Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)
NCT01441440
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Outpatient status.
- A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
- Depressive symptoms for at least 90 days in single episode and for at least 28 days in recurrent episode before the screening visit.
- A MADRS total score ≥26 at the screening and baseline visits. And change of MADRS total score at baseline is not over 25% from the screening visit.
- A QIDS16-J-SR score ≥16 at the screening and baseline visits.
- A score ≥4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening and baseline visits.
- Subjects who concurrently have Axis II personality disorder or mental retardation
according to DSM-IV diagnostic criteria.
- Subjects who meet DSM-IV criteria for current or past history of Schizophrenia,
Paranoid Disorders, or any other Psychotic Disorders.
- Subjects who meet DSM-IV criteria for current or past history of Dementia.
- Subjects who meet DSM-IV criteria for current or past history of bipolar disorder,
Posttraumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD).
- Subjects who meet DSM-IV criteria for current (within 12 months before the screening
visit) generalized anxiety disorder, panic disorder, or social anxiety disorder
considered by the investigator to be primary (causing a higher degree of distress or
impairment than MDD).
- Subjects with a first degree relative with bipolar disorder.
- Subjects who are actively suicidal.
- History of non-responsive to 2 antidepressant treatment (at least 6-week usage for
each) for the past or current episodes.
- History of Electroconvulsive therapy (ECT) at any time in the past.
- History of chronic treatment with benzodiazepines for longer than 6 months before the
screening visit (Excluding subjects who have taken PRN benzodiazepine use, < 3
times/week).
- Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
hypertension), ophthalmologic, neurologic, or any other medical condition that in the
investigator's judgment, will substantially increase the risk associated with the
subject's participation in and completion of, the study.
- Known presence of raised intraocular pressure or history or presence of narrow angle
glaucoma.
- Myocardial infarction within 180 days of the screening visit.
- Clinically important abnormalities, as determined by the investigator, on screening
physical examination, electrocardiogram (ECG) or laboratory tests.
- Use of prohibited treatments
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Nashville, Tennessee
- Madison, Wisconsin
- Tokyo,
- Vancouver, British Columbia
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD) | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder | |||
Brief Summary | This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The follow-up visit will be evaluated after 2 weeks of last study medication dosing. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Major Depressive Disorder | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 538 | |||
Original Estimated Enrollment ICMJE | 534 | |||
Actual Study Completion Date ICMJE | March 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01441440 | |||
Other Study ID Numbers ICMJE | B2411263 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |