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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at multiple timepoints post dose on days 1, 8 and 15

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

Headache

Diarrhea

Diarrhoea

Nausea

COVID-19

Urinary tract infection

Asthenia

Memory impairment

Fatigue

Anxiety

Myalgia

Dry mouth

Abdominal pain

Hypoaesthesia

Muscle twitching

Rash

Tremor

Vaginal haemorrhage

Oedema peripheral

Hypertension

Blood triglycerides increased

Activated partial thromboplastin time prolonged

Back pain

Abdominal pain upper

Perinatal depression

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

SAGE-217 50 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 1Eligibility criteria met