Cutler 1993.
Methods | 1. Randomized 2. Double blind 3. Three parallel groups ‐ placebo ‐ Ipsapirone 10‐30 mg/d ‐ Lorazepam 2‐6 mg/d 4. Duration: 4 weeks ‐ acute treatment 4 weeks ‐ extended treatment 2 weeks ‐ withdrawal period with a 1‐week placebo lead‐in prior 5. Analysis: LOCF |
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Participants | 1. Diagnosis: GAD (DSM‐III) 2. N = 90 3. Age (mean): placebo = 32.9 Lorazepam = 29.1 Ipsapirone = 31.2 Sex: 62.2% females Setting: outpatients History: excluded any significant psychiatric disorder other than GAD |
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Interventions | 1. Placebo (N = 30) 2. Lorazepam (N = 30) 3. Ipsapirone (N = 30) |
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Outcomes | 1. dropout rates 2. CGI scores 3. HAM ‐A 4. Physisicans Withdrawal Checklist 5. Zung Anxiety Scale 6. HAM‐D |
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Notes | (a) CGI and HAM‐A not entered into final analysis as means and SDs not reported; (b) only HAM‐A for Ipsapirone vs benzodiazepine entered secondary to means and SDs reported‐week 8 used |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |