A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia

• Sponsor: Sage Therapeutics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03771664
• Collaborator: (none)
• Enrollment: 87
• Locations: 28
• Arms: 2
• Actual Duration (Months): 10.9
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult subjects with comorbid major depressive disorder and insomnia

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia
• Actual Study Start Date: Feb 20, 2019
• Actual Primary Completion Date: Dec 20, 2019
• Actual Study Completion Date: Jan 17, 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. Change from baseline in sleep efficiency (SE) as assessed by polysomnography (PSG) [14 Days]

Secondary Outcome Measures

1. Change from baseline of wake after sleep onset (WASO). [14 Days]

2. Change from baseline in total sleep time (TST). [14 Days]

3. Change from baseline in Latency to Persistent Sleep (LPS) [14 Days]

4. Change from baseline in Number of Awakenings (NAW). [14 Days]

5. Change from baseline in Insomnia Severity Index (ISI) [14 Days]

6. Change from baseline in Consensus Sleep Diary - Core (CSD-C) [14 Days]

7. Change from baseline in Clinical Global Impression - Severity (CGI-S). [28 Days]

8. Change from baseline in the Clinical Global Impression - Improvement (CGI-I). [28 Days]

9. Change from baseline in the 17-item HAM-D total score. [14 Days]

10. Change from baseline in the 9-item subject-rated Patient Health Questionnaire (PHQ). [14 Days]

11. Incidence and severity of adverse events/serious adverse events. [28 Days]

12. Change from baseline in rapid eye movement (REM) and non-REM sleep. [14 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 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 a diagnosis of Insomnia that is confirmed at screening based on the DSM-5 diagnostic criteria using the SCID-5-CT.

3. Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia).

4. Subject has a MADRS score of ≥28 prior to dosingand a HAM-D total score of ≥20.

Exclusion Criteria:

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

2. Subject had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the subject has presented for screening during the 6-month postpartum period.

3. Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

4. Subject has a medical history of seizures.

5. Subject has active psychosis per Investigator assessment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sage Investigational Site	Little Rock	Arkansas	United States	72211
2	Sage Investigational Site	Rogers	Arkansas	United States	72758
3	Sage Investigational Site	Garden Grove	California	United States	92845
4	Sage Investigational Site	Oceanside	California	United States	92056
5	Sage Investigational Site	San Diego	California	United States	92103
6	Sage Investigational Site	Temecula	California	United States	92591
7	Sage Investigational Site	Fort Myers	Florida	United States	33912
8	Sage Investigational Site	Hollywood	Florida	United States	33024
9	Sage Investigational Site	Miami Lakes	Florida	United States	33016
10	Sage Investigational Site	North Miami	Florida	United States	33161
11	Sage Investigational Site	Atlanta	Georgia	United States	30331
12	Sage Investigational Site	Atlanta	Georgia	United States	30342
13	Sage Investigational Site	Decatur	Georgia	United States	30030
14	Sage Investigational Site	Chicago	Illinois	United States	60634
15	Sage Investigational Site	Lake Charles	Louisiana	United States	70629
16	Sage Investigational Site	Flowood	Mississippi	United States	39232
17	Sage Investigational Site	Saint Louis	Missouri	United States	63141
18	Sage Investigational Site	Las Vegas	Nevada	United States	89102
19	Sage Investigational Site	Berlin	New Jersey	United States	08009
20	Sage Investigational Site	Albuquerque	New Mexico	United States	87109
21	Sage Investigational Site	Brooklyn	New York	United States	11235
22	Sage Investigational Site	New York	New York	United States	10019
23	Sage Investigational Site	Cincinnati	Ohio	United States	45212
24	Sage Investigational Site	Dayton	Ohio	United States	45417
25	Sage Investigational Site	Oklahoma City	Oklahoma	United States	73103
26	Sage Investigational Site	Salem	Oregon	United States	97301
27	Sage Investigational Site	Charleston	South Carolina	United States	29407
28	Sage Investigational Site	Austin	Texas	United States	78754

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: NCT03771664
• Other Study ID Numbers: 217-MDD-304
• First Posted: Dec 11, 2018
• Last Update Posted: Jan 25, 2022
• Last Verified: Jan 1, 2022

• 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: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

No Results Posted as of Jan 25, 2022