A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression
| City: |
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Wichita Falls |
| State: |
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Texas |
| Zip Code: |
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76309 |
| Conditions: |
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Depression |
| Purpose: |
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The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836
in patients with depression.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Men and women of age 18-65 years (Argentina the minimum age will be 24 years of age)
- Patients randomized in parent study who complete CN162-006 and CN162-007 who consent
to enter the rollover study.
- Patient not randomized in parent study that meet inadequate response criteria
Exclusion Criteria:
- Patients who represent a significant risk of committing suicide based on the clinical
judgment of the investigator, history or routine psychiatric status exam.
- Patients with a Cardiovascular System Organ Class adverse event(s) occurring in
parent study (CN162-006 or CN162-007), that in the investigators judgment is
clinically significant and would impact safety of the subject in the current study
[including but not limited to left bundle branch block, or prolonged QT interval
corrected (QTc)].
- In addition, patients should be excluded if they have any laboratory test, vital
sign, electrocardiogram (ECG) or clinical findings that in the investigator's
judgment is clinically significantly abnormal and could impact the safety of the
patient or the interpretation of study assessments in the current study.
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| NCT ID: |
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NCT01361555 |
| Primary Contact: |
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Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb
For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email: Clinical.Trials@bms.com
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| Backup Contact: |
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First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
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| Location Contact: |
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Wichita Falls, Texas 76309
United States
Benny L. Barnhart, Site 057
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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