Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorders; Depression
Intervention: Venlafaxine XR (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: The primary endpoint is the change from baseline to Week 12 in the PHQ-15 total score.
Secondary outcome: 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.
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
ยท 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.
Locations and Contacts
Additional Information
Starting date: August 2004
Last updated: October 18, 2007
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