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A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Subjects With Major Depressive Disorder

Sponsor
Sage Therapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT04007367
Collaborator
(none)
52
Enrollment
46
Locations
2
Arms
4.5
Actual Duration (Months)
1.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study with an open-label (OL) phase followed by a randomized, double-blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder
Actual Study Start Date :
Aug 21, 2019
Actual Primary Completion Date :
Jan 6, 2020
Actual Study Completion Date :
Jan 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: SAGE-217

Drug: SAGE-217
SAGE-217
Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Time to relapse during the Double-Blind (DB) Phase (days; from first dose of study drug in the DB Phase to relapse [date] during the DB Phase). [Up to 275 Days]

Secondary Outcome Measures

  1. Percentage of subjects who relapse during the DB Phase. [Up to 275 Days]

  2. Change from baseline in the 17-item HAM-D total score at the end of each 14-day treatment period in the DB Phase. [Up to 233 Days]

  3. HAM-D response at the end of each 14-day treatment period in the DB Phase, defined as a ≥50% reduction in HAM-D score from baseline. [Up to 233 Days]

  4. HAM-D remission at the end of each 14-day treatment period in the DB Phase, defined as HAM-D total score ≤7. [Up to 233 Days]

  5. CGI-I response, defined as "much improved" or "very much improved", at the end of each 14-day treatment period in the DB Phase. [Up to 233 Days]

  6. Change from baseline in Clinical Global Impression - Severity (CGI-S) score at the end of each 14-day treatment period in the DB Phase. [Up to 233 Days]

  7. Change from baseline in 9-item Patient Health Questionnaire (PHQ-9) score at the end of each 14-day treatment period in the DB Phase. [Up to 233 Days]

  8. Time to relapse during the DB phase (days; from first dose of study drug in DB Phase to relapse [date] during the DB Phase) for subjects who achieved HAM-D remission in the OL Phase. [Up to 275 Days]

  9. Incidence of treatment-emergent adverse events (TEAEs). [Up to 331 Days]

Eligibility Criteria

Criteria

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

  1. Subject has a diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been present for at least a 4-week period.

  2. Subject has had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).

  3. Subject is willing to delay start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.

Exclusion Criteria:

  1. Subject has attempted suicide associated with the current episode of MDD

  2. Subject has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) will be used for this purpose.

  3. Subject has a positive pregnancy test at screening or on Day 1 prior to dosing.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sage Investigational Site Bentonville Arkansas United States 72712
2 Sage Investigational Site Bellflower California United States 90706
3 Sage Investigational Site Garden Grove California United States 92845-2506
4 Sage Investigational Site Lemon Grove California United States 91945
5 Sage Investigational Site Oceanside California United States 92056-4500
6 Sage Investigational Site Orange California United States 92868-2847
7 Sage Investigational Site Riverside California United States 92503
8 Sage Investigational Site San Diego California United States 92103
9 Sage Investigational Site San Marcos California United States 92078
10 Sage Investigational Site Sherman Oaks California United States 91403-2131
11 Sage Investigational Site Coral Springs Florida United States 33067-4644
12 Sage Investigational Site Jacksonville Florida United States 32256
13 Sage Investigational Site Lauderhill Florida United States 33319
14 Sage Investigational Site Orlando Florida United States 32801
15 Sage Investigational Site Alpharetta Georgia United States 30022
16 Sage Investigational Site Atlanta Georgia United States 30328
17 Sage Investigational Site Atlanta Georgia United States 30329
18 Sage Investigational Site Atlanta Georgia United States 30331
19 Sage Investigational Site Decatur Georgia United States 30030
20 Sage Investigational Site Chicago Illinois United States 60634
21 Sage Investigational Site Lincolnwood Illinois United States 60712
22 Sage Investigational Site Lake Charles Louisiana United States 70629
23 Sage Investigational Site Gaithersburg Maryland United States 20877
24 Sage Investigational Site Boston Massachusetts United States 02131
25 Sage Investigational Site Methuen Massachusetts United States 01844
26 Sage Investigational Site Watertown Massachusetts United States 02472-4153
27 Sage Investigational Site Ann Arbor Michigan United States 48109-2700
28 Sage Investigational Site Las Vegas Nevada United States 89102
29 Sage Investigational Site Berlin New Jersey United States 08009
30 Sage Investigational Site Cherry Hill New Jersey United States 08002-3008
31 Sage Investigational Site Marlton New Jersey United States 08053
32 Sage Investigational Site Albuquerque New Mexico United States 87109
33 Sage Investigational Site Jamaica New York United States 11432
34 Sage Investigational Site New York New York United States 10017
35 Sage Investigational Site New York New York United States 10128
36 Sage Investigational Site Rochester New York United States 14618-1609
37 Sage Investigational Site Dayton Ohio United States 454117
38 Sage Investigational Site North Canton Ohio United States 44720
39 Sage Investigational Site Oklahoma City Oklahoma United States 73106
40 Sage Investigational Site Allentown Pennsylvania United States 18104-5051
41 Sage Investigational Site Memphis Tennessee United States 38119
42 Sage Investigational Site Austin Texas United States 78737
43 Sage Investigational Site Dallas Texas United States 75231-3442
44 Sage Investigational Site Richardson Texas United States 75080
45 Sage Investigational Site Wichita Falls Texas United States 76309
46 Sage Investigational Site Everett Washington United States 98201

Sponsors and Collaborators

  • Sage Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sage Therapeutics
ClinicalTrials.gov Identifier:
NCT04007367
Other Study ID Numbers:
  • 217-MDD-302
First Posted:
Jul 5, 2019
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 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
Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major

Study Results

No Results Posted as of Oct 20, 2021