Methods | Twelve-week double-blind, randomised, multicentre study. | |
Participants | Outpatients with a score between 18 and 25 on the HDRS-21 and minimum baseline of 8 on the Covi Anxiety Scale, and considered by the investigator to be moderately depressed. Age range: 18-70. Exclusion criteria: pregnancy, chilbearing potential, absence of contraceptive method, psychiatric disease or personality disorder, known clinically significant laboratory abnormalities, use of antipsychotic drug or ECT within 30 days of baseline, use of fluoxetine within 21 and MAOI within 14 of baseline; patients who previously failed to respond to venlafaxine or fluoxetine, high suicide risk |
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Interventions | Fluoxetine: 73 participants. Venlafaxine: 73 participants. Fluoxetine dose range: 20-40 mg/day. Venlafaxine dose range: 75-150 mg/day. Lormetazepam was allowed (2 mg) as hypnotic. |
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Outcomes | Primary outcomes: Hamilton Rating Scale for Depression (HDRS-21), Montgomery and Asberg Scale for Depression (MADRS), CGI-Severity of Illness. Secondary outcome: Covi Anxiety Scale. |
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Notes | Response: decrease of at least 50% in the HAM-D or in the MADRS total score. Remission: total score less than 8 on the HDRS-21. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |