Bipolar DepressionPhase 4NCT00203567
Carbamazepine Extended-Release for the Treatment of Bipolar Depression
A Phase 4 study testing carbamazepine ER in people with Bipolar Depression, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- carbamazepine ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa Research and Education Advancement Corporation
Tuscaloosa, Alabama, 35404
About this study
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.
Read the 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. ).
- Conditions
- Bipolar Depression
- Being tested
- carbamazepine ER
- Keywords
- bipolar depression, carbamazepine ER, Equetro
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbamazepine ERDrug
Active study drug, no comparator
| Study group | Role | What they receive |
|---|---|---|
| Equetro | Active comparator | Equetro Receives: Drug: carbamazepine ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
The treatment phase will include Mean Change from Baseline to Endpoint (Week 8 LOCF) on the CGI-BP, Q-LES-Q, and Ham-A.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionFeb 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Investigators
- Lori L Davis, MD, Principal investigator, Tuscaloosa Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203567
- Sponsor's protocol ID
- TREAC Equetro in Bipolar
- Other IDs
- TREAC Equetro in Bipolar
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 24 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Swainston Harrison T, Keating GM. Extended-release carbamazepine capsules : in bipolar I disorder. CNS Drugs. 2005;19(8):709-16. doi: 10.2165/00023210-200519080-00006.
PubMed 16097852
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbamazepine Extended-Release for the Treatment of Bipolar Depression
- ClinicalTrials.gov ID
- NCT00203567
- Acronym / sponsor ID
- TREAC Equetro in Bipolar
- Conditions
- Bipolar Depression
- Keywords
- bipolar depression, carbamazepine ER, Equetro
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Aug 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. ).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Equetro | Active comparator | Drug: carbamazepine EREquetro |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbamazepine ERActive study drug, no comparator | Drug | Equetro |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2008.
- Background: PubMed 16097852Swainston Harrison T, Keating GM. Extended-release carbamazepine capsules : in bipolar I disorder. CNS Drugs. 2005;19(8):709-16. doi: 10.2165/00023210-200519080-00006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori L Davis, MD principal investigator
Tuscaloosa Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carbamazepine ER in people with Bipolar Depression, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00203567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2008.