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. 2016 Sep 12;2016(9):CD011567. doi: 10.1002/14651858.CD011567.pub2

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
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
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
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
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.