | Low risk | No other potential sources of bias identified |