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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Ottawa.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Ottawa
ClinicalTrials.gov Identifier:
NCT01101152
First received: April 8, 2010
Last updated: August 4, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Desvenlafaxine succinate
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Females and Males

Resource links provided by NLM:


Further study details as provided by University of Ottawa:

Primary Outcome Measures:
  • The degree of norepinephrine reuptake in response to the increasing levels of the study medication will be assessed and compared between genders [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The degree of serotonin reuptake in response to the increasing levels of the study medication will be assessed and compared between genders [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Female 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

Other Name: Pristiq
Experimental: Male 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

Other Name: Pristiq

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101152

Contacts
Contact: Olga Chernoloz, B.Sc.Pharm 613-722-6521 ext 6405 olga.chernoloz@rohcg.on.ca
Contact: Wendy Fusee, RN 613-722-6521 wendy.fusee@rohcg.on.ca

Locations
Canada, Ontario
University of Ottawa Institute of Mental Health Research Recruiting
Ottawa, Ontario, Canada, K1Z 7K4
Contact: Olga Chernoloz, B.Sc.Pharm    613-722-6521 ext 6405    olga.chernoloz@rohcg.on.ca   
Principal Investigator: Pierre Blier, M.D., Ph.D.         
Sponsors and Collaborators
University of Ottawa
Investigators
Principal Investigator: Pierre Blier, M.D., Ph.D. University of Ottawa Institute of Mental Health Research
  More Information

Additional Information:
No publications provided

Responsible Party: Pierre Blier, MD, Ph.D., University of Ottawa Institute of Mental Health Research
ClinicalTrials.gov Identifier: NCT01101152     History of Changes
Other Study ID Numbers: REB-2009036
Study First Received: April 8, 2010
Last Updated: August 4, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa:
Antidepressant
healthy volunteers
desvenlafaxine succinate
norepinephrine reuptake
serotonin reuptake
tyramine test

Additional relevant MeSH terms:
Norepinephrine
Serotonin
O-desmethylvenlafaxine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014