Assessing Symptomatic Clinical Episodes in Depression (ASCEND)
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ClinicalTrials.gov Identifier: NCT03595579 |
Recruitment Status :
Completed
First Posted : July 23, 2018
Last Update Posted : April 16, 2019
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Sponsor:
Axsome Therapeutics, Inc.
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | June 20, 2018 | ||||
First Posted Date ICMJE | July 23, 2018 | ||||
Last Update Posted Date | April 16, 2019 | ||||
Actual Study Start Date ICMJE | May 30, 2018 | ||||
Actual Primary Completion Date | January 7, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Safety outcomes: types and rates of adverse events; discontinuations due to adverse events. [ Time Frame: 6 weeks ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Assessing Symptomatic Clinical Episodes in Depression | ||||
Official Title ICMJE | A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder | ||||
Brief Summary | Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD. | ||||
Detailed Description | This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Major Depressive Disorder | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
97 | ||||
Original Estimated Enrollment ICMJE |
74 | ||||
Actual Study Completion Date ICMJE | January 7, 2019 | ||||
Actual Primary Completion Date | January 7, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (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 | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03595579 | ||||
Other Study ID Numbers ICMJE | AXS-05-MDD-201 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Axsome Therapeutics, Inc. | ||||
Study Sponsor ICMJE | Axsome Therapeutics, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Axsome Therapeutics, Inc. | ||||
Verification Date | April 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |