Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- The primary endpoint is the change from baseline to Week 12 in the PHQ-15 total score.
- 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 |
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 |
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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00546923 History of Changes |
| Other Study ID Numbers: | 0600B-101568 |
| Study First Received: | October 18, 2007 |
| Last Updated: | October 18, 2007 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Mental Disorders Behavioral Symptoms Mood Disorders Venlafaxine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013