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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Carbamazepine Lithium carbonate Lithium citrate

U.S. FDA Resources

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

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Eligibility

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

Criteria

Inclusion Criteria:

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 Criteria:

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.

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

No publications provided

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

Study placed in the following topic categories:

Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Lithium Carbonate
Antipsychotic Agents
Antimanic Agents
Affective Disorders, Psychotic
Carbamazepine

Mental Disorders
Analgesics, Non-Narcotic
Mood Disorders
Psychotic Disorders
Analgesics
Peripheral Nervous System Agents
Lithium
Anticonvulsants

Additional relevant MeSH terms:

Tranquilizing Agents
Disease
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Antimanic Agents
Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes

Carbamazepine
Mental Disorders
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Mood Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Lithium

ClinicalTrials.gov processed this record on July 02, 2009