Major Depression Mental and Behavioural Disorders Depression
Conditions
Interventions
This is a three-arm, randomized, parallel study designed to assess the inhibition of NE and 5-HT uptake by Venlafaxine, Paroxetine and Atomoxetine. Approximately 40 depressed patients will be randomiz
Sponsors
Wyeth Pharmaceuticals (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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 Hamilton depression rating scale 4. Written informed consent signed by the patient
Exclusion criteria
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 stabilizers 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to find evidence of a dose-dependent inhibition of NE reuptake starting of Venlafaxine at 150 mg/day. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary objective of this study is to show a lack of effect of Paroxetine on NE reuptake at doses of up to 50 mg/day. Another secondary objective is to show a lack of effect of Atomoxetine on 5-HT reuptake and a similar action of higher doses of Venlafaxine and Atomoxetine on NE reuptake. A third secondary objective is to show a marked effect of Paroxetine and Venlafaxine on 5-HT reuptake starting at low doses. | — |
Countries
Canada
Outcome results
None listed