Methods | ALLOCATION CONCEALMENT: unclear BLINDING: at least one measure was assessed by an independent assessor blind to treatment allocation | |
Participants | DIAGNOSIS: DSM‐III‐R panic disorder with or without agoraphobia (42% with moderate or severe agoraphobia) AGE: mean=33.6 to 37.8 years SEX: 65% women HISTORY: mean duration of panic disorder=4.6 years PSYCHIATRIC COMORBIDITY: Major depression was included if it preceded panic. Those with history of seizures, bipolar or melancholic depression, cyclothymic disorder, obsessive‐compulsive disorder or current drug or alcohol dependence were excluded. MEDICAL COMORBIDITY: "In good physical health." | |
Interventions | ACUTE PHASE: 6 weeks 1. clomipramine (100 mg/d) or lofepramine (140 mg/d) + CBT (6 one‐hour sessions over eight weeks) 2. placebo + CBT ACUTE PHASE CO‐INTERVENTION: No psychotropic drug was allowed. MAINTENANCE: None. MODE OF DISCONTINUATION: ‐ FOLLOW‐UP: None (After 6 weeks, those on placebo received antidepressants and the double‐blind was broken at 8 weeks) |
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Outcomes | RESPONSE: >=40% reduction in CGI [imputed from mean&SD] REMISSION: panic‐free GLOBAL: CGI Severity, CGI Change PANIC ATTACK: ‐ AGORAPHOBIA: Fear Inventory GENERAL ANXIETY: HAM‐A DEPRESSION: HAM‐D, MADRS, CGI Depression, BDI, Wakefield Self Assessment Depressiion Inventory FUNCTIONING: ‐ | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |