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Mood Stabilizer

1 for Bipolar Disorder

Phase 4
Waitlist Available
Led By Sriram Ramaswamy, M.D.
Research Sponsored by Creighton University
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 up to 5 years
Awards & highlights

Summary

This is an open label design using Lithium plus extended release carbamazepine (Equetro) in combination for 6 months. Rapid cycling bipolar disorder is frequently treatment refractory and associated with repeated hospitalizations and complications. The results of this study will offer a promising approach to treat this complex disorder. The primary efficacy measure will be the time to relapse. Relapse will determined by the investigator based on the following: Need for additional pharmacotherapy for mood-related symptoms, hospitalization for an mood episode, increase of more than 50% in HAM-D and YMRS scores from the baseline visit.

Eligible Conditions
  • Bipolar Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Treatment with lithium and extended release carbamazepine

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Who is running the clinical trial?

Creighton UniversityLead Sponsor
125 Previous Clinical Trials
25,676 Total Patients Enrolled
2 Trials studying Bipolar Disorder
50 Patients Enrolled for Bipolar Disorder
ShireIndustry Sponsor
456 Previous Clinical Trials
97,258 Total Patients Enrolled
6 Trials studying Bipolar Disorder
180 Patients Enrolled for Bipolar Disorder
Sriram Ramaswamy, M.D.Principal InvestigatorCreighton University
3 Previous Clinical Trials
128 Total Patients Enrolled
~1 spots leftby Sep 2025
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