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New treatment option for Bipolar Disorder
Official title Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder
ClinicalTrials.gov ID: NCT05627492
What this study is testing
- What it's testing
- The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full year of DBT in a previous study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 25
You may be able to join if
- The participant must meet all of the to eligible for this clinical trial:
- Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021);
- English speaking;
- Age 14 years, 0 months to 26 years, 11 months;
- Meets diagnostic criteria for bipolar disorder by KSADS-PL(\< 20 years of age) OR SCID-5-RV (≥ 20 years of age) OR have a biological parent/sibling...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- A life-threatening medical condition requiring immediate treatment;
- Current victim of sexual or physical abuse;
- Current substance use disorder other than mild cannabis or alcohol use disorder;
- Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL, parent...
See the full eligibility criteria
- The participant must meet all of the to eligible for this clinical trial:
- Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021);
- English speaking;
- Age 14 years, 0 months to 26 years, 11 months;
- Meets diagnostic criteria for bipolar disorder by KSADS-PL(\< 20 years of age) OR SCID-5-RV (≥ 20 years of age) OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV;
- Followed by a psychiatrist who provides ongoing care;
- If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium);
- Able and willing to give informed consent/assent to participate.
- An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- A life-threatening medical condition requiring immediate treatment;
- Current victim of sexual or physical abuse;
- Current substance use disorder other than mild cannabis or alcohol use disorder;
- Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records that would interfere with...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.