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

NCT01101152 | Unknown Phase 1

• 1 other identifier: REB-2009036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Antidepressant; healthy volunteers; desvenlafaxine succinate; norepinephrine reuptake; serotonin reuptake; tyramine test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The degree of serotonin reuptake in response to the increasing levels of the study medication will be assessed and compared between genders

  1 month

Study Arms (2)

Female

EXPERIMENTAL

Drug: Desvenlafaxine succinate

Male

EXPERIMENTAL

Drug: Desvenlafaxine succinate

Interventions

Desvenlafaxine succinate DRUG

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

Also known as: Pristiq

Female; Male

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa Institute of Mental Health Research

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

Related Links

• University of Ottawa Institute of Mental Health Research homepage

MeSH Terms

Interventions

Desvenlafaxine Succinate

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Study Officials

• Pierre Blier, M.D., Ph.D.

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Chernoloz, B.Sc.Pharm

CONTACT

613-722-6521; olga.chernoloz@rohcg.on.ca

Wendy Fusee, RN

CONTACT

613-722-6521; wendy.fusee@rohcg.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 9, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 8, 2011

Record last verified: 2010-04

Locations

CA (1)