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Study Evaluating DVS-233 in A...

Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder

Last Updated: 2009-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2004-05-31

Brief Summary

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Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D\<sub\>17\</sub\>\] \< 7) versus those subjects receiving placebo.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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DVS-233 SR

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a primary diagnosis of major depressive disorder (MDD)
* Depressive symptoms for at least 30 days prior to the screening visit
* Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D\<sub\>17\</sub\>)

Exclusion Criteria

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers