Holland 1999.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM ‐ III ‐ R panic disorder with or without agoraphobia Method of diagnosis: Not stated Age: for adinazolam, M = 36.5; for clomipramine, M = 35.8; SD not provided Sex: for adinazolam, 36% male; for clomipramine 38% male Location: UK; setting unclear Co‐morbidities: patients with psychiatric co‐morbidities were excluded Rescue medication: Not stated |
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Interventions |
Participants were randomly assigned to either: (1) adinazolam arm (n = 166) Duration: 24 weeks Treatment Protocol: flexible dosage; range = 30 ‐ 90 mg, M and SD not provided (2) clomipramine arm (n = 149) Duration: 24 weeks Treatment Protocol: flexible dosage; range = 50 ‐ 150 mg, M and SD not provided |
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Outcomes |
Time points for assessment: weeks 1, 2, 4, 8, 12, 16, 20 and 24 Outcomes: 1. total number of panic attacks (Panic Attack and Anticipatory Anxiety scale) 2. Clinical Global Impression Improvement Score (CGI‐I) 3. SCL ‐ 90, Phobic Anxiety Dimension 4. Sheehan Disability Scale |
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Notes |
Date of study: Not stated Funding source: Not stated 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 | High risk | LOCF data are reported, but without specifying number of patients evaluated. |
Selective reporting (reporting bias) | Unclear risk | All outcomes were reported, but without specifying number of patients evaluated. |
Other bias | Unclear risk | Authors' affiliations refer to pharmaceutical companies. |