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

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
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
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
Notes Date of study: Not stated
Funding source: Orto McNeil Ltd.
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: "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.