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. 2021 Sep 12;2021(9):CD011612. doi: 10.1002/14651858.CD011612.pub3

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)
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
Outcomes HRSD
Response rate (≥ 50% reduction in HRSD scores)
Remission rate (HRSD score ≤ 7)
HAMA
CGI
BDI
Adverse events
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