Nair 1996.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III‐R panic disorder with or without agoraphobia Method of diagnosis: not stated Age: for fluvoxamine, M = 34.5; for imipramine, M = 34.5, SD not provided Sex: for fluvoxamine 56% females 44% males; for imipramine 50% females 50% males Location: Canada; setting: outpatients Co‐morbidities: patients with a history of bipolar disorder, organic brain syndrome, schizophrenia or other psychotic disorders were excluded Rescue medication: oxazepam up to 60 mg daily or chloral hydrate up to 2000 mg daily were permitted during first four weeks of treatment |
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Interventions |
Participants were randomly assigned to either: (1) fluvoxamine arm (n = 50) Duration: 8 weeks Treatment Protocol: flexible dosage, range = 50 ‐ 300 mg, M = 171.4, SD not provided (2) imipramine arm (n = 48) Duration: 8 weeks Treatment Protocol: flexible dosage, range = 50 ‐ 300 mg, M = 164.7, SD not provided (3) placebo arm (n = 50) Duration: 8 weeks |
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Outcomes |
Time points for assessment: weekly Outcomes: 1. Sheehan Panic and Anticipatory Anxiety Scale 2. Clinical Global Impression Scale (CGI) 3. Montgomery–Åsberg Depression Rating Scale (MADRS) 4. Sheehan Disability Scale (SDS) 5. Sheehan Panic Attack Diary (intensity and number of panic attacks) 6. Sheehan Phobia Scale 7. Hopkins Symptom Checklist |
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Notes |
Date of study: Not stated Funding source: Orto McNeil Ltd. 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: "randomized". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the study medication was in the form of identically appearing capsules each containing either placebo, 50 mg of fluvoxamine or 50 mg of imipramine". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the study medication was in the form of identically appearing capsules each containing either placebo, 50 mg of fluvoxamine or 50 mg of imipramine". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "two patient samples were identified for analysis and reporting purposes prior to unblinding: an all patients analysis and an ITT. The all patients sample was defined as those randomised to double blind treatment and who provided at least some drug safety and tolerance data [...] the main efficacy analysis of the study was based on the LOCF of the ITT sample". |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | Sponsored by Orto McNeil Ltd; the role of the funder in planning, conducting and writing the study is not discussed. |