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

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: DVS-233 SR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00063206
3151A1-304

Details and patient eligibility

About

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.

Enrollment

247 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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