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

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ClinicalTrials.gov Identifier: NCT00325286
Recruitment Status : Unknown
Verified December 2007 by Creighton University.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2006
Last Update Posted : December 14, 2007
Sponsor:
Collaborator:
Shire
Information provided by:
Creighton University

Tracking Information
First Submitted Date  ICMJE May 10, 2006
First Posted Date  ICMJE May 12, 2006
Last Update Posted Date December 14, 2007
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2006)
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.
Change History Complete list of historical versions of study NCT00325286 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2006)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder
Official Title  ICMJE Open Label Prophylaxis Study of Lithium Plus Extended- Release Carbamazepine (Equetro®) Combination for Rapid Cycling Bipolar Disorder
Brief Summary 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.
Detailed Description

Open label Design with Lithium plus Extended release carbamazepine combination for 6 months. Extended release carbamazepine at doses of 1600 mg/day will be utilized. Lithium dosage will be adjusted to maintain therapeutic blood levels.

Patient Population: N = 20.

Primary and Secondary Efficacy Endpoints:

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 affective symptoms
  • Hospitalization for an affective episode
  • Increase of more than 50% in HAM-D and YMRS scores from baseline

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 Scale (HAM-D), Young Mania Rating Scale (YMRS), Clinical Global Severity Scale (CGI -S), Clinical Global Improvement Scale (CGI-I) scores at baseline and scores during treatment with ERC-CBZ.

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.

Study Procedures:

Preliminary Phase: The Structured Clinical Interview Diagnostic Schedule (SCID), medical & psychiatric history and baseline laboratory testing, EKG; pregnancy test will be obtained to ensure study eligibility. Eligible subjects will receive ERC-CBZ at starting doses ranging from 100 to 200 mg b.i.d. depending on clinical presentation and further titration up to a maximum dose of 1600 mg/day will be done at the discretion of the investigator. This titration phase will not extend beyond 2 weeks during which changes in concomitant medications will be allowed. Next, all psychotropics excluding lithium, ERC-CBZ and benzodiazepines will be tapered over a 2-week period. During the preliminary phase subjects will be seen weekly and assessments will be made using the HAM-D, YMRS, CGI -S, CGI-I, AE, and Concomitant medications

Open Label Phase: Subjects on lithium and ERC-CBZ therapy will enter this phase for 6 months. Changes to both lithium and ERC-CBZ will be permitted during this phase with serum levels to guide titration. Use of lorazepam, as a rescue medication will be permitted. Study visits will be every biweekly for 6 months. The HAM-D, YMRS and CGI-S, CGI-I, AE, concomitant medications will be assessed at each visit. Compliance will be assessed by pill counts at each study visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Treatment with lithium and extended release carbamazepine
Intervention: Drug: Lithium Plus Extended- Release Carbamazepine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 10, 2006)
20
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00325286
Other Study ID Numbers  ICMJE 05-13934
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry, Creighton University
Study Sponsor  ICMJE Creighton University
Collaborators  ICMJE Shire
Investigators  ICMJE
Principal Investigator: Sriram Ramaswamy, M.D. Creighton University
PRS Account Creighton University
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP