Enhanced Care for Bipolar Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Centre for Addiction and Mental Health, Toronto, CanadaBipolar DisorderEnhanced Care - Behavioral
Eligibility
13 - 23
All Sexes
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Study Summary

This trial will study how different "doses" of psychosocial treatment affect youth with bipolar disorder.

Treatment Effectiveness

Study Objectives

12 Primary · 1 Secondary · Reporting Duration: At the end of study completion (5 years)

Month 24
Change in risk behaviors/risk factors using the Safety Assessment
Month 24
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
Month 24
Change in affective lability using the Children's Affective Lability Scale (CALS)
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
24 months
Treatment Satisfaction Questionnaire (18-item)
Year 5
Number, frequency, and type of therapy sessions
Baseline
Childhood Trust Events Survey (CTES)
Baseline to 3 months
Change in suicidality Suicidal Ideation Questionnaire (SIQ)

Trial Safety

Trial Design

3 Treatment Groups

Level 1
1 of 3
Level 2
1 of 3
Level 3
1 of 3

Experimental Treatment

60 Total Participants · 3 Treatment Groups

Primary Treatment: Enhanced Care · No Placebo Group · N/A

Level 1
Behavioral
Experimental Group · 1 Intervention: Enhanced Care · Intervention Types: Behavioral
Level 2
Behavioral
Experimental Group · 1 Intervention: DBT Skills Training · Intervention Types: Behavioral
Level 3
Behavioral
Experimental Group · 1 Intervention: Dialectical Behavior Therapy Full Intervention · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced Care
2010
Completed Phase 4
~1270
DBT Skills Training
2015
N/A
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at the end of study completion (5 years)

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
327 Previous Clinical Trials
76,478 Total Patients Enrolled
13 Trials studying Bipolar Disorder
1,357 Patients Enrolled for Bipolar Disorder
Benjamin I Goldstein, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
236 Total Patients Enrolled
5 Trials studying Bipolar Disorder
236 Patients Enrolled for Bipolar Disorder

Eligibility Criteria

Age 13 - 23 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Does this clinical trial accept participants who are 18 years or older?

"This investigation is targeting adolescents aged between 13 and 23." - Anonymous Online Contributor

Unverified Answer

What is the size of the population participating in this research?

"Affirmative. Data hosted on clinicaltrials.gov states that this medical study, which was initially posted on November 1st 2021, is actively recruiting patients in need. Around 60 individuals must be enrolled from a single healthcare site." - Anonymous Online Contributor

Unverified Answer

Could I qualify for inclusion in this experiment?

"This research is accepting 60 individuals aged between 13 and 23 years old who are currently afflicted with manic disorder. In addition to this, the participants must have been receiving care from a CAMH psychiatrist at some point in time for eligibility." - Anonymous Online Contributor

Unverified Answer

Is recruitment still ongoing for this clinical research?

"Affirmative. The evidence hosted on clinicaltrials.gov confirms that the medical trial commenced recruitment on November 1st 2021 and is still active now, as of December 30th 2021. 60 participants will be required from one site to complete this study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.