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Assessing Symptomatic Clinical Episodes in Depression (ASCEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03595579
Recruitment Status : Completed
First Posted : July 23, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Tracking Information
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
 (submitted: July 12, 2018)
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 Complete list of historical versions of study NCT03595579 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 12, 2018)
  • Montgomery and Asberg Depression Rating Scale (MADRS) for change in severity of symptoms. [ Time Frame: 6 weeks ]
  • Clinical Global Impression of Severity of Illness (CGI-S) for change in severity of symptoms. [ Time Frame: 6 weeks ]
  • Clinical Global Impression of Improvement of Illness (CGI-I) for change in improvement of disease state. [ Time Frame: 6 weeks ]
  • Quick Inventory of Depressive Symptomology - Self-Rated (QIDS-SR-16) for change in subject-rated depressive symptomology. [ Time Frame: 6 weeks ]
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
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: AXS-05
    AXS-05 taken daily for 6 weeks.
  • Drug: Bupropion
    Bupropion taken daily for 6 weeks.
Study Arms  ICMJE
  • Experimental: AXS-05
    Intervention: Drug: AXS-05
  • Active Comparator: Bupropion
    Intervention: Drug: Bupropion
Publications * Not Provided

*   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
 (submitted: April 15, 2019)
97
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2018)
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:

  • Currently meets DSM-5 criteria for MDD
  • Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
  • Agree to use adequate method of contraception for the duration of the study
  • Additional criteria may apply

Exclusion Criteria:

  • Suicide risk
  • History of treatment resistance in current depressive episode
  • History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Additional criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: via publication
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