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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Creighton University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Shire
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00325286
First received: May 10, 2006
Last updated: December 13, 2007
Last verified: December 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Carbamazepine
Lithium
Lithium Carbonate
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014