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

Status unconfirmed · Phase 4

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00325286

Run by

Creighton University

People needed

20

Starts

2006-05-01

Expected to finish

2008-03-01

Last updated by the study team

2007-12-14

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Creighton University Department of Psychiatry — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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