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Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
This study has been completed.
First Received: October 18, 2007   No Changes Posted
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

No publications provided

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

Study placed in the following topic categories:
Neurotransmitter Agents
Depression
Anxiety Disorders
Mental Disorders
Venlafaxine
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Depressive Disorder
Serotonin Uptake Inhibitors
Antidepressive Agents
Serotonin
Behavioral Symptoms

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

ClinicalTrials.gov processed this record on May 07, 2009