Recruiting
Phase 1

Desvenlafaxine

Sponsor:

University of Ottawa

Code:

NCT01101152

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Desvenlafaxine succinate

Study Details

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

Study ID

NCT01101152

Start date

Apr, 2010

Status verified date

Apr, 2010

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Female

experimental: Male

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Olga Chernoloz, B.Sc.Pharm

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

Wendy Fusee, RN

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

Locations

University of Ottawa Institute of Mental Health Research

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Olga Chernoloz, B.Sc.Pharm

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

Principal Investigator:

Pierre Blier, M.D., Ph.D.

More Information

Sponsor

University of Ottawa

Last update posted

Aug 8, 2011

Last verified

Apr, 2010

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2011-08-08.