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Teen therapy aims to stop bipolar before it starts

NCT ID NCT04815239

Prevention Sponsor: University of Pittsburgh 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a type of talk therapy called Interpersonal and Social Rhythm Therapy (IPSRT) can prevent bipolar disorder in teenagers (ages 12-18) who have a parent with bipolar disorder and are considered high-risk. Participants receive 8 sessions of IPSRT or a healthy lifestyle program via video call, and are followed for 18 months. The goal is to see if stabilizing sleep and daily routines can reduce manic symptoms and mood swings.

What this could mean

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

Active substance
Interpersonal and Social Rhythm Therapy (IPSRT) – a behavioral therapy that helps stabilize sleep and daily routines
What this could lead to
If it works, this could point toward a way to prevent or delay bipolar disorder in teenagers who are at high genetic risk.
What could go wrong
This is a relatively small, early-stage trial. The therapy may not prevent bipolar episodes, and results may not apply to all at-risk youth.

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

119 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

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

12 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 12-18 years * A parent with a diagnosis of BP I or II * Baseline Risk Calculator score\>0.05; * Able/willing to give informed consent/assent Exclusion Criteria: * A lifetime diagnosis of BP I or II * Current unstabilized psychiatric symptoms * Evidence of developmental disorder or central nervous system disorder

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Conditions

The condition(s) this trial relates to.

bipolar disorder prevention target

As listed by the trial registrant

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

Bipolar disorder

Contacts and locations

Locations

  • Nicole Arnold

    Pittsburgh, Pennsylvania, 15213, United States

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