Ribeiro 2001.
| Methods | Study design: Randomised controlled trial | |
| Participants |
Diagnosis: DSM‐IV panic disorder with or without agoraphobia Method of diagnosis: not stated Age: for mirtazapine, M = 36.1, SD = 10.9; for fluoxetine, M = 36.4, SD = 10.1 Sex: for mirtazapine, 86.7% females, for fluoxetine 66.7% females Location: Brasil; setting: outpatients Co‐morbidities: patients with psychiatric and physical disorders were excluded Rescue medication: none |
|
| Interventions |
Participants were randomly assigned to either: (1) mirtazapine arm (n = 15) Duration: 8 weeks Treatment Protocol: flexible dosage, range = 15 ‐ 30 mg, M = 17.9, SD = 4.3 (2) fluoxetine arm (n = 15) Duration: 8 weeks Treatment Protocol: flexible dosage, range = 10 ‐ 20 mg, M = 13.1, SD = 3.2 |
|
| Outcomes |
Time points for assessment: Baseline, week 1, 2, 4, 6 and 8 Outcomes: 1. Panic Diary 2. Clinical Global Impression Severity of Illness Score (CGI‐S) 3. Clinical Global Impression Improvement Score (CGI‐I) 4. Hamilton Rating Scale for Anxiety (HAMA) 5. Sheehan Phobic Scale |
|
| Notes |
Date of study: November 1998 ‐ March 1999 Funding source: research supported by FIPE‐HCPA (FUNDO DE INCENTIVO À PESQUISA E EVENTOS) Declarations of interest among the primary researchers: Not stated. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "patients were randomised to mirtazapine or fluoxetine using a computer program which assigned 15 patients to each group". |
| Allocation concealment (selection bias) | Low risk | Quote: "a person who was not participating in the study labeled flasks containing enough medications for periods between visits". |
| 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 | Quote: "the analysis included all patients who took at least one dose of medication during the double‐blind phase and who provided any follow‐up data". |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
| Other bias | Unclear risk | Organon Pharmaceutical kindly provided mirtazapine for the trial. |