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Status unknownNCT01101152DVSUpdated Aug 8, 2011

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

A Phase 1 interventional study of Desvenlafaxine succinate in Healthy, sponsored by University of Ottawa. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-08.

Sponsored by University of Ottawa · Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Apr 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Antidepressant
  • healthy volunteers
  • desvenlafaxine succinate
  • norepinephrine reuptake
  • serotonin reuptake
  • tyramine test
03

In context

Lead sponsor

University of Ottawa is the lead sponsor of 122 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Female

    Drug: Desvenlafaxine succinate

  • Experimental
    Male

    Drug: Desvenlafaxine succinate

Interventions

  • DrugDesvenlafaxine 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

    Also known as: Pristiq

06

What researchers measure

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

    Time frame: 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

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • University of Ottawa Institute of Mental Health Research
    Ottawa, Ontario K1Z 7K4, Canada
    • Olga Chernoloz, B.Sc.Pharm · Contact · olga.chernoloz@rohcg.on.ca · 613-722-6521
    • Pierre Blier, M.D., Ph.D. · Principal investigator
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01101152
Lead sponsor
University of Ottawa
First posted
Apr 9, 2010
Start date
Apr 2010
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Aug 8, 2011

Study contacts

Olga Chernoloz, B.Sc.Pharm
Contact
olga.chernoloz@rohcg.on.ca
613-722-6521 ext. 6405
Wendy Fusee, RN
Contact
wendy.fusee@rohcg.on.ca
613-722-6521
Pierre Blier, M.D., Ph.D.
principal investigator · University of Ottawa

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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