Heresco‐Levy 2006.
Study characteristics | ||
Methods | Double‐blind randomised controlled cross‐over trial | |
Participants |
Diagnosis: DSM‐IV major depressive disorder; ≥ 4 weeks of treatment with an antidepressant drug; score ≥ 18 on HRSD‐21
N: 22 Age: M = 56.9 (SD = 12.4) Sex: 45% female Baseline depression severity: HRSD = 27.2 (SD = 5.2) |
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Interventions | 6 weeks of treatment D‐cycloserine (N = 9) 250 mg orally per day Placebo (N= 13) in identical capsules to D‐cycloserine Concomitant treatment: y es, patients continued on existing psychotropic medications |
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Outcomes | HRSD HAMA Zung Self Rating Depression Scale PANSS UKU Side Effects Rating Scale | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: ''subjects were randomly allocated, without blocking, stratification or other restrictions'' no further details given |
Allocation concealment (selection bias) | Unclear risk | No details given on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: ''Clinical and research staff, patients and their families were unaware of and could not determine the study drug assignment by appearance or otherwise'' |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: ''double blind'' no further details given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study reports dropouts |
Selective reporting (reporting bias) | Unclear risk | Protocol not available, unclear if all prespecified outcomes reported in published report |
Other bias | Low risk | No other potential sources of bias identified |