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Mood Stabilizer

Lithium vs Divalproex for Pediatric Bipolar Disorder (PBC Trial)

Phase 3
Waitlist Available
Led By Robert A. Kowatch, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
7.0 - 17 years of age
Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

PBC Trial Summary

This trial will compare the effectiveness of lithium, divalproex, and placebo in treating bipolar I disorder in children and adolescents.

Who is the study for?
This trial is for children and adolescents aged 7 to 17 with Bipolar I Disorder, experiencing a mixed or manic episode. They must have normal intelligence, no current serious medical conditions requiring medication, and not be at serious risk of suicide. Sexually active females must use reliable contraception.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of lithium, divalproex, and a placebo in treating the acute phase of bipolar disorder in young participants. It will determine which treatment is more effective for managing symptoms.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal issues like nausea or diarrhea, tremors, changes in weight or appetite, hair loss (with divalproex), increased thirst or urination (with lithium), and possible impact on kidney or liver function.

PBC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 7 and 17 years old.
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I have been diagnosed with Bipolar I Disorder.
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I am not on medication for any chronic illnesses.

PBC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Young Mania Rating Scale (YMRS) & Clinical Global Impressions I (CGI-I)
Secondary outcome measures
CDRS & MRS

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
813 Previous Clinical Trials
6,531,389 Total Patients Enrolled
3 Trials studying Bipolar Disorder
245 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,771 Previous Clinical Trials
2,645,142 Total Patients Enrolled
145 Trials studying Bipolar Disorder
63,432 Patients Enrolled for Bipolar Disorder
University of CincinnatiOTHER
427 Previous Clinical Trials
634,218 Total Patients Enrolled
22 Trials studying Bipolar Disorder
1,723 Patients Enrolled for Bipolar Disorder

Media Library

Bipolar Disorder Research Study Groups:

Frequently Asked Questions

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

Who would be the ideal candidate for this clinical trial?

"This psychiatric clinical trial is testing a new intervention for manic disorder in children and adolescents aged 7-18. A total of 154 participants are needed for the study."

Answered by AI

Is the target age group for this research over 20 years old?

"As this clinical trial only accepts patients that meet specific age requirements, the minimum age of 7 and maximum age of 18 years old."

Answered by AI

Could you please explain the risks associated with this treatment?

"The safety of this treatment was scored a 3 by our team at Power. This is because the trial is currently in Phase 3, which suggests that there is both some evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Are people still being signed up for this experiment?

"Unfortunately, this trial is no longer enrolling patients. It was originally posted on March 1st 2001 but the listing was last updated over 15 years ago on February 22nd 2006. There are, however, many other trials (163 to be exact) that might have open spots for you."

Answered by AI
~6 spots leftby Mar 2025