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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 patients will be seen weekly during the preliminary phase and biweekly during the open label phase
Awards & highlights

Study 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 ~patients will be seen weekly during preliminary phase and biweekly during the open label phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be seen weekly during preliminary phase and biweekly during the open label phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary efficacy measure will be the time to relapse. Relapse will determined by; need for additional pharmacotherapy, hospitalization for an affective episode, increase of >/= 50% in HAM-D and YMRS scores.
Secondary outcome measures
The differences in the frequency of affective episodes in the 6-month prior to the treatment with ERC-CBZ and 6 months after treatment initiation will also be measured. Secondary efficacy measures will include; changes in the 17- Item Hamilton Depression

Trial Design

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

Find a Location

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
97,272 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder
2006. "Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00325286.
All > Obsessive Compulsive Disorder > Bipolar Disorder
~1 spots leftby May 2025
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