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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be seen weekly during preliminary phase and biweekly during the open label phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be seen weekly during preliminary phase and biweekly during the open label phase
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
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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
97,272 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
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