GEMINI: A Trial of AXS-05 in Patients With Major Depressive Disorder

• Sponsor: Axsome Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04019704
• Collaborator: (none)
• Enrollment: 327
• Locations: 43
• Arms: 2
• Actual Duration (Months): 5.5
• Patients Per Site: 7.6
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Condition or Disease	Intervention/Treatment	Phase
Depression; Major Depressive Disorder	Drug: AXS-05; Drug: Placebo	Phase 3

Detailed Description

This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 327 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
• Actual Study Start Date: Jun 20, 2019
• Actual Primary Completion Date: Nov 26, 2019
• Actual Study Completion Date: Dec 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXS-05 AXS-05 (bupropion and dextromethorphan) oral tablets	Drug: AXS-05; Oral AXS-05 tablets, taken daily for 6 weeks.
Placebo Comparator: Placebo Placebo oral tablets to match AXS-05	Drug: Placebo; Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

Outcome Measures

Primary Outcome Measures

1. Change in MADRS total score from baseline to Week 6 [6 weeks]

   The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Secondary Outcome Measures

1. Change in MADRS total score from baseline to Week 2 [2 weeks]

2. Percentage of subjects achieving remission (MADRS total score of ≤ 10) at Week 2 [2 weeks]

3. Change in MADRS total score from baseline to Week 1 [1 week]

4. Percentage of responders (≥50% reduction in MADRS total score) at Week 6 [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Age 18 - 65

• Currently meets DSM-5 criteria for MDD

• Body Mass Index between 18 and 40 kg/m^2, inclusive

Key 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Site	Phoenix	Arizona	United States	85012
2	Clinical Research Site	Phoenix	Arizona	United States	85016
3	Clinical Research Site	Little Rock	Arkansas	United States	72209
4	Clinical Research Site	Bellflower	California	United States	90706
5	Clinical Research Site	Beverly Hills	California	United States	90210
6	Clinical Research Site	Garden Grove	California	United States	92845
7	Clinical Research Site	Oakland	California	United States	94607
8	Clinical Research Site	Oceanside	California	United States	92056
9	Clinical Research Site	Panorama City	California	United States	91402
10	Clinical Research Site	Redlands	California	United States	92374
11	Clinical Research Site	Riverside	California	United States	92506
12	Clinical Research Site	San Diego	California	United States	92103
13	Clinical Research Site	Sherman Oaks	California	United States	91403
14	Clinical Research Site	Upland	California	United States	91786
15	Clinical Research Site	Coral Springs	Florida	United States	33067
16	Clinical Research Site	Hollywood	Florida	United States	33024
17	Clinical Research Site	Jacksonville	Florida	United States	32256
18	Clinical Research Site	Lauderhill	Florida	United States	33319
19	Clinical Research Site	North Miami	Florida	United States	33161
20	Clinical Research Site	Orlando	Florida	United States	32801
21	Clinical Research Site	Atlanta	Georgia	United States	30328
22	Clinical Research Site	Boise	Idaho	United States	83704
23	Clinical Research Site	Chicago	Illinois	United States	60634
24	Clinical Research Site	Boston	Massachusetts	United States	02131
25	Clinical Research Site	Las Vegas	Nevada	United States	89102
26	Clinical Research Site	Berlin	New Jersey	United States	08009
27	Clinical Research Site	Cherry Hill	New Jersey	United States	08002
28	Clinical Research Site	Toms River	New Jersey	United States	08755
29	Clinical Research Site	Jamaica	New York	United States	11432
30	Clinical Research Site	Rochester	New York	United States	14618
31	Clinical Research Site	Staten Island	New York	United States	10312
32	Clinical Research Site	Hickory	North Carolina	United States	28601
33	Clinical Research Site	Cincinnati	Ohio	United States	45219
34	Clinical Research Site	Middleburg Heights	Ohio	United States	44130
35	Clinical Research Site	Oklahoma City	Oklahoma	United States	73112
36	Clinical Research Site	Media	Pennsylvania	United States	19063
37	Clinical Research Site	Philadelphia	Pennsylvania	United States	19104
38	Clinical Research Site	Memphis	Tennessee	United States	38119
39	Clinical Research Site	Dallas	Texas	United States	75243
40	Clinical Research Site	Fort Worth	Texas	United States	76104
41	Clinical Research Site	Houston	Texas	United States	77058
42	Clinical Research Site	Wichita Falls	Texas	United States	76309
43	Clinical Research Site	Everett	Washington	United States	98201

Sponsors and Collaborators

• Axsome Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Axsome Therapeutics Website

Publications

None provided.

• Responsible Party: Axsome Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04019704
• Other Study ID Numbers: AXS-05-MDD-301
• First Posted: Jul 15, 2019
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Axsome Therapeutics, Inc.: Depressive Disorder; Depressive Disorder, Major; Bupropion; Dextromethorphan; MDD; Dopamine Reuptake Inhibitor; AXS-05; NMDA Receptor Antagonist; Central Nervous System; CNS; Sigma-1 Receptor Agonist; Nicotinic Acetylcholine Receptor Antagonist; Norepinephrine Reuptake Inhibitor; Glutamate Modulator; Axsome Therapeutics; GEMINI; Serotonin Reuptake Inhibitor
• Additional relevant MeSH terms: Disease; Depression; Depressive Disorder; Depressive Disorder, Major

Study Results

No Results Posted as of Sep 28, 2021