Bakish 1993.
| Methods | Study design: Randomised controlled trial | |
| Participants |
Diagnosis: DSM‐III panic disorder with or without agoraphobia Method of diagnosis: Not stated Age: No information provided Sex: No information provided Location: Canada; setting: outpatients Co‐morbidities: Not stated Rescue medication: Chloral hydrate, up to 1 g at night |
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| Interventions | Participants were randomly assigned to either: (1) brofaromine arm (n = 47) Duration: 8 weeks Treatment Protocol: flexible dosage; range = 50 ‐ 150 mg, M and SD not provided (2) clomipramine arm (n = 46) Duration: 8 weeks Treatment Protocol: flexible dosage; range = 25 ‐ 75 mg, M and SD not provided |
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| Outcomes |
Time points for assessment: baseline, every two weeks Outcomes: 1. number of panic attacks per week 2. Hamilton Rating Scale for Anxiety (HAMA) 3. Hamilton Rating Scales for Depression (HAM‐D) 4. Clinician Rated Impairment and Disability Scale (CRIDS) 5. Clinician Rated Global Change Scale (CRGCS) 6. Patient Rating Impairment Disability Scale (PRIDS) 7. Patient Rated Anxiety Scale (PRAS) 8. Marks Matthews Phobia Scale 9. Patient Rated Global Change Scale (PRGCS) 10. Daily Panic Inventory (DPI) |
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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: "randomised". No further details. |
| 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 | Unclear risk | No clear information on incomplete outcome data management. |
| Selective reporting (reporting bias) | High risk | Data on the scales HAMD, CRIDS, CRGCS, PRIDS, PRAS, PRCGS, DPI not reported at endpoint; data on the scales HAMA and Mark Matthews Phobia Scale are reported only in graphs; number of patients evaluated not specified. |
| Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |