Assessing Symptomatic Clinical Episodes in Depression (ASCEND)

• ClinicalTrials.gov Identifier: NCT03595579
• Recruitment Status: Completed
• First Posted: July 23, 2018
• Last Update Posted: April 16, 2019
• Sponsor: Axsome Therapeutics, Inc.
• Information provided by (Responsible Party): Axsome Therapeutics, Inc.

Tracking Information

• First Submitted Date: June 20, 2018
• First Posted Date: July 23, 2018
• Last Update Posted Date: April 16, 2019
• Actual Study Start Date: May 30, 2018
• Actual Primary Completion Date: January 7, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: 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: Assessing Symptomatic Clinical Episodes in Depression
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• Drug: AXS-05
  AXS-05 taken daily for 6 weeks.
• Drug: Bupropion
  Bupropion taken daily for 6 weeks.

Study Arms

• Experimental: AXS-05
  Intervention: Drug: AXS-05
• Active Comparator: Bupropion
  Intervention: Drug: Bupropion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 15, 2019): 97
• Original Estimated Enrollment (submitted: July 12, 2018): 74
• Actual Study Completion Date: January 7, 2019
• Actual Primary Completion Date: January 7, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03595579
• Other Study ID Numbers: 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

• Plan to Share IPD: Yes
• Plan Description: via publication

• Responsible Party: Axsome Therapeutics, Inc.
• Study Sponsor: Axsome Therapeutics, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Axsome Therapeutics, Inc.
• Verification Date: April 2019