Krueger 1999.
| Methods | Study design: Randomised controlled trial | |
| Participants |
Diagnosis: DSM ‐ III ‐ R panic disorder with or without agoraphobia Method of diagnosis: SCID Axis I, Roche edition Age: for moclobemide, M = 35.0 (SD = 8.9); for clomipramine, M = 36.0 (SD = 9.5) Sex: for moclobemide, 41.8% males, 58.2 females; for clomipramine 39.7% males, 60.3% females Location: Norway, Sweden, the Netherlands; setting unclear Co‐morbidities: none, except of generalised anxiety disorders and social phobia of less than moderate severity Rescue medication: chloral hydrate as an occasional night time hypnotic |
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| Interventions |
Participants were randomly assigned to either: (1) moclobemide arm (n = 67) Duration: 8 weeks Treatment Protocol: fixed‐flexible dosage, range = 300 ‐ 600 mg, M and SD not provided (2) clomipramine arm (n = 68) Duration: 8 weeks Treatment Protocol: fixed‐flexible dosage, range = 100 ‐ 200 mg, M and SD not provided |
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| Outcomes |
Time points for assessment: week 1, 2, 4, and 8 Outcomes: 1. number of panic attacks 2. Patients' Clinical Global Impression of Change (P‐CGI‐C) 3. Investigators' rating of Clinical Global Impression of the Severity of the patients' panic disorder (I‐CGI‐S) 4. Patients' rating of Clinical Global Impression of Severity (P‐CGI‐S) 6. Sheehan Disability Scale (SDS) 7. Hamilton Rating Scale for Anxiety (HAMA) 8. Montgomery–Åsberg Depression Rating Scale (MADRS) |
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| Notes |
Date of study: Not stated Funding source: Hoffmann ‐ La Roche 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: "it was estimated that the ITT population with two‐sided significance level of 0.05 and a power of at least 0.8 had to be at least 66 patients in each treatment group"; "the ITT population comprised 135 patients who had received treatment and at least one assessment after baseline". |
| Selective reporting (reporting bias) | Unclear risk | All outcomes were reported. |
| Other bias | High risk | Sponsored by Hoffmann‐La Roche; the role of the funder in planning, conducting and writing the study is not discussed. |