NCT00366652

Brief Summary

The purpose of this study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3 depression

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

May 28, 2007

Status Verified

May 1, 2007

First QC Date

August 17, 2006

Last Update Submit

May 25, 2007

Conditions

DepressionDepressive DisorderDepressive Disorder, Major

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.

Interventions

desvenlafaxine SRDRUG
desipramineDRUG
duloxetineDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
1. Healthy men and women between 18 to 55 years of age. 2. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs and a 12-lead electrocardiogram. 3. History of being a nonsmoker for a least 1 year.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neptune City, New Jersey, 07753, United States

Location

MeSH Terms

Conditions

DepressionDepressive DisorderDepressive Disorder, Major

Interventions

DesipramineDuloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

September 1, 2006

Study Completion

September 1, 2006

Last Updated

May 28, 2007

Record last verified: 2007-05

Locations

US(1)