What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder that address sleep and circadian disruptions include melatonin, mood stabilizers, and light therapy. Melatonin is generally well-tolerated but can cause side effects such as headaches, elevated liver function tests, and abnormal dreams. Mood stabilizers like lithium and valproate can lead to side effects including tremors, increased thirst, diarrhea, and potential thyroid dysfunction. Light therapy, while beneficial for some, can cause clinical instability if not properly managed, particularly in the morning. These treatments aim to stabilize mood and improve sleep patterns, but they must be carefully monitored to manage potential side effects.

What prior FDA approvals exist?

FDA-approved treatments for Bipolar Disorder that address sleep and circadian disruptions include mood stabilizers like lithium and anticonvulsants such as lamotrigine and valproic acid. Atypical antipsychotics like olanzapine and quetiapine are also approved and can help manage mood swings and sleep disturbances. These medications work by stabilizing mood and regulating neurotransmitter activity, which can help normalize sleep patterns and circadian rhythms. While IPSRT focuses on behavioral interventions to stabilize daily routines and sleep patterns, these medications provide a pharmacological approach to achieving similar outcomes.

What other types of research exist?

Promising novel alternatives to IPSRT for Bipolar Disorder patients include triple chronotherapy, which has shown feasibility and tolerability in unipolar depression and may be explored further for bipolar disorder. Additionally, deep brain stimulation (DBS) is an investigational treatment for severe, treatment-refractory conditions and may offer benefits when combined with cognitive-behavioral therapy (CBT). Morning light therapy is another low-risk intervention that can help correct circadian rhythm disruptions and may be beneficial when combined with behavioral education.

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IPSRT + Healthy Lifestyle Intervention for Bipolar Disorder Risk (KEY Trial)

N/A

Recruiting

Led By Tina R Goldstien, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A parent with a diagnosis of BP I or II

Age 12-18 years

Must not have

Evidence of developmental disorder or central nervous system disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a telehealth therapy called IPSRT to help children at high risk of bipolar disorder due to having a bipolar parent. The therapy focuses on improving sleep and daily routines to prevent the disorder. The study will monitor outcomes over time. Interpersonal and Social Rhythm Therapy (IPSRT) was specifically developed to manage stressful life events, improve disruptions in social and circadian rhythms, and has shown efficacy in treating bipolar disorder.

Who is the study for?

This trial is for young people aged 12-18 who are at high risk of developing bipolar disorder because they have a parent with the condition. They must be able to understand and agree to the study's procedures. Those with severe psychiatric symptoms, a history of bipolar disorder, or developmental or central nervous system disorders cannot participate.

What is being tested?

The study tests Interpersonal and Social Rhythm Therapy (IPSRT) against a Healthy Lifestyle Behaviors Program (HL), both delivered via videoconference over eight sessions. The goal is to see which intervention better prevents the onset of bipolar symptoms like mania in these high-risk youths over an 18-month period.

What are the potential side effects?

Since IPSRT and HL are non-medical interventions focusing on therapy and lifestyle changes rather than drugs, side effects may include discomfort from discussing personal issues or changing daily routines but do not involve typical drug-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My parent has been diagnosed with Bipolar I or II.

Select...

I am between 12 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a developmental or brain disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Subthreshold or Threshold Manic Symptoms

Risk for Subthreshold or Threshold Manic Episodes

Severity of Affective lability

Secondary study objectives

Sleep variability (objective)

Sleep variability (subjective)

Total sleep time (Objective)

+1 more

Other study objectives

Exploratory: Association between actigraphy and passive sensing-derived measures of sleep-wake

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Interpersonal and Social Rhythm Therapy (IPSRT)Active Control1 Intervention

Interpersonal and Social Rhythm Therapy (IPSRT) for at-risk offspring includes 8 sessions over 6 months delivered via secure telemedicine platform. The basis of the intervention is the treatment manual iteratively developed and tested in close consultation with content experts during our open pilot study and R34.The intervention focuses on education about BP risk, stabilizing sleep and daily routines and interpersonal relationships.

Group II: Healthy Lifestyle Intervention (HL)Active Control1 Intervention

HL is based on the treatment manual developed in a prior trial for adults and adolescents with BP. HL includes psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health. In HL, patients are taught to develop and maintain an individualized lifestyle plan and provided support and encouragement for making progress toward their goals. HL clinicians will deliver 8 sessions over 6 months via secure telehealth platform.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Disorder often target the regulation of mood and stabilization of circadian rhythms. Interpersonal and Social Rhythm Therapy (IPSRT) specifically aims to stabilize daily routines and improve sleep patterns, which can mitigate mood swings by addressing circadian disruptions. This is crucial for Bipolar Disorder patients as irregular sleep and daily routines can exacerbate mood instability. Other treatments, such as mood stabilizers (e.g., lithium, valproate) and antipsychotics, work by modulating neurotransmitter activity to stabilize mood and prevent manic or depressive episodes. These treatments are essential for managing the chronic and episodic nature of Bipolar Disorder, helping patients maintain a more consistent and functional daily life.

Comorbid Premenstrual Dysphoric Disorder in Women with Bipolar Disorder: Management Challenges.[Treatment of manic phases of bipolar disorder: critical synthesis of international guidelines].Rapid cycling bipolar disorder: historical overview and focus on emerging treatments.