Park 2017.
Study characteristics | ||
Methods | Double‐blind placebo‐controlled pilot study | |
Participants |
Diagnosis: DSM‐IV Bipolar disorder, MADRS score ≥20 N: riluzole N=8, placebo N=11 Age: Riluzole group: 45.25 (SD = 15.46) Placebo group: 47.64 (SD = 11.11) Sex: riluzole group: 7 males, 1 female Placebo group: 6 males, 5 females Baseline depression severity: data unavailable |
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Interventions | Participants were tapered off of any medications and were free of medications with central nervous system effects for seven days prior to the study and throughout the study, except for lorazepam as needed (up to 2 mg/day to manage agitation or anxiety). Riluzole (50 mg to 200mg/day) or placebo for eight weeks administered orally. Riluzole dosing began at 50 mg, twice daily, and was increased on a weekly basis by 50 mg, as tolerated, up to a maximum dose of 200 mg/day. |
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Outcomes | Dropout rate | |
Notes | Trial ended prematurely due to futility. Limited data available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote:"Randomized in a 1:1 allocation" |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details given. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details given. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Not significant. |
Selective reporting (reporting bias) | High risk | Data from many outcomes not published. |
Other bias | Unclear risk | None detected. |