Pfizer 2008.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: Panic disorder with or without agoraphobia according to DSM IV Method of diagnosis: no information provided Age: range = 18 ‐ 64 years, mean and SD not provided Sex: sertraline: female = 113, male = 44; paroxetine: female = 109, male = 53 Location: Japan; setting unclear Co‐morbidities: "patients with bipolar disorder, schizophrenia, delusional disorder, epilepsy, MDD, OCD, seasonal affective disorder or GAD were excluded; patients who concurrently have depression/depressive state, anxiety disorder and generalized anxiety disorder may be included if the primary diagnosis is identified to be panic disorder" Rescue medication: none |
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Interventions |
Participants were randomly assigned to either: (1) sertraline arm (n = 157) Duration: 12 weeks Treatment Protocol: flexible dosage, range = 25 ‐ 100 mg (2) paroxetine arm (n = 164) Duration: 12 weeks Treatment Protocol: flexible dosage, range = 10 ‐ 30 mg |
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Outcomes |
Time points for assessment: Outcomes: 1. Panic and Agoraphobia Scale 2. Clinical Global Impression Improvement Score (CGI‐I) 3. frequency of panic attacks 4. Hamilton Rating Scale for Anxiety (HAMA) |
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Notes |
Date of study: May 2008 ‐ February 2010 Funding source: Pfizer 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: "Allocation: randomized" |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Masking: double‐blind (subject, investigator)" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Masking: double‐blind (subject, investigator)" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Last Obsevation Carried Forward" |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | Sponsored by Pfizer; the role of the funder in planning, conducting and writing the study is not discussed. |