A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder

Sponsor

Sage Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03672175

Collaborator

(none)

581

Enrollment

Locations

Arms

15.3

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult subjects with major depressive disorder

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: SAGE-217 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

581 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder

Actual Study Start Date :

Dec 7, 2018

Actual Primary Completion Date :

Sep 24, 2019

Actual Study Completion Date :

Mar 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAGE-217 (low dose)	Drug: SAGE-217 Sage-217
Experimental: SAGE-217 (high dose)	Drug: SAGE-217 Sage-217
Placebo Comparator: Placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: SAGE-217 (low dose)

Drug: SAGE-217

Sage-217

Experimental: SAGE-217 (high dose)

Drug: SAGE-217

Sage-217

Placebo Comparator: Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score. [15 Days]

Secondary Outcome Measures

Change from baseline in the 17-item HAM-D total score at other timepoints. [Up to 182 Days]
Change from baseline in the Clinical Global Impression - Improvement (CGI-I) response, defined as "much improved" or "very much improved". [Up to 182 Days]
Change from baseline in Clinical Global Impression - Severity (CGI-S) score. [Up to 182 Days]
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score. [42 Days]
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS). [42 Days]
Incidence and severity of adverse events/serious adverse events. [Up to 182 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject has a diagnosis of MDD with symptoms that have been present for at least a 4-week period.
Subject has a MADRS total score of ≥32 and a HAM-D total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion Criteria:

Subject has active psychosis.
Subject has attempted suicide associated with the current episode of MDD.
Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sage Investigational Site	Rogers	Arkansas	United States	72758
2	Sage Investigational Site	Bellflower	California	United States	90706
3	Sage Investigational Site	Garden Grove	California	United States	92845
4	Sage Investigational Site	Glendale	California	United States	91206
5	Sage Investigational Site	National City	California	United States	91950
6	Sage Investigational Site	Oakland	California	United States	94607
7	Sage Investigational Site	Oceanside	California	United States	92054
8	Sage Investigational Site	Orange	California	United States	92868
9	Sage Investigational Site	Pico Rivera	California	United States	90660
10	Sage Investigational Site	Redlands	California	United States	92374
11	Sage Investigational Site	San Diego	California	United States	92103
12	Sage Investigational Site	Sherman Oaks	California	United States	91403
13	Sage Investigational Site	Temecula	California	United States	92591
14	Sage Investigational Site	Coral Springs	Florida	United States	33067
15	Sage Investigational Site	Hollywood	Florida	United States	33024
16	Sage Investigational Site	Jacksonville	Florida	United States	32256
17	Sage Investigational Site	Lauderhill	Florida	United States	33319
18	Sage Investigational Site	Maitland	Florida	United States	32750
19	Sage Investigational Site	North Miami	Florida	United States	33161
20	Sage Investigational Site	Orange City	Florida	United States	32763
21	Sage Investigational Site	Orlando	Florida	United States	32801
22	Sage Investigational Site	Orlando	Florida	United States	32807
23	Sage Investigational Site	Atlanta	Georgia	United States	30328
24	Sage Investigational Site	Atlanta	Georgia	United States	30331
25	Sage Investigational Site	Atlanta	Georgia	United States	30341
26	Site Investigational Site	Decatur	Georgia	United States	30030
27	Sage Investigational Site	Skokie	Illinois	United States	60076
28	Sage Investigational Site	Pikesville	Maryland	United States	21208
29	Sage Investigational Site	Flowood	Mississippi	United States	39110
30	Sage Investigational Site	Flowood	Mississippi	United States	39232
31	Sage Investigational Site	O'Fallon	Missouri	United States	63368
32	Sage Investigational Site	Saint Louis	Missouri	United States	63141
33	Sage Investigational Site	Las Vegas	Nevada	United States	89102
34	Sage Investigational Site	Berlin	New Jersey	United States	08009
35	Sage Investigational Site	Jamaica	New York	United States	11432
36	Sage Investigational Site	Rochester	New York	United States	14618
37	Sage Investigational Site	Charlotte	North Carolina	United States	28211
38	Sage Investigational Site	Cincinnati	Ohio	United States	45215
39	Sage Investigational Site	Dayton	Ohio	United States	45417
40	Sage Investigational Site	North Canton	Ohio	United States	44720
41	Sage Investigational Site	Oklahoma City	Oklahoma	United States	73106
42	Sage Investigational Site	Oklahoma City	Oklahoma	United States	73112
43	Sage Investigational Site	Portland	Oregon	United States	97210
44	Sage Investigational Site	Portland	Oregon	United States	97214
45	Sage Investigational Site	Allentown	Pennsylvania	United States	18104
46	Sage Investigational Site	Charleston	South Carolina	United States	29407
47	Sage Investigational Site	Memphis	Tennessee	United States	38119
48	Sage Investigational Site	Austin	Texas	United States	78754
49	Sage Investigational Site	Bellaire	Texas	United States	77401
50	Sage Investigational Site	DeSoto	Texas	United States	75115
51	Sage Investigational Site	Richardson	Texas	United States	75080
52	Sage Investigational Site	Wichita Falls	Texas	United States	76309
53	Sage Investigational Site	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

Sage Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Sage Therapeutics

ClinicalTrials.gov Identifier:

NCT03672175

Other Study ID Numbers:

217-MDD-301

First Posted:

Sep 14, 2018

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Study Results

No Results Posted as of Jan 24, 2022