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

NCT00452595

Last updated date
Contact
1-800-718-1021

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

By email

Contact

[email protected]

Call Now

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.
Show details

- 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.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Major Depressive DisorderA Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression NCT00644982
  1. Cairns, Queensland
  2. Everton Park, Queensland
  3. North Cairns, Queensland
  4. Box Hill, Victoria
  5. Heidelberg, Victoria
  6. West Heidelberg, Victoria
  7. West Perth, Western Australia
  8. Adana,
  9. Ankara,
  10. Diyarbakir,
  11. Istanbul,
  12. Izmir,
  13. Izmit,
  14. Malatya,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Major Depressive DisorderStudy Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder NCT00384033
  1. Beverly Hills, California
  2. Burbank, California
  3. Encino, California
  4. Los Alamitos, California
  5. Newport Beach, California
  6. Northridge, California
  7. Orange, California
  8. Pasadena, California
  9. Upland, California
  10. South Miami, Florida
  11. St. Petersburg, Florida
  12. Edwardsville, Illinois
  13. Farmington Hills, Michigan
  14. Flint, Michigan
  15. Okemos, Michigan
  16. Clementon, New Jersey
  17. Dayton, Ohio
  18. Portland, Oregon
  19. Philadelphia, Pennsylvania
  20. Salt Lake City, Utah
  21. Seattle, Washington
  22. Brown Deer, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Major Depressive DisorderRelapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder NCT00887224
  1. Beverly Hills, California
  2. Encino, California
  3. Los Alamitos, California
  4. Orange, California
  5. Upland, California
  6. Aurora, Colorado
  7. Jacksonville, Florida
  8. South Miami, Florida
  9. St. Petersburg, Florida
  10. St. Petersburg, Florida
  11. Atlanta, Georgia
  12. Smyrna, Georgia
  13. Hoffman Estates, Illinois
  14. Rockville, Maryland
  15. New York, New York
  16. New York, New York
  17. Rochester, New York
  18. Dayton, Ohio
  19. Portland, Oregon
  20. San Antonio, Texas
  21. Seattle, Washington
  22. Edmonton, Alberta
  23. Medicine Hat, Alberta
  24. Kelowna, British Columbia
  25. Vancouver, British Columbia
  26. Bathurst, New Brunswick
  27. Burlington, Ontario
  28. Ottawa, Ontario
  29. Toronto, Ontario
  30. Gatineau, Quebec
  31. Pointe-Claire, Quebec
  32. Sherbrooke, Quebec
  33. Santiago,
  34. Santiago,
  35. Santiago,
  36. Medellin, Antioquia
  37. Barranquilla, Atlantico
  38. Bogota, Cundinamarca
  39. Bucamaranga, Santander
  40. Rijeka,
  41. Zagreb,
  42. Tallinn,
  43. Tallinn,
  44. Tartu,
  45. Voru,
  46. Vöru,
  47. Espoo,
  48. Helsinki,
  49. Joensuu,
  50. Kuopio,
  51. Seinajoki,
  52. Tampere,
  53. Turku,
  54. Caen,
  55. Dole,
  56. Douai,
  57. Orvault,
  58. Rennes,
  59. Liepaja,
  60. Sigulda,
  61. Sigulda,
  62. Strenci,
  63. Kaunas,
  64. Kaunas,
  65. Vilius,
  66. Vilnius,
  67. Vilnius,
  68. Vilnius,
  69. Skorzewo, Poznan
  70. Szczecin,
  71. Torun,
  72. Tuszyn,
  73. Wroclaw,
  74. Zuromin,
  75. Craiova, Dolj
  76. Brasov,
  77. Bucharest,
  78. Bucuresti,
  79. Bucuresti,
  80. Cluj Napoca,
  81. Bojnice,
  82. Bratislava,
  83. Liptovsky Mikulas,
  84. Michalovce,
  85. Rimavska Sobota,
  86. Trencin,
  87. Cape Town, Western Cape
  88. Durban,
  89. Paarl,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Major Depressive DisorderStudy Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD) NCT01056289
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive Disorder
Official Title  ICMJE A 12-Month Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Outpatients With Major Depressive Disorder
Brief Summary To evaluate the long-term safety of desvenlafaxine sustained release (DVS-233SR) during open-label treatment of outpatients with major depressive disorder (MDD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: DVS-233 SR (desvenlafaxine sustained release )
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
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, 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 NCT00452595
Other Study ID Numbers  ICMJE 3151A1-318
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP