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SAGE-217 for Depression in Pediatric Patients

Phase 1
Recruiting
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has a body weight greater than or equal to 20 kg and a body mass index greater than fifth percentile and less than ninety-fifth percentile for age at Screening.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at multiple timepoints post dose on days 1, 8 and 15
Awards & highlights

Study Summary

This trial looks at how safe and effective a drug for depression is in kids and teens. #MentalHealth

Who is the study for?
This trial is for children and adolescents aged 7 to 17 with Major Depressive Disorder (MDD). They must meet specific diagnostic criteria, have a certain level of depression severity, and be within a healthy weight range. A parent or caregiver must accompany them to all visits.Check my eligibility
What is being tested?
The study is testing SAGE-217's effects on young patients with MDD. It aims to understand how the drug moves through and affects the bodies of these age groups while monitoring its safety.See study design
What are the potential side effects?
While not explicitly listed in your summary, common side effects for psychiatric medications like SAGE-217 may include nausea, headache, sleep disturbances, agitation or anxiety. Each patient's experience can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is over 20 kg and my BMI is between the 5th and 95th percentile for my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at multiple timepoints post dose on days 1, 8 and 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and at multiple timepoints post dose on days 1, 8 and 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma Concentrations of SAGE-217
Secondary outcome measures
Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)

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

2Treatment groups
Experimental Treatment
Group I: Part B: SAGE-217Experimental Treatment1 Intervention
Children (7-11 years of age) will be enrolled to receive SAGE-217 orally, during the daytime on Day 1 and in the evening on Days 2 to 14. The dose to be administered will be determined after review of safety and PK data in Part A.
Group II: Part A: SAGE-217Experimental Treatment1 Intervention
Adolescents (12-17 years of age) will be enrolled to receive SAGE-217 orally, during the daytime on Day 1 and in the evening on Days 2 to 14. Participants with a body weight greater than or equal to 54 kilograms (kg) will receive 50 mg, and participants with a body weight less than 54 kg will receive 40 mg.
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?

BiogenIndustry Sponsor
639 Previous Clinical Trials
467,400 Total Patients Enrolled
10 Trials studying Depression
3,860 Patients Enrolled for Depression
Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,725 Total Patients Enrolled
18 Trials studying Depression
4,169 Patients Enrolled for Depression

Media Library

SAGE-217 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05655507 — Phase 1
SAGE-217 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05655507 — Phase 1
Depression Research Study Groups: Part A: SAGE-217, Part B: SAGE-217
Depression Clinical Trial 2023: SAGE-217 Highlights & Side Effects. Trial Name: NCT05655507 — Phase 1
Depression Patient Testimony for trial: Trial Name: NCT05655507 — Phase 1

Frequently Asked Questions

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

Are there any unfilled vacancies in this research initiative?

"Affirmative. Clinicaltrials.gov documents that this experiment, which was initially posted on April 19th 2023, is presently looking for volunteers to participate in the trial. 36 participants need to be recruited from 5 distinct research centres."

Answered by AI

Are my credentials compatible with the criteria for enrolling in this research project?

"Eligible applicants for this clinical trial must have a diagnosis of depression and be between 7 and 17 years old. The study aims to recruit approximately 36 participants."

Answered by AI

How many participants are currently being treated in this medical trial?

"Affirmative. As confirmed on clinicaltrials.gov, this medical study is currently enrolling patients and was initially posted in April 19th 2023 before being refreshed on May 15th of the same year. 36 individuals must be recruited from 5 distinct sites for the trial to start."

Answered by AI

What is the overall scope of this trial in terms of medical centers?

"This clinical trial is now actively recruiting from 5 clinics, situated in Decatur, Flowood and Cincinnati among other areas. To minimize travel demands on participants, it is advisable to choose the clinic closest your residence."

Answered by AI

Has the Food and Drug Administration authorized Part A: SAGE-217 for general use?

"The safety of Part A: SAGE-217 has been appraised as a 1 due to it being in the first phase of trials, so there is currently limited evidence suggesting its effectiveness and safety."

Answered by AI

Is the age limit of 55+ applicable to this research trial?

"This clinical study is applicable to patients aged 7-17. Across the United States, 445 trials are available for individuals under 18 years old while 1545 trials exist for seniors above 65."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Sage Investigational Site
Other

Why did patients apply to this trial?

Hope to find some way to help me and others with major depression.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is there any study's in Ann Arbor Michigan? Or Detroit?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Sage Investigational Site: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
SAGE-217 Pharmacokinetics (PK) and Safety Study Pediatric Participants With Major Depressive Disorder (MDD)
2023. "SAGE-217 Pharmacokinetics (PK) and Safety Study Pediatric Participants With Major Depressive Disorder (MDD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05655507.
All > Mdd
~18 spots leftby Apr 2025
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