Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder

• Status: Unknown status
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Creighton University
• Collaborator: Shire
• Treatments: Carbamazepine; Lithium Carbonate

Criteria

Inclusion Criteria:

1. Subjects, 19 years and older with DSM-IV defined Bipolar Disorder with a history of the rapid cycling within the past 12 months.

2. Subjects may be either in a manic, mixed or depressive phase at time of study entry.

3. 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 Criteria:

1. Subjects with a lifetime history of Schizophrenia or Schizoaffective Disorder

2. If patients are on thyroid replacement therapy they have to on stable doses for the past 3 months at study enrollment.

3. Presence of active suicide ideations or score of > 3 on the suicide subscale of the 17

• item HAM-D.

4. Current substance dependence (excluding nicotine) defined as no dependence criteria for 30 days prior to study enrollment

5. Subjects with a history of non-response to carbamazepine or lithium

6. Subjects who are pregnant or planning to become pregnant

7. Subjects with a history of allergic/idiosyncratic reaction or intolerability to carbamazepine or lithium.