Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-02-28

Brief Summary

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Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Desvenlafaxine Succinate Sustained-Release Formulation 50 mg

Group Type ACTIVE_COMPARATOR

Desvenlafaxine Succinate Sustained-Release Formulation 50 mg

Intervention Type DRUG

DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.

Desvenlafaxine Succinate Sustained-Release Formulation 25 mg

Group Type ACTIVE_COMPARATOR

Desvenlafaxine Succinate Sustained-Release Formulation 25 mg

Intervention Type DRUG

DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.

Interventions

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Desvenlafaxine Succinate Sustained-Release Formulation 50 mg

DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.

Intervention Type DRUG

Desvenlafaxine Succinate Sustained-Release Formulation 25 mg

DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.

Intervention Type DRUG

Placebo

DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primary Diagnosis of Major Depressive Disorder
* Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline

Exclusion Criteria

* Current psychoactive substance abuse or dependence, manic episode, or a lifetime diagnosis of bipolar or psychotic disorder
* Potentially violent to others or is at significant risk for suicide
* History or current evidence of gastrointestinal disease or history of surgery known to interfere with absorption or excretion
* Known presence of raised intraocular pressure or history of narrow angle glaucoma

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No