Study Evaluating DVS-233 SR in Elderly Outpatients With Major Depressive Disorder
NCT00242229
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- Outpatients men and women aged 65 years or older.
- Mini Mental State Examination score of 24 or above.
- 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 depressive symptoms for at least 30 days prior to screening visit and minimum screening and study day -1 (baseline) scores of 16 on the Hamilton Psychiatric Rating Scale for Depression (HAM-D17).
- 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.
- 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). Presence of dementia.
- Depression associated with the presence of an organic mental disorder due to a general
medical condition or a neurologic disorder.
Other exclusion applies.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating DVS-233 SR in Elderly Outpatients With Major Depressive Disorder | |||
Official Title ICMJE | A 6 Month, Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Elderly Outpatients With Major Depressive Disorder (MDD) | |||
Brief Summary | To evaluate the overall safety and tolerability profile of two dose levels of DVS-233 SR during 6 months of open-label treatment in elderly outpatients with major depressive disorder. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | |||
Condition ICMJE | Major Depressive Disorder | |||
Intervention ICMJE | Drug: DVS-233 SR | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 52 | |||
Original Enrollment ICMJE | 75 | |||
Actual Study Completion Date ICMJE | October 2005 | |||
Actual Primary Completion Date | October 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other exclusion applies. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 65 Years and older (Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00242229 | |||
Other Study ID Numbers ICMJE | 3151A1-307 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | August 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |