Noyes 1996.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III panic disorder or agoraphobia with panic attacks Method of diagnosis: Structured Clinical Interview for DSM‐III, Upjohn Version Age: M = 36.6; SD = 10.5 Sex: women = 157, men = 84 Location: USA, Australia; setting: outpatients Co‐morbidities: patients with major psychiatric co‐morbidities, head trauma or seizures were excluded Rescue medication: none |
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Interventions |
Participants were randomly assigned to either: (1) diazepam arm (n = 81) Duration: 8 weeks Treatment Protocol: flexible dosage, range = 10 ‐ 100 mg, M = 43, SD not provided (2) alprazolam arm (n = 78) Duration: 8 weeks Treatment Protocol: flexible dosage, range = 1 ‐ 10 mg, M = 4.9, SD not provided (3) placebo arm (n = 79) Duration: 8 weeks |
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Outcomes |
Time points for assessment: baseline, 4 weeks, 8 weeks Outcomes: 1. frequency of panic attacks 2. Sheehan Self Rated Scale for Anxiety 3. Hamilton Rating Scale for Anxiety (HAMA) 4. Marks and Mathews Agoraphobia Scale 5. Profile of Mood States 6. Hamilton Rating Scale for Depression (HRSD) 7. Work and Social Disability Scale 8. Systematic Assessment for Treatment‐Emergent Events |
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Notes |
Date of study: not stated Funding source: supported by a grant from the Upjohn Company 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: "to examine differences in treatment groups over time we completed ITT analysis using logistic regression procedures. The results of analysis using the completer sample were very similar to those using the III subjects". |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | Supported by a grant from the Upjohn Company; the role of the funder in planning, conducting and writing the study is not discussed. |