Healthy
Conditions
Keywords
Antidepressant, healthy volunteers, desvenlafaxine succinate, norepinephrine reuptake, serotonin reuptake, tyramine test
Brief summary
DVS is the main metabolite of the antidepressant/anxiolytic medication Venlafaxine (Effexor). Like parent compound, DVS is an antidepressant inhibiting both serotonin (5-HT) and norepinephrine (NE) reuptake. However, no studies to date describe the in vivo potency of this drug on monoamines reuptake. Consequently, it appears essential to determine the potency of DVS in human subjects using a wide dose range in order to determine at which dose(s) it starts inhibiting 5-HT and NE reuptake. The investigators are interested in learning whether there is a gender difference in the dose of the study medication at which NE reuptake inhibition occurs.
Interventions
Tablets of 50 mg,100 mg; Dosing regimen: 50, 100, 200 mg/day; 1 week for each dose regimen; 1 tablet a day for doses of 50 and 100mg/day, and 2 tablets of 100mg for dose of 200mg/day
Sponsors
University of Ottawa
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Female subjects between 18 and 40 years of age, including those on oral contraceptive pills * Male subjects between 18-40 years of age * Written informed consent signed by the subject.
Exclusion criteria
* Life-time personal history of diagnosis of major depression according to the DSM-IV (American Psychiatry Association, 1994) using the MINI (Sheehan et al. 1998) * Blood pressure greater than 140/90 and a pulse rate greater than 90bpm * Evidence of significant physical illness contraindicating the use of DVS, found on physical or in the laboratory data obtained during the first week of the study * Obvious mental retardation rendering the response to investigators unreliable * Pregnancy, or absence of adequate contraceptive method. * Concurrent use of psychotropic medication such as antipsychotics, mood stabilizers or regular use of benzodiazepines. * Participation in a clinical trial within 30 days of entry into the current study * Intolerance to Desvenlafaxine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of norepinephrine reuptake in response to the increasing levels of the study medication will be assessed and compared between genders | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| The degree of serotonin reuptake in response to the increasing levels of the study medication will be assessed and compared between genders | 1 month |
Countries
Canada
Contacts
Primary ContactOlga Chernoloz, B.Sc.Pharm
Backup ContactWendy Fusee, RN
Outcome results
None listed