GSK‐29060/1.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: Panic disorder according to the DSM ‐ III criteria Method of diagnosis: Structured Clinical Interview (SCID) for DSM ‐ III Age: for paroxetine, M = 39.1 (SD = 11.1); for alprazolam, M = 39.5 (SD = 12.5) Sex: for paroxetine, 49 women, 28 men; for alprazolam 48 women, 28 men Location: USA; setting: outpatients Co‐morbidities: patients with Axis I disorders other than panic disorder, current major depression (unless panic disorder dominated the clinical picture and preceded affective symptoms chronologically), any severe or uncontrolled medical condition were excluded Rescue medication: Not stated |
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Interventions |
Participants were randomly assigned to either: (1) paroxetine arm (n = 77) Duration: 10 weeks Treatment Protocol: flexible dosage; range = 10 ‐ 60 mg, M and SD not provided (2) alprazolam arm (n = 77) Duration: 10 weeks Treatment Protocol: flexible dosage; range = 1 ‐ 6 mg, M and SD not provided (3) placebo arm (n = 72) Duration: 10 weeks |
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Outcomes |
Time points for assessment: baseline, endpoint (10 weeks) Outcomes: 1. % of patients having zero panic attacks 2. mean change from baseline in the number of panic attacks 3. % of participants with a > 50% reduction from baseline in the number of full panic attacks 4. Clinical Global Impression Severity of Illness Score (CGI‐S) 5. number of full and limited panic attacks 6. intensity of panic attacks 7. anticipatory anxiety 8. Marks Sheehan Phobia Scale 9. Clinical Global Impression Improvement Score (CGI‐I) 10. Hamilton Rating Scale for Anxiety (HAMA) 11. Montgomery–Åsberg Depression Rating Scale (MADRS) 12. Sheehan Disability Scale (SDS) 13. Social Adjustment Self‐Report Questionnaire |
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Notes |
Date of study: November 1992 to April 1994 Funding source: GSK Declarations of interest among the primary researchers: Not stated. |
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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 | Low risk | Quote: "All subjects in the ITT population (which included all subjects who received any double blind medication) for whom at least one valid post efficacy evaluation was available were included in the ITT efficacy analysis. All subjects randomized were included in the safety analysis". |
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. |