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

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00452595
Pfizer
Completed
Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive Disorder

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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