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New therapy targets sleep and daily rhythms to fight teen suicide

NCT ID NCT05317481

Symptom relief Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a behavioral therapy called BE-SMART-DR in 65 teens and young adults with bipolar disorder or major depression who had suicidal thoughts or past attempts. The therapy teaches self-directed strategies to regularize sleep and other daily rhythms to reduce short-term suicide risk. Participants were compared to a control group receiving general health education.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BE-SMART-DR therapy (behavioral intervention to regularize sleep and daily rhythms)
What this could lead to
If it works, this could offer a non-drug, self-directed strategy to lower suicide risk in young people with mood disorders.
What could go wrong
This is a small, completed study with 65 participants, so results may not apply to everyone. The therapy requires ongoing use and may not work for all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

65 people

The number who actually took part.

Started

Apr 2022

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 29 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * with Diagnostic and Statistical Manual 5 (DSM5) Bipolar Disorder (BD) I, II or Otherwise Specified (OS) or Major Depressive Disorder (MDD) * have a history of 1 or more suicide attempts and/or a score of at least 3 on the SSI Exclusion Criteria: * Significant medical or neurologic illness (especially if related to cerebral tissue) * MRI contraindication, * pregnancy by urine test * current moderate or severe alcohol/other substance use disorders except caffeine/nicotine * positive urine screen for benzodiazepines, cocaine, amphetamines, phencyclidine, opiates, oxycodone; not cannabis as its use is common in this population and it can remain positive for a month * current evidence-based individual psychotherapy (e.g. cognitive behavioral therapy, dialectical behavioral therapy,) or treatment directly targeting brain regions of interest (e.g. transcranial magnetic stimulation or electro-convulsive therapy), * current psychosis * inability to provide informed consent, including IQ\<70, Young Mania Rating Scale (YMRS) \>25, or too symptomatic by PI's judgment * active suicidal plan or intent or Columbia Suicide Severity Rating Scale (C-SSRS) stage "4" risk (some intent to carry out the plan; as indicated by multisite study assessing suicide risk in randomized clinical trials or if revealed on any rating scale or in judgment of any study clinician. * homicidal ideation

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Conditions

The condition(s) this trial relates to.

bipolar disorder major depressive disorder mood disorder Suicidal Ideation Suicide

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder Major depressive disorder Mood disorders Suicidal ideation Suicide

Contacts and locations

Locations

  • Magnetic Resonance Research Center

    New Haven, Connecticut, 06510, United States

  • Mood Disorders Research Program

    New Haven, Connecticut, 06510, United States

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