Heresco‐Levy 2013.
Study characteristics | ||
Methods | Double‐blind randomised controlled trial | |
Participants |
Diagnosis: DSM‐IV major depressive disorder; insufficient therapeutic response during the current episode, defined as a ≥ 20 score on the HRSD‐21 despite two or more adequate antidepressant medication trials
N: 26 Age: M = 53.0 (SD = 10.2) Sex: 62% female Baseline depression severity: D‐cycloserine group HRSD = 25.1 (SD = 5.6); placebo group HRSD = 27.2 (SD = 4.9) |
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Interventions | 6 weeks of treatment D‐cycloserine (N = 13) gradually titrated: 250 mg (one capsule)/d for 3 days ‐> 500 mg (two capsules)/d for 18 days ‐> 750 mg (three capsules)/day for 1 week ‐> and 1000 mg (four capsules)/d for the last 2 weeks Placebo (N = 13) in identical capsules to D‐cycloserine and according to same dose escalation schedule Concomitant treatment: yes, patients continued on existing psychotropic medications |
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Outcomes | HRSD
Response rate (≥ 50% reduction in HRSD scores) Remission rate (HRSD score ≤ 7) HAMA CGI BDI Adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: ''randomly allocated using a block size of four'' |
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 unavailable, but data reported matches methods |
Other bias | Low risk | No other potential sources of bias identified |