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Behavioral Intervention

Sleep Intervention for Teen Depression

N/A
Recruiting
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
Current use of medications or herbs with known effects on sleep
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test if improving the relationship between sleep patterns and waking time can help improve depression outcomes in teenagers with depression and disrupted sleep patterns. The trial will use a sleep intervention to target this issue

Who is the study for?
This trial is for adolescents with depression and misaligned sleep patterns, who are stable in their medical/psychiatric condition and not on medications or herbs affecting sleep. Those with active psychosis, bipolar disorder, drug dependence, or severe conditions like terminal cancer cannot join.
What is being tested?
The study tests if aligning biological circadian timing with wake time using a cognitive-behavioral sleep intervention can improve depression in adolescents. It's a confirmatory efficacy trial focused on this novel treatment target.
What are the potential side effects?
Since the interventions include TranS-C (a type of therapy) and psychoeducation (learning about mental health), side effects may be minimal but could include discomfort from discussing personal issues or changes in mood/sleep patterns.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking medication or herbs that affect my sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Children's Depression Rating Scale (CDRS-R)
Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )

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
Active Control
Group I: TranS-CExperimental Treatment1 Intervention
Group II: PsychoeducationActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TranS-C
2021
N/A
~200

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,474 Previous Clinical Trials
17,501,740 Total Patients Enrolled
3 Trials studying Delayed Sleep Phase Syndrome
125 Patients Enrolled for Delayed Sleep Phase Syndrome
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,900,976 Total Patients Enrolled
1 Trials studying Delayed Sleep Phase Syndrome
60 Patients Enrolled for Delayed Sleep Phase Syndrome
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,972 Total Patients Enrolled
~133 spots leftby Aug 2028