Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Venlafaxine Hydrochloride

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.