Major Depressive Disorder Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Parallel-group Study of Sertraline vs. Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder
Verified date | June 2015 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a randomized, double-blind, active control, 8-week, flexible dose study of sertraline vs. venlafaxine Extended Release in the acute treatment of Major Depression in male and female outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in a 1:1 ratio to receive either sertraline or venlafaxine XR based on a computer-generated randomized list.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Single or Recurrent Episode of MDD without psychotic features - Additional diagnoses will be permitted only if they are identified as secondary diagnoses - 18 or above on 17-item Ham-D with item 1 (depressed mood) score of 2 or above Exclusion Criteria: - Current or past diagnosis of Bipolar Disorder - Any history or current psychotic disorder - Current psychotic symptoms, including current delusional depression - Current diagnosis of delirium or dementia - Alcohol or drug abuse or dependence in last 6 months or currently - Schizoid, Schizotypal, or Borderline Personality Disorder - Non-response to sertraline at least 150mg for 4 weeks or more, venlafaxine XR at least 225mg for 4 weeks or more, or non-response to 2 antidepressants in the current episode - Use of any antidepressant within 2 weeks of baseline (4 weeks for fluoxetine) - Use of herbal and/or homeopathic remedies concomitantly or within 2 weeks of baseline excluding vitamins and mineral supplements - Use within 1 week of baseline or concomitant use of any psychotropics with the exception zolpidem or zopiclone PRN for sleep - Use within 4 weeks of baseline of benzodiazepines taken on a regular, daily basis (PRN use is acceptable as long as none in week leading up to randomization) - Score of 3 or 4 on the suicide item, item 3 of the Ham-D scale at screen or baseline visit - Participation in any other studies concomitantly or within 90 days prior to entry into this study - Treatment with monoamine oxidase inhibitors within 14 days of baseline - Treatment of electroconvulsive therapy within 30 days of baseline - Previous history or intolerance or hypersensitivity and/or venlafaxine XR - Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol - Presence of serious and/or unstable medical condition - Abnormal laboratory results - Positive pregnancy test and/or nursing women or fertile women not practicing an effective method of birth control - History seizure disorder-excluding febrile seizures of childhood - Any other condition which in the investigator's judgement might increase the risk to the subject or decrease the chance of obtaining satisfactory data - Mental condition rendering the subject unable to understand the procedures - Unable and/or unlikely to comprehend and/or follow the protocol |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ham-D (Hamilton Depression Rating Scale for Depression) 17-item | |||
Primary | Clinical Global Impression - Severity Scale | |||
Primary | Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | |||
Primary | Treatment Emergent Symptom Scale-Revised (TESS-R) | |||
Primary | Brief Symptom Inventory (BSI) | |||
Secondary | NEO-5 factor Inventory (NEO-FFI) | |||
Secondary | Anxiety Sensitivity Inventory (ASI) | |||
Secondary | Mood Disorder Questionnaire (MDQ) | |||
Secondary | Ham-A (Hamilton Rating Scale for Anxiety) | |||
Secondary | Arizona Sexual Functioning Inventory (A-SEX) | |||
Secondary | Atypical Features Inventory |
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