Lecrubier 1997.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III‐R panic disorder with or without agoraphobia Method of diagnosis: not stated Age: for paroxetine, M = 34.7 (SD = 9.3); for clomipramine, M = 35.1 (SD = 9.2) Sex: for paroxetine, 53 males, 70 females; for clomipramine 46 males, 75 females Location: 39 centres in Belgium, Denmark, France, Hungary, Ireland, Israel, Italy, the Netherlands, Norway, Spain, Switzerland, UK, Yugoslavia; setting: outpatients Co‐morbidities: none Rescue medication: chloral hydrate for night time sedation allowed |
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Interventions |
Participants were randomly assigned to either: (1) paroxetine arm (n = 123) Duration: 12 weeks Treatment Protocol: flexible dosage, range = 10 ‐ 60 mg, M and SD not provided (2) clomipramine arm (n = 122) Duration: 12 weeks Treatment Protocol: flexible dosage, range = 10 ‐ 150 mg, M and SD not provided (3) placebo arm (n = 123) Duration: 12 weeks |
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Outcomes |
Time points for assessment: weeks 3, 6, 9, 12 Outcomes: 1. change in number of panic attacks 2. proportion of subjects with zero panic attacks 3. proportion of subjects with a > 50% reduction in the number of panic attacks 4. change in intensity of panic attacks 5. Hamilton Rating Scale for Anxiety (HAMA) 6. Clinical Global Impression Scale (CGI) 7. Montgomery–Åsberg Depression Rating Scale (MADRS) 8. Mark Sheehan Phobia Scale 9. Patient Global Evaluation (PGE) 10. Sheehan Disability Scale |
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Notes |
Date of study: October 1991 ‐ November 1993 Funding source: Sponsored by GSK Declarations of interest among the primary researchers: Department of Clinical Research, Development and Medical Affairs, SmithKline Beecham Pharmaceuticals |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blind". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blind". No further details. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "the primary and secondary efficacy analysis were performed on the ITT population, which included all subjects who were randomized, who received their randomized treatment and for whom at least one assessment was available after active treatment. Safety assessment were performed on the ITT population. Dropouts rates were around 30% in both treatment arms. |
Selective reporting (reporting bias) | Unclear risk | All outcomes were reported. |
Other bias | High risk | Sponsored by GSK; the role of the funder in planning, conducting and writing the study is not discussed. |