| Methods |
Twenty‐week randomised, double‐blind study |
| Participants |
Outpatients fulfilling DSM‐III‐R criteria for major depressive disorder, without melancholia, with a score of at least 21 on the Hamilton Rating Scale for Depression (HDRS‐24) and a score of at least 2 on the item 1 of HDRS‐21 and a score of maximum 18 on the Hamilton Rating Scale for Anxiety (HAM‐A), a score of at least 8 on the Raskin Depression Scale (RDS) and a total Covi Anxiety Scale (CAS) less than RDS.
Age range: 18‐65 years
Exclusion criteria: any clinically significant hematological, endocrine, cardiological, renal, gastrointestinal, neurological disorder, seizure disorder, significant suicidal risk, other Axis I disorders besides dysthymia, Axis 2 diagnosis of antisocial or borderline disorder, history of substance or alcohol abuse within 6 months, ECT in the previous 6 months, use of MAOI or fluoxetine within 3 weeks, any other antidepressant within the last week, use of benzopines within the last 2 weeks, being in any type of psychotherapy since less than 3 months, or having ended such therapy within 1 month prior the study. |
| Interventions |
Fluoxetine: 72 participants
ABT‐200: 72 participants
Fluoxetine dose: 20 mg/day
ABT‐200 dose: 20 mg/day |
| Outcomes |
HDRS‐21, Montgomery–Åsberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI), HAM‐A |
| Notes |
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomised, no further information |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "patients in the ABT‐200 group received one placebo capsule which resembled fluoxetine", not clear if blindness was successful |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Number and reasons for dropout reported, but included in the analysis only by estimation of outcome |
| Selective reporting (reporting bias) |
Unclear risk |
End point scores (MADRS, CGI) not reported. Only side effects reported by at least 20% of the sample reported |
| Other bias |
High risk |
Funding: by industry. (Abbott Laboratories, Abbott Park) |
