Diazgranados 2010.
| Study characteristics | ||
| Methods | Randomised, double‐blind placebo‐controlled trial (cross‐over) | |
| Participants |
Diagnosis: DSM‐IV bipolar I or II depression without psychotic features; MADRS score ≥ 20; current major depressed episode for at least 4 weeks.
N: 18 randomised. Age: 47.9 years (SD = 13.1) Sex: 12 females, 6 males. Baseline depression severity: phase 1: Placebo group MADRS = 33.889 (SD = 4.833); ketamine group MADRS = 31.222 (SD = 4.410) |
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| Interventions | Ketamine (9 in phase 1) vs placebo (9 in phase 1) as add‐on treatment to valproate or lithium, as mood stabilisers (continued taking as usual, but no other treatment allowed) 2 weeks (study duration) ketamine = 0.5 mg/kg single intravenous dose Intravenous saline solution as placebo 2‐week washout period |
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| Outcomes | Change in MADRS scale HRSD‐17 score BDI Visual Analogue Scale Hamilton Anxiety Rating Scale BPRS Clinician Administered Dissociative Scale YMRS Response rate (50% improvement from BL in MADRS) Remission rate (MADRS score < 10) Dropout rate Adverse events |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: Patients were randomly assigned to the order in which they received the two infusions by a random number chart" |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | All staff, including the anaesthesiologist, were blind to whether placebo or drug was being administered. Study solutions were supplied in identical 50 mL syringes |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rates reported and 'n' given for each time point |
| Selective reporting (reporting bias) | Unclear risk | No results tables available in original publication. All requested data received through correspondence |
| Other bias | Unclear risk | No other bias was identified in this study, but this possibility cannot be ruled out |