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

Information source: University of Ottawa
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Desvenlafaxine succinate (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Ottawa

Official(s) and/or principal investigator(s):
Pierre Blier, M.D., Ph.D., Principal Investigator, Affiliation: University of Ottawa Institute of Mental Health Research

Overall contact:
Olga Chernoloz, B.Sc.Pharm, Phone: 613-722-6521, Ext: 6405, Email: olga.chernoloz@rohcg.on.ca

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.

Clinical Details

Official title: Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Females and Males

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: The degree of norepinephrine reuptake in response to the increasing levels of the study medication will be assessed and compared between genders

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

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

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

Locations and Contacts

Olga Chernoloz, B.Sc.Pharm, Phone: 613-722-6521, Ext: 6405, Email: olga.chernoloz@rohcg.on.ca

University of Ottawa Institute of Mental Health Research, Ottawa, Ontario K1Z 7K4, Canada; Recruiting
Olga Chernoloz, B.Sc.Pharm, Phone: 613-722-6521, Ext: 6405, Email: olga.chernoloz@rohcg.on.ca
Pierre Blier, M.D., Ph.D., Principal Investigator
Additional Information

University of Ottawa Institute of Mental Health Research homepage

Starting date: April 2010
Last updated: August 4, 2011

Page last updated: August 23, 2015

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