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CompletedNCT00546923Updated Oct 19, 2007

Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients

A Phase 4 interventional study of Venlafaxine XR in Anxiety Disorders and Depression, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-19.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Anxiety Disorders
  • Depression

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 210 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

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Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
210 participants

Interventions

  • DrugVenlafaxine XR
06

What researchers measure

Primary outcomes

  1. The primary endpoint is the change from baseline to Week 12 in the PHQ-15 total score.

Secondary outcomes

  1. 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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00546923
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Oct 19, 2007
Start date
Aug 2004
Completion
Jun 2006
Last update
Oct 19, 2007

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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