Clinical trial NCT03692910: A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
Official title: A 2-Part Study (Open-label Followed by Double-blind, Randomized, Placebo-controlled, Parallel Group) of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Disorder I
Bipolar Disorder II
Major Depressive Episode
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

1. 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:

1. Participant had a history of suicide attempt.
2. Participant had current suicidal ideation with plans.
3. Participant had a history of rapid cycling bipolar disorder.

Primary outcomes:
measure: Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to Day 42
measure: Part A: Number of Participants With TEAEs, Graded by Severity
timeFrame: From first dose of study drug up to Day 42
measure: Part A: Percentages of Participants With Response to Suicidal Ideation and Suicidal Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, Post-baseline (any time up to Day 42)
measure: Part A: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score
timeFrame: Baseline, Days 3, 8, 12, 15, 21, 28, 35, and 42, Last value on treatment (up to Day 14), Last value on study (up to Day 42)
measure: Part B: Change From Baseline in the 17-Item Hamilton Depression Rating Scale (HAM-D) Total Score
timeFrame: Baseline up to Day 42
Secondary outcomes:
measure: Part A: Change From Baseline in the 17-Item HAM-D Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Part A: Percentage of Participants With HAM-D Response at Day 15
timeFrame: Day 15
measure: Part A: Percentage of Participants With HAM-D Remission at Day 15
timeFrame: Day 15
measure: Part A: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Part A: Change From Baseline in Response to the Clinical Global Impression - Severity (CGI-S) at Day 15
timeFrame: Baseline, Day 15
measure: Part A: Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) at Day 15
timeFrame: Day 15
measure: Part A: Insomnia Severity Index (ISI) at Day 15
timeFrame: Day 15
measure: Part B: Change From Baseline in the Total HAM-D Score at Day 15
timeFrame: Baseline, Day 15
measure: Part B: Percentage of Participants With HAM-D Response at Day 15
timeFrame: Day 15
measure: Part B: Percentage of Participants With HAM-D Remission at Day 15
timeFrame: Day 15
measure: Part B: Change From Baseline in the MADRS Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Part B: Change From Baseline in Response to the Clinical Global Impression - Severity (CGI-S) at Day 15
timeFrame: Baseline, Day 15
measure: Part B: Number of Participants With Response to Clinical Global Impression - Improvement (CGI-I) at Day 15
timeFrame: Day 15
measure: Part B: Number of Participants With At Least One Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to Day 42
measure: Part B: Number of Participants With TEAEs, Graded by Severity
timeFrame: From first dose of study drug up to Day 42
measure: 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)
timeFrame: Baseline up to Day 42
measure: Part B: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score
timeFrame: Baseline up to Day 42
measure: Part B: Insomnia Severity Index (ISI) at Day 15
timeFrame: Day 15
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Garden Grove
country: United States
facility: Sage Investigational Site
state: California
city: Lemon Grove
country: United States
facility: Sage Investigational Site
state: California
city: Orange
country: United States
facility: Sage Investigational Site
state: California
city: Jacksonville
country: United States
facility: Sage Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Sage Investigational Site
state: Florida
city: Orlando
country: United States
facility: Sage Investigational Site
state: Florida
city: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Saint Louis
country: United States
facility: Sage Investigational Site
state: Missouri
city: Austin
country: United States
facility: Sage Investigational Site
state: Texas
city: Richardson
country: United States
facility: Sage Investigational Site
state: Texas
Study officials:
References: