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

Healthy Clinical Trial

— DVS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01101152
• Other study ID #: REB-2009036
• Status: Recruiting
• Phase: Phase 1
• First received: April 8, 2010
• Last updated: August 4, 2011
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2010
• Source: University of Ottawa
• Contact: Olga Chernoloz, B.Sc.Pharm
• Phone: 613-722-6521
• Email: olga.chernoloz[@]rohcg.on.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Desvenlafaxine succinate
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

Locations

Country	Name	City	State
Canada	University of Ottawa Institute of Mental Health Research	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of norepinephrine reuptake in response to the increasing levels of the study medication will be assessed and compared between genders		1 month	No
Secondary	The degree of serotonin reuptake in response to the increasing levels of the study medication will be assessed and compared between genders		1 month	No

External Links

•   University of Ottawa Institute of Mental Health Research homepage