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GABA receptor modulator

SAGE-217 for Depression

Phase 3
Waitlist Available
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new drug, SAGE-217, for people with major depressive disorder.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence and severity of adverse events.
Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence of clinically significant changes from baseline in clinical laboratory measures.
Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence of clinically significant changes from baseline in electrocardiograms (ECGs).
+2 more
Secondary outcome measures
The need for re-treatment with SAGE-217 as assessed by the number of participants achieving the requirements for re-treatment.
The need for re-treatment with SAGE-217 as assessed by the number of re-treatment cycles for each participant.
The need for re-treatment with SAGE-217 as assessed by the time to first re-treatment.
+5 more

Side effects data

From 2022 Phase 3 trial • 200 Patients • NCT04442503
27%
Somnolence
13%
Dizziness
11%
Sedation
9%
Headache
6%
Diarrhea
6%
Diarrhoea
5%
Nausea
5%
Urinary tract infection
5%
COVID-19
4%
Asthenia
3%
Memory impairment
3%
Fatigue
3%
Anxiety
3%
Myalgia
2%
Tremor
2%
Hypoaesthesia
2%
Abdominal pain
2%
Muscle twitching
2%
Vaginal haemorrhage
2%
Rash
2%
Dry mouth
1%
Oedema peripheral
1%
Hypertension
1%
Activated partial thromboplastin time prolonged
1%
Back pain
1%
Blood triglycerides increased
1%
Abdominal pain upper
1%
Perinatal depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SAGE-217 50 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: SAGE-217Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAGE-217
2017
Completed Phase 3
~3510

Find a Location

Who is running the clinical trial?

Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
10,218 Total Patients Enrolled
18 Trials studying Depression
2,662 Patients Enrolled for Depression
BiogenIndustry Sponsor
639 Previous Clinical Trials
465,893 Total Patients Enrolled
10 Trials studying Depression
2,353 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are signing up to take part in this medical research?

"Unfortunately, this study is not looking for any more participants at the moment. It was first posted on February 27th, 2019 and was last edited on July 22nd, 2022. However, there are other trials you may be eligible for - right now, there are 1354 trials involving patients with depression and 1 trial for SAGE-217 that is actively recruiting participants."

Answered by AI

If I am willing, am I able to take part in this experiment?

"Eligible patients for this research must be suffering from depression and between the ages of 18 to 75. So far, 1543 individuals have qualified."

Answered by AI

What is the latest government ruling on SAGE-217?

"SAGE-217 falls into Phase 3 of clinical trials, which is why our team at Power rated its safety a 3. There is some efficacy data as well as multiple rounds of safety data that support this classification."

Answered by AI

What other medicinal research has been done with SAGE-217?

"SAGE-217 was first studied in 2019 by Sage. So far, 10 clinical trials have completed and 1 is ongoing. The majority of these trials are taking place at Towson, Maryland."

Answered by AI

Could you tell me the age requirements for this research project?

"The age range for patients that are eligible for this particular clinical trial is between 18 and 75 years old."

Answered by AI

Is this research program open to new participants?

"No, this study is no longer recruiting patients, as is stated on clinicaltrials.gov. This study was initially posted on February 27th, 2019 but was last edited on July 22nd, 2020. Even though this study is not looking for any more participants, there are 1,355 other trials that are."

Answered by AI

Has this medical trial been attempted before?

"SAGE-217 has been under investigation since 2019 when the first trial, sponsored by Sage Therapeutics, was conducted. Recently, in 2019, SAGE-217 completed Phase 3 drug approval. Currently, there is only one active study, sponsored by Sage Therapeutics."

Answered by AI

Who else is applying?

What state do they live in?
California
Pennsylvania
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Sage Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+

Why did patients apply to this trial?

Tried two treatments. NoTried two treatments. I want to get out of bed and stop flaking on plans.
PatientReceived 1 prior treatment
I would love to help find a cure for incurable depression. So tired of living like this. I still have a few years left and I want to enjoy them.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
2019. "A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03864614.
~254 spots leftby Apr 2025
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