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

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ClinicalTrials.gov Identifier: NCT01101152
Recruitment Status : Unknown
Verified April 2010 by University of Ottawa.
Recruitment status was:  Recruiting
First Posted : April 9, 2010
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
University of Ottawa

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Desvenlafaxine succinate Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Females and Males
Study Start Date : April 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: April 2010

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

Additional relevant MeSH terms:
Serotonin
Norepinephrine
Desvenlafaxine Succinate
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents
Psychotropic Drugs