ISRCTN87057460.
| Methods | This is a three‐arm, randomised, parallel study designed to assess the inhibition of noradrenaline and 5‐HT uptake by venlafaxine, paroxetine and atomoxetine. Approximately 40 depressed patients will be randomised to one of three treatment groups with the goal of having at least 10 participants complete the study in each group. The investigators involved in the tyramine test or the collecting of biochemical data will be blind to the medications used by patients. This study will be conducted on an outpatient basis |
| Participants |
Inclusion criteria 1. Male or female patients between 18 and 65 years of age 2. Diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM‐IV) (American Psychiatry Association, 1994) using the Structured Clinical Interview for Depression (SCID) (Spitzer 1992) 3. Initial global score 18 on the 17‐item HRSD 4. Written informed consent signed by the participant Exclusion criteria 1. Evidence of significant physical illness contraindicating the use of venlafaxine, paroxetine or atomoxetine found on physical or in the laboratory data obtained during the first week of the study 2. Evidence of suicidality or severity of depression precluding safe participation in the study 3. Mental retardation (IQ lower than 80) rendering the response to investigators unreliable 4. Pregnancy, or absence of adequate contraceptive method in women with childbearing potential 5. Concurrent use of psychotropic medication such as antipsychotics, mood stabilisers or regular use of high doses of benzodiazepines 6. Lack of response or intolerance to optimal doses of paroxetine, venlafaxine or atomoxetine 7. Participation in another clinical trial within 30 days of entry into the current study Interventions |
| Interventions | Venlafaxine, paroxetine and atomoxetine |
| Outcomes | The primary objective of this study is to find evidence of a dose‐dependent inhibition of noradrenaline reuptake starting of venlafaxine at 150 mg/day. A secondary objective of this study is to show a lack of effect of paroxetine on noradrenaline reuptake at doses of up to 50 mg/day |
| Notes |