Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Volunteers

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Females and Males

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Desvenlafaxine succinate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Female<br> | Drug: Desvenlafaxine succinate<br>* 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<br>* Other names: Pristiq;|
| Experimental: Male<br> | Drug: Desvenlafaxine succinate<br>* 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<br>* Other names: Pristiq;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant, healthy volunteers, desvenlafaxine succinate, norepinephrine reuptake, serotonin reuptake, tyramine test