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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Creighton University.
Recruitment status was:  Active, not recruiting
Information provided by:
Creighton University Identifier:
First received: May 10, 2006
Last updated: December 13, 2007
Last verified: December 2007
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.

Condition Intervention Phase
Bipolar Disorder Drug: Lithium Plus Extended- Release Carbamazepine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Prophylaxis Study of Lithium Plus Extended- Release Carbamazepine (Equetro®) Combination for Rapid Cycling Bipolar Disorder

Resource links provided by NLM:

Further study details as provided by Creighton University:

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. [ Time Frame: Patients will be seen weekly during preliminary phase and biweekly during the open label phase ]

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 [ Time Frame: Patients will be seen weekly during the preliminary phase and biweekly during the open label phase ]

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Experimental: 1
Treatment with lithium and extended release carbamazepine
Drug: Lithium Plus Extended- Release Carbamazepine
Preliminary phase subjects receive ERC-CBZ starting dose range from 100 to 200 mg b.i.d. and further titration up to a maximum dose of 1600 mg/day done at the discretion of the investigator. Titration phase will not extend beyond 2 weeks.Open label phase subjects stabilized on lithium and ERC-CBZ therapy will enter this phase for 6 months
Other Name: Epitol, Tegretol

  Show Detailed Description


Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00325286

United States, Nebraska
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Principal Investigator: Sriram Ramaswamy, M.D. Creighton University
  More Information

Responsible Party: Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry, Creighton University Identifier: NCT00325286     History of Changes
Other Study ID Numbers: 05-13934
Study First Received: May 10, 2006
Last Updated: December 13, 2007

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers processed this record on September 21, 2017