Wade 1997.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III‐R panic disorder Method of diagnosis: not stated Age: M = 38, SD not provided Sex: 70% female, 30 % male Location: not stated; setting unclear Co‐morbidities: patients with depression, organic brain damage, drug/alcohol misuse and other severe psychiatric or somatic disorders were excluded Rescue medication: treatment with oxazepam was permitted during weeks 1 and 2 (maximum dose 20 mg daily), discontinued during weeks 3 and 4, and prohibited during weeks 5 to 8. |
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Interventions |
Participants were randomly assigned to either: (1) citalopram 10‐15 mg arm (n = 97) Duration: 8 weeks Treatment Protocol: 10 mg, with the option of increasing to 15 mg if efficacy was not seen (2) citalopram 20‐30 mg arm (n = 95) Duration: 8 weeks Treatment Protocol: 20 mg, with the option of increasing to 30 mg if efficacy was not seen (3) citalopram 40‐60 arm (n = 89) Duration: 8 weeks Treatment Protocol: 40 mg, with the option of increasing to 60 mg if efficacy was not seen (4) clomipramine (n = 98) Duration: 8 weeks Treatment Protocol: 60 mg, with the option of increasing to 90 mg if efficacy was not seen (5) placebo (n = 96) |
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Outcomes |
Time points for assessment: baseline, last assessment (no further details provided) Outcomes: 1. number of panic attacks ‐ Clinical Anxiety Scale (CAS) 2. general improvement (Physician's Global Improvement Scale, Patient's Global Improvement Scale) 3. Hamilton Anxiety Rating Scale (HAS) 4. Montgomery–Åsberg Depression Rating Scale (MADRS) |
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Notes |
Date of study: not stated Funding source: not stated Declarations of interest among the primary researchers: None (but authors' affiliations refer to pharmaceutical companies). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomised". |
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 information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind". No further information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "the primary analysis of efficacy was based upon the relative number of responding patients for the ITT population and by use of the LOCF". |
Selective reporting (reporting bias) | Unclear risk | All outcomes were reported; data on CAS are reported only in graphs. |
Other bias | Unclear risk | One of the authors' affiliation refer to Lundbeck. |