A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode

NCT03692910 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 217-BPD-201
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 11

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.

Conditions

Bipolar Disorder I; Bipolar Disorder II; Major Depressive Episode

Outcome Measures

Primary Outcomes (5)

• Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE was defined as an adverse event with onset after the start of study through Day 42/early termination.

  From first dose of study drug up to Day 42

• Part A: Number of Participants With TEAEs, Graded by Severity

  An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE was defined as an adverse event with onset after the start of study through Day 42/early termination. Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities).

  From first dose of study drug up to Day 42

• Part A: Percentages of Participants With Response to Suicidal Ideation and Suicidal Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

  Suicidality was monitored using the C-SSRS. This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicidal ideation and behavior, and a post-baseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), completed suicide). Percentage of participants with response 'yes' are reported for both suicidal ideation and behavior.

  Baseline, Post-baseline (any time up to Day 42)

• Part A: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score

  Manic symptoms were assessed during the study using the YMRS. The clinician-administered scale is based on 11 items of core symptoms of mania. Four of the items (irritability, speech, thought content, and disruptive/aggressive behavior) were graded on a scale of 0 to 8 (choices given as even numbers), with the remaining 7 items graded on a scale of 0 to 4. Scoring between the points given (whole or half points) is possible. The YMRS total score ranges from 0 (no symptoms) to 60 (extreme severity of symptoms). A higher total score indicates a greater degree of mania. A negative change indicates better state of health.

  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)

• Part B: Change From Baseline in the 17-Item Hamilton Depression Rating Scale (HAM-D) Total Score

  The 17-item HAM-D was used to rate the severity of depression in participants who were identified as experiencing a major depressive episode (MDE). Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items scored in a range of 0 to 4 include: agitation, depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), anxiety (psychic and somatic), hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores, with a range of 0 (not at all depressed) to 52 (severely depressed). Higher scores indicated more depression. A negative change from baseline indicates improvement.

  Baseline up to Day 42

Secondary Outcomes (18)

• Part A: Change From Baseline in the 17-Item HAM-D Total Score at Day 15

  Baseline, Day 15

• Part A: Percentage of Participants With HAM-D Response at Day 15

  Day 15

• Part A: Percentage of Participants With HAM-D Remission at Day 15

  Day 15

• Part A: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15

  Baseline, Day 15

• Part A: Change From Baseline in Response to the Clinical Global Impression - Severity (CGI-S) at Day 15

  Baseline, Day 15

Study Arms (3)

Part A (Open-label): SAGE-217

EXPERIMENTAL

Participants self-administered SAGE-217, 30 milligrams (mg), oral capsule, once daily (QD), in the evening, from Day 1 to Day 14.

Drug: SAGE-217

Part B (Double-blind): SAGE-217

EXPERIMENTAL

Participants were to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14 in Part B of the study. However, as per the Sponsor's decision, the Part B of the study was not conducted.

Drug: SAGE-217

Part B (Double-blind): Placebo

PLACEBO COMPARATOR

Participants were to receive SAGE-217 matching placebo capsule, orally, QD, in the evening, from Day 1 to Day 14 in Part B of the study. However, as per the Sponsor's decision, the Part B of the study was not conducted.

Drug: Placebo

Interventions

SAGE-217 DRUG

SAGE-217 capsule

Part A (Open-label): SAGE-217; Part B (Double-blind): SAGE-217

Placebo DRUG

SAGE-217 matching placebo capsule

Part B (Double-blind): Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Biogen: lead

Study Sites (11)

Sage Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Sage Investigational Site

Garden Grove, California, 92845, United States

Location

Sage Investigational Site

Lemon Grove, California, 91945, United States

Location

Sage Investigational Site

Orange, California, 92868, United States

Location

Sage Investigational Site

Jacksonville, Florida, 32256, United States

Location

Sage Investigational Site

Lauderhill, Florida, 33319, United States

Location

Sage Investigational Site

Orlando, Florida, 32801, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

St Louis, Missouri, 63141, United States

Location

Sage Investigational Site

Austin, Texas, 78754, United States

Location

Sage Investigational Site

Richardson, Texas, 75080, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Bipolar Disorder

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

Post review of Part A data, the study was stopped and, therefore, Part B was not conducted. Data was not collected or analyzed for any outcome measure planned for Part B.

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 2, 2018
• Study Start: August 23, 2018
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2019
• Last Updated: December 13, 2023
• Results First Posted: April 20, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (11)