Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
Primary Purpose
Anxiety Disorders, Depression
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Venlafaxine XR
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
The primary endpoint is the change from baseline to Week 12 in the PHQ-15 total score.
Secondary Outcome Measures
Efficacy will be evaluated by changes in the total scores of the HAM-D17, HAM-A, CGI, MQOL-PS, VAS and SF-36. Safety will be monitored by collecting spontaneously reported adverse events; vital signs and laboratory measures according to the Schedule.
Full Information
NCT ID
NCT00546923
First Posted
October 18, 2007
Last Updated
October 18, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00546923
Brief Title
Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
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).
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
210 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Venlafaxine XR
Primary Outcome Measure Information:
Title
The primary endpoint is the change from baseline to Week 12 in the PHQ-15 total score.
Secondary Outcome Measure Information:
Title
Efficacy will be evaluated by changes in the total scores of the HAM-D17, HAM-A, CGI, MQOL-PS, VAS and SF-36. Safety will be monitored by collecting spontaneously reported adverse events; vital signs and laboratory measures according to the Schedule.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
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