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Study Evaluating DVS-233 SR in Elderly Outpatients With Major Depressive Disorder

Last updated on November 11, 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
65 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00242229
Pfizer
Completed
Study Evaluating DVS-233 SR in Elderly Outpatients With Major Depressive Disorder

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Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
Descriptive Information
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 SummaryTo 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 DescriptionNot 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
 (submitted: August 18, 2009)
52
Original Enrollment  ICMJE
 (submitted: October 17, 2005)
75
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion DateOctober 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateAugust 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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