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Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive Disorder

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: DVS-233 SR (desvenlafaxine sustained release ) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Summary

To evaluate the long-term safety of desvenlafaxine sustained release (DVS-233SR) during open-label treatment of outpatients with major depressive disorder (MDD).

Clinical Details

Official title: A 12-Month Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Outpatients With Major Depressive Disorder

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: HAM-D17

Secondary outcome: MADRS, CGI-S, CGI-I, Covi Anxiety Scale, SDS, VAS-PI, and WHO-5

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients.

- Men and women aged 18 to 75 years.

- Women of childbearing potential must have a negative serum pregnancy test result at

screening. Sexually active individuals participating in this study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article.

- Subjects must 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, on study day 1. If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present. (See Exclusion Criterion 6 for psychiatric diagnoses that are not allowable.)

- Depressive symptoms for at least 30 days before the screening visit.

- Subjects who have symptoms of depression judged by the investigator to require

long-term treatment (i. e., 6 months or longer) with an antidepressant drug. Other inclusion applies. 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).

- Significant risk of suicide based on clinical judgment, including common suicidal

thoughts, and suicide being considered as a possible solution, even without specific plans or intention.

- Women who are pregnant, breastfeeding, or planning to become pregnant during the

study.

- Current (within 12 months of baseline) psychoactive substance abuse or dependence

(including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified Mini International Neuropsychiatric Interview (MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary, causing a higher degree of distress or impairment than MDD. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic).

- Depression associated with the presence of an organic mental disorder due to a

general medical condition or a neurologic disorder.

- History of a seizure disorder other than a single childhood febrile seizure.

Other exclusion applies.

Locations and Contacts

Additional Information

Starting date: January 2004
Last updated: March 23, 2007

Page last updated: August 23, 2015

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