Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

Wyeth

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Paroxetine; Drug: DVS SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445679

3151A1-336

Details and patient eligibility

About

This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

Full description

The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.

Enrollment: 807 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Primary Inclusion Criteria:

1. Outpatient men and women at least 18 years of age.
2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.

Primary Exclusion Criteria:

1. Treatment with DVS SR at any time in the past.
2. Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
3. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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807 participants in 4 patient groups

A

Experimental group

Description:

DVS SR 50mg/day

Treatment:

Drug: DVS SR

B

Experimental group

Description:

DVS SR 100mg/day

Treatment:

Drug: DVS SR

C

Experimental group

Description:

DVS SR 200mg/day

Treatment:

Drug: DVS SR

D

Active Comparator group

Description:

Paroxetine 20mg/day

Treatment:

Drug: Paroxetine