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

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
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)
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)
Notes Date of study: Not stated
Funding source: Not stated
Declarations of interest among the primary researchers: Not stated
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.