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. 2016 Sep 12;2016(9):CD011567. doi: 10.1002/14651858.CD011567.pub2

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.