Amore 1999.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐IV Panic Disorder with or without agoraphobia Method of diagnosis: Not stated Age: for fluoxetine, M = 37.0 (SD = 7.1); for imipramine, M = 37.2 (SD = 8.2) Sex: for fluoxetine, 57.89% women, 42.11% men; for imipramine 36.84% women, 63.16% men Location: Italy; setting unclear. Co‐morbidities: patients with history of psychosis, current major depression, organic brain syndromes or significant neurological disorders, seizures, clinically relevant cardiovascular, hepatic, renal or haematological diseases were excluded Rescue medication: Oxazepam (up to a maximum daily dose of 30 mg) permitted during first four weeks of double‐blind treatment |
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Interventions | Participants were randomly assigned to either: (1) fluoxetine arm (n = 19) Duration: 24 weeks of active treatment (acute and continuation phase), 6 months maintenance phase for responders Treatment Protocol: flexible dosage; range = 10 ‐ 50 mg, M = 20 mg/day (SD = 10) (responder group) (2) imipramine arm (n = 19) Duration: 24 weeks of active treatment (acute and continuation phase), 6 months maintenance phase for responders Treatment Protocol: flexible dosage; range = 25 ‐ 250 mg, M = 150 mg/day (SD = 25) (responder group) |
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Outcomes |
Time points for assessment: baseline and weekly for 16 weeks, every two weeks between week 17 and 24, later monthly Outcomes: 1. Panic‐Associated Symptoms Scale (PASS) 2. Hamilton Rating Scale for Anxiety (HAMA) 3. Hamilton Rating Scale for Depression (HRSD) 4. Clinical Global Impression (CGI) |
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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: "they were randomly assigned to fluoxetine or imipramine treatment". 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 CGI, PASS and HRSD not reported at endpoint. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |