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Treatment for Bipolar Disorder (TPEB Trial)

Phase 2

Recruiting

Research Sponsored by Paolo Cassano

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 and day 5 of tpbm treatment

Awards & highlights

TPEB Trial Summary

This trial will test whether transcranial light therapy can improve executive function in people with bipolar disorder.

Who is the study for?

This trial is for adults aged 18-65 with bipolar disorder who are currently experiencing symptoms of impulsivity. Participants must be able to consent and complete study procedures, not be pregnant, meet MRI safety requirements, and not be in a depressive, manic or mixed episode or psychotic state. They should not have had recent medication changes or substance use disorders.Check my eligibility

What is being tested?

The trial is testing transcranial photobiomodulation (tPBM), which involves applying near-infrared light to the forehead to stimulate brain metabolism. This could potentially improve executive function in individuals with bipolar disorder.See study design

What are the potential side effects?

Potential side effects of tPBM may include headache, fatigue, dizziness, irritability or discomfort at the site of application. However, as a non-invasive therapy using light, it's generally considered low-risk.

TPEB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 5 of tpbm treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and day 5 of tpbm treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 5 of tpbm treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Core-Binding Factor

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Paolo CassanoLead Sponsor

1 Previous Clinical Trials

28 Total Patients Enrolled

Media Library

Transcranial Photobiomodulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05408637 — Phase 2

Bipolar Disorder Clinical Trial 2023: Transcranial Photobiomodulation Highlights & Side Effects. Trial Name: NCT05408637 — Phase 2

Transcranial Photobiomodulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408637 — Phase 2

Frequently Asked Questions

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

To what sort of patients does this trial cater?

"This research is only open to people with manic disorder who are between 18 and 65 years old-- 20 in total."

Answered by AI

Are volunteers currently being accepted for this research project?

"Yes, the trial is still open and recruiting patients. 20 more individuals are needed to join the study at a single site. The original posting was on September 30th, 2020 with the most recent update being June 3rd, 2022."

Answered by AI

Does this medication have the government's okay for public consumption?

"While there is some evidence of safety from Phase 2 trials, none of the data collected supports efficacy. Our team rates this treatment as a 2 on our scale."

Answered by AI

Does this research include geriatric patients in its pool?

"The aim of this trial is to recruit patients who are young enough that they will not have age-related comorbidities and are old enough to provide informed consent."

Answered by AI

How many people are able to join this experiment?

"Yes, that is accurate. The trial was originally advertised on September 30th, 2022 and was most recently updated June 3rd, 2022. Currently, the study is only looking for 20 more patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcranial Photobiomodulation for Executive Function in Bipolar Disorder

Paolo Cassano 2022. "Transcranial Photobiomodulation for Executive Function in Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05408637.

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