Status:
UNKNOWN
Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Shire
Conditions:
Bipolar Disorder
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief 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 w...
Detailed Description
Open label Design with Lithium plus Extended release carbamazepine combination for 6 months. Extended release carbamazepine at doses of 1600 mg/day will be utilized. Lithium dosage will be adjusted to...
Eligibility Criteria
Inclusion
- Subjects, 19 years and older with DSM-IV defined Bipolar Disorder with a history of the rapid cycling within the past 12 months.
- Subjects may be either in a manic, mixed or depressive phase at time of study entry.
- Subjects must be on lithium therapy for 6 months or longer. Stable lithium therapy will be defined as: No changes in lithium dosage for at least 2 weeks prior to study entry and a therapeutic lithium level (0.6 to 1.2 mEq) prior to study entry.
Exclusion
- Subjects with a lifetime history of Schizophrenia or Schizoaffective Disorder
- If patients are on thyroid replacement therapy they have to on stable doses for the past 3 months at study enrollment.
- Presence of active suicide ideations or score of \> 3 on the suicide subscale of the 17 - item HAM-D.
- Current substance dependence (excluding nicotine) defined as no dependence criteria for 30 days prior to study enrollment
- Subjects with a history of non-response to carbamazepine or lithium
- Subjects who are pregnant or planning to become pregnant
- Subjects with a history of allergic/idiosyncratic reaction or intolerability to carbamazepine or lithium.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00325286
Start Date
May 1 2006
End Date
March 1 2008
Last Update
December 14 2007
Active Locations (1)
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1
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131