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Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
This study has been completed.
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00546923
  Purpose

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).


Condition Intervention Phase
Anxiety Disorders
Depression
Drug: Venlafaxine XR
Phase IV

MedlinePlus related topics: Anxiety Depression
Drug Information available for: Venlafaxine Venlafaxine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

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.

Estimated Enrollment: 210
Study Start Date: August 2004
Study Completion Date: June 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546923

Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

Study ID Numbers: 0600B-101568
Study First Received: October 18, 2007
Last Updated: October 18, 2007
ClinicalTrials.gov Identifier: NCT00546923  
Health Authority: Taiwan: Department of Health

Study placed in the following topic categories:
Depression
Anxiety Disorders
Mental Disorders
Venlafaxine
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Serotonin Uptake Inhibitors
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009