Carbamazepine Extended-Release for the Treatment of Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by:
Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:
NCT00203567
First received: September 12, 2005
Last updated: June 23, 2008
Last verified: June 2008
  Purpose

To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the treatment of patients with Bipolar Disorder with a Major Depressive Episode.


Condition Intervention Phase
Bipolar Depression
Drug: carbamazepine ER
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: Carbamazepine Extended-Release for the Treatment of Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:
  • To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the treatment of patients with Bipolar Disorder with a Major Depressive Episode. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The treatment phase will include Mean Change from Baseline to Endpoint (Week 8 LOCF) on the CGI-BP, Q-LES-Q, and Ham-A. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2005
Study Completion Date: May 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Equetro
Equetro
Drug: carbamazepine ER
Active study drug, no comparator

Detailed Description:

Patients with Bipolar I or II Disorder with a Major Depressive Episode who sign informed consent and meet eligibility criteria will begin treatment with extended release carbamazepine (ERC-CBZ ). The dose of ERC-CBZ will be initiated at 200mg twice daily and increased as tolerated by 200mg/day every 3 days up to 1200mg/day by week 2 (target dose). Then the dose may be increased at the investigator's discretion, up to1600mg/day as tolerated by week 8, if needed for a greater therapeutic response. Efficacy will be assessed biweekly with the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression-Bipolar (CGI-BP). Safety is assessed biweekly with adverse events self-reports and laboratory evaluations. ).

  Eligibility

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

Inclusion Criteria:

  • Age 19 -65.
  • Diagnosis of Bipolar I or II Disorder, currently experiencing a major depressive episode without psychotic features, as confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.).
  • Must have experienced at least two previous mood episodes during the past 10 years, at least one of which was a hypomanic, full manic or mixed episode. The current depressive episode must be ≥ 2 weeks, but ≤ 2 years in duration.
  • Must currently have clinically significant depressive symptoms as defined by a CGI-S total score of ≥ 4.
  • Must have been washed out of all psychotropic medications (except for the allowed concomitant sedatives for insomnia) for their bipolar illness for at least 3 days for mood stabilizers and 1 week for antidepressants prior to study drug initiation (medications should be tapered at the investigator's discretion prior to washout), while continuing to meet entry criteria for depressive symptoms. Must be willing to discontinue all psychotropic medication (except for the allowed concomitant sedative for insomnia) during the study period.
  • No substance abuse/dependence for the previous 4 weeks (except for nicotine/caffeine)
  • Must give informed consent, and/or consent must be obtained from a legally acceptable representative (as required by IRB) prior to the initiation of any protocol required procedures.
  • Must be able to understand the nature of the study, agree to comply with the prescribed dosage regiments, report for regularly scheduled office visits and communicate to study personnel about adverse events and concomitant medication.
  • Women of childbearing potential (WOCBP) must use medically approved methods of birth control to avoid pregnancy throughout the study and for up to four weeks after completion of the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of the study.
  • Male or female, any race or ethic origin

Exclusion Criteria:

  • Patients with current diagnosis of delirium, dementia, amnestic or other cognitive disorder; schizophrenia; borderline or antisocial personality disorder; or any other mental disorder that would interfere with efficacy or safety evaluations or compliance.
  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to four weeks after completion of the study. Acceptable methods include oral, injectable or implanted contraceptives, intrauterine devices or barrier methods such as condoms, diaphragm, and spermicides. Women who are pregnant or breast-feeding, or who plan to become pregnant during the study.
  • Patients at significant risk of committing suicide or homicide based on history, mental status exam, or investigator's judgment.
  • Patients receiving psychotherapy (individual, group, marriage, or family therapy) unless participation has been regular for at least 3 months prior to randomization.
  • Patients with clinically significant thyroid pathology that would interfere with efficacy or safety evaluations and patients with a thyroid stimulating hormone (TSH) level > 60% above the upper limit of normal. Patients who are undergoing treatment for their thyroid pathology (e.g. thyroid supplementation) should be stable for at least two months prior to randomization.
  • Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the investigator.
  • Patients with a history of seizures (except for a single childhood febrile seizure, posttraumatic, alcohol withdrawal) or a history of severe head trauma, or stroke.
  • Patients on medications that may have serious drug-drug interactions with ERC-CBZ
  • Clinically significant abnormal laboratory tests results:

    • Platelets < 75,000/mm³
    • Hemoglobin < 9g/dL
    • Neutrophils, Absolute < 1000/mm³
    • SGOT (AST) >3x Upper limit of Normal
    • SGPT (ALT) > 3x Upper Limit of Normal
    • Creatinine >2mg/dL
    • Diastolic blood pressure >105 mmHg
    • TSH > 60% above Upper Limit of Normal
    • Detectable levels of cocaine and amphetamines in the urine drug screen.
    • Other abnormal laboratory test or vital sign result that in the investigator's judgment, is medically significant, in that it would impact the safety of the patient or the interpretation of the results.
  • Patients who are known to be allergic or hypersensitivity to carbamazepine (or alternative formulations).
  • Patients who have failed an adequate trial of carbamazepine (or alternative formulations) for bipolar depression.
  • Patients who have had recent treatment with a long-acting antipsychotic in which the last dose was less than one full cycle plus one week
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious disease) illness during the study.
  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: NCT00203567

Locations
United States, Alabama
Tuscaloosa Research and Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Shire
Investigators
Principal Investigator: Lori L Davis, MD Tuscaloosa VA Medical Center
  More Information

Publications:
Responsible Party: Lori L. Davis, M.D.; Chief, Research Service, Tuscaloosa Research Education & Advancement Corporation
ClinicalTrials.gov Identifier: NCT00203567     History of Changes
Other Study ID Numbers: TREAC Equetro in Bipolar, TREAC Equetro in Bipolar
Study First Received: September 12, 2005
Last Updated: June 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
bipolar depression
carbamazepine ER
Equetro

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014