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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Creighton University
Shire Pharmaceutical Development
Information provided by: Creighton University
ClinicalTrials.gov Identifier: NCT00325286
  Purpose

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 IV

MedlinePlus related topics:   Bipolar Disorder   

ChemIDplus related topics:   Carbamazepine    Lithium carbonate    Lithium citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Open Label Prophylaxis Study of Lithium Plus Extended- Release Carbamazepine (Equetro®) Combination for Rapid Cycling Bipolar Disorder

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:   20
Study Start Date:   May 2006
Estimated Study Completion Date:   March 2008

Arms Assigned Interventions
1: Experimental
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

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325286

Locations
United States, Nebraska
Creighton University Department of Psychiatry    
      Omaha, Nebraska, United States, 68131

Sponsors and Collaborators
Creighton University
Shire Pharmaceutical Development

Investigators
Principal Investigator:     Sriram Ramaswamy, M.D.     Creighton University    
  More Information


Responsible Party:   Creighton University ( Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry )
Study ID Numbers:   05-13934
First Received:   May 10, 2006
Last Updated:   December 13, 2007
ClinicalTrials.gov Identifier:   NCT00325286
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Affective Disorders, Psychotic
Carbamazepine
Mental Disorders
Bipolar Disorder
Mood Disorders
Lithium Carbonate
Psychotic Disorders
Lithium

Additional relevant MeSH terms:
Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Antimanic Agents
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on October 03, 2008




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