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Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anxiety Disorders, Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

· Subjects must be at least 18 years of age and meet DSM-IV diagnostic criteria for major
depressive disorder, generalized anxiety disorder, and/ or social anxiety disorder, meet
clinical criteria for MSD, have a total score of greater than or equal to 14 on the HAM-D17
or a total score of greater than or equal to 12 on the HAM-A at screening and no more than
a 25% decrease in total HAM-D17 score or total HAM-A score from screening to randomization.

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

- a history of an inability to tolerate or failure to respond to greater than or equal
to 2 antidepressants of sufficient dose and duration of administration for the
treatment of symptoms present in the current illness;

- a current or past history of mania, bipolar disorder, schizophrenia, or other
psychotic disorder;

- history of seizure disorder other than childhood febrile seizure;

- presence of a serious or clinically unstable medical illness or psychiatric condition
that would compromise the participation in the study;

- previous intolerance or hypersensitivity to venlafaxine or venlafaxine XR or
nonresponse to a previous adequate trial of any of these drugs, or use of any
nonpsychopharmacologic drug with psychotropic effects within 7 days of study
randomization;

- Use of MAOI or fluoxetine within 30 days of screening; or

- Use of ECT within 3 months of screening.

NCT00546923
Pfizer
Completed
Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients

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Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study To Evaluate The Efficacy And Safety Of Venlafaxine Extended-Release In Depressed And Anxious Patients With Multiple, Unexplained Somatic Symptoms
To examine the efficacy and safety of venlafaxine XR in the treatment of physical and emotional symptoms in patients with an operationally-defined diagnosis of multisomatoform disorder (MSD).
The purpose of this study is to examine the efficacy and safety of venlafaxine XR in the treatment of physical and emotional symptoms in patients with an operationally-defined diagnosis of MSD. Primary efficacy will be evaluated using the PHQ-15 scale, and secondary efficacy will be evaluated using the HAM-D17, HAM-A, CGI, MQOL-PS, VAS and SF-36 evaluation scales. Assessment scales and questionnaires will be administered at specified clinical visits between screening and Week 12 (or discontinuation).
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Anxiety Disorders
  • Depression
Drug: Venlafaxine XR
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
June 2006
Not Provided

Inclusion Criteria:

· Subjects must be at least 18 years of age and meet DSM-IV diagnostic criteria for major depressive disorder, generalized anxiety disorder, and/ or social anxiety disorder, meet clinical criteria for MSD, have a total score of greater than or equal to 14 on the HAM-D17 or a total score of greater than or equal to 12 on the HAM-A at screening and no more than a 25% decrease in total HAM-D17 score or total HAM-A score from screening to randomization.

Exclusion Criteria:

  • a history of an inability to tolerate or failure to respond to greater than or equal to 2 antidepressants of sufficient dose and duration of administration for the treatment of symptoms present in the current illness;
  • a current or past history of mania, bipolar disorder, schizophrenia, or other psychotic disorder;
  • history of seizure disorder other than childhood febrile seizure;
  • presence of a serious or clinically unstable medical illness or psychiatric condition that would compromise the participation in the study;
  • previous intolerance or hypersensitivity to venlafaxine or venlafaxine XR or nonresponse to a previous adequate trial of any of these drugs, or use of any nonpsychopharmacologic drug with psychotropic effects within 7 days of study randomization;
  • Use of MAOI or fluoxetine within 30 days of screening; or
  • Use of ECT within 3 months of screening.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00546923
0600B-101568
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2007

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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