Phase 2
N=35
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
Bipolar Disorder I · Bipolar Disorder II · Major Depressive Episode
Bottom Line
View on ClinicalTrials.gov: NCT03692910 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAGE-217 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) |
16 | — |
| PRIMARY Part A: Number of Participants With TEAEs, Graded by Severity |
11; 5; 0 | — |
| PRIMARY Part A: Percentages of Participants With Response to Suicidal Ideation and Suicidal Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) |
22.9; 9.4; 0; 0 | — |
| PRIMARY Part A: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score |
4.9; -0.9; -0.9; -0.7; 0.3; -0.7 | — |
| PRIMARY Part B: Change From Baseline in the 17-Item Hamilton Depression Rating Scale (HAM-D) Total Score |
— | — |
| SECONDARY Part A: Change From Baseline in the 17-Item HAM-D Total Score at Day 15 |
25.7; -11.4 | — |
| SECONDARY Part A: Percentage of Participants With HAM-D Response at Day 15 |
43.5 | — |
| SECONDARY Part A: Percentage of Participants With HAM-D Remission at Day 15 |
30.4 | — |
| SECONDARY Part A: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 |
34.4; -15.5 | — |
| SECONDARY Part A: Change From Baseline in Response to the Clinical Global Impression - Severity (CGI-S) at Day 15 |
4.4; -1.4 | — |
| SECONDARY Part A: Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) at Day 15 |
47.8 | — |
| SECONDARY Part A: Insomnia Severity Index (ISI) at Day 15 |
13.1 | — |
| SECONDARY Part B: Change From Baseline in the Total HAM-D Score at Day 15 |
— | — |
| SECONDARY Part B: Percentage of Participants With HAM-D Response at Day 15 |
— | — |
| SECONDARY Part B: Percentage of Participants With HAM-D Remission at Day 15 |
— | — |
| SECONDARY Part B: Change From Baseline in the MADRS Total Score at Day 15 |
— | — |
| SECONDARY Part B: Change From Baseline in Response to the Clinical Global Impression - Severity (CGI-S) at Day 15 |
— | — |
| SECONDARY Part B: Number of Participants With Response to Clinical Global Impression - Improvement (CGI-I) at Day 15 |
— | — |
| SECONDARY Part B: Number of Participants With At Least One Treatment-Emergent Adverse Events (TEAEs) |
— | — |
| SECONDARY Part B: Number of Participants With TEAEs, Graded by Severity |
— | — |
| SECONDARY Part B: Percentages of Participants With Change From Baseline in Suicidal Ideation and Suicidal Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) |
— | — |
| SECONDARY Part B: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score |
— | — |
| SECONDARY Part B: Insomnia Severity Index (ISI) at Day 15 |
— | — |
Summary
This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
Eligibility Criteria
Inclusion Criteria
- Participant had a documented history of hypomanic or manic episode and a diagnosis of bipolar I or bipolar II disorder with a current major depressive episode.
Exclusion Criteria
- Participant had a history of suicide attempt.
- Participant had current suicidal ideation with plans.
- Participant had a history of rapid cycling bipolar disorder.
Data sourced from ClinicalTrials.gov (NCT03692910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.