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Other

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

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Plasma Concentrations of SAGE-217
Secondary study objectives
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%
COVID-19
5%
Urinary tract infection
4%
Asthenia
3%
Memory impairment
3%
Fatigue
3%
Anxiety
3%
Myalgia
2%
Dry mouth
2%
Abdominal pain
2%
Hypoaesthesia
2%
Muscle twitching
2%
Rash
2%
Tremor
2%
Vaginal haemorrhage
1%
Oedema peripheral
1%
Hypertension
1%
Blood triglycerides increased
1%
Activated partial thromboplastin time prolonged
1%
Back pain
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
~3480

Find a Location

Who is running the clinical trial?

BiogenIndustry Sponsor
642 Previous Clinical Trials
467,161 Total Patients Enrolled
10 Trials studying Depression
3,832 Patients Enrolled for Depression
Sage TherapeuticsLead Sponsor
50 Previous Clinical Trials
11,097 Total Patients Enrolled
18 Trials studying Depression
4,141 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
~15 spots leftby Sep 2025
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