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. 2023 Nov 28;2023(11):CD012729. doi: 10.1002/14651858.CD012729.pub3

Lecrubier 1997.

Study characteristics
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, mean = 34.7 (SD 9.3); for clomipramine, mean = 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 mg to 60 mg, mean and SD not provided
2. Clomipramine arm (n = 122)
Duration: 12 weeks
Treatment protocol: flexible dosage, range = 10 mg to 150 mg, mean 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 participants with zero panic attacks

  3. Proportion of participants 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 to 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". No further information provided.
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 Low 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) Low 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.