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Behavioral Intervention

TranS-C for Delayed Sleep Phase Syndrome

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of treatment (anticipated average exposure 2 months), months 8 and 14

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Children's Depression Rating Scale (CDRS-R)

Change in phase angle difference (PAD) between DLMO and waketime (PADDLMO WAKETIME )

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,367 Total Patients Enrolled

1 Trials studying Delayed Sleep Phase Syndrome

60 Patients Enrolled for Delayed Sleep Phase Syndrome

Stanford UniversityOTHER

2,395 Previous Clinical Trials

17,341,255 Total Patients Enrolled

3 Trials studying Delayed Sleep Phase Syndrome

360 Patients Enrolled for Delayed Sleep Phase Syndrome

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,509 Total Patients Enrolled

Frequently Asked Questions

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

Is there an age restriction for potential participants in this study, particularly regarding individuals who are 55 years of age or older?

"To be eligible for this research study, potential participants must fall within the age range of 12 to 18 years. It is worth noting that there are a total of 216 trials catering specifically to individuals under the age of 18 and an additional 980 studies targeting those over the age of 65."

Answered by AI

Which specific criteria must individuals meet to be eligible for enrollment in this research study?

"To be eligible for this research study, potential participants must have delayed sleep phase syndrome and fall within the age range of 12 to 18 years old. The trial aims to recruit approximately 200 individuals with these specific criteria."

Answered by AI

What is the current number of individuals enrolled in this clinical trial?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is actively seeking eligible participants. It was initially posted on January 15th, 2024 and has been recently updated as of January 16th, 2024. The study aims to enroll a total of 200 patients at one designated site."

Answered by AI

Are researchers currently accepting participants for this study?

"Indeed, as per the information available on clinicaltrials.gov, this research study is actively seeking participants. The initial posting of the study was made on January 15th, 2024 and the most recent update occurred on January 16th, 2024. The study aims to enroll a total of 200 participants from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Better Sleep Study

Lauren Asarnow, Ph.D. 2024. "Better Sleep Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139861.

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