Bipolar DepressionPhase 4NCT03567681
Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression
A Phase 4 study testing Extended release oxcarbazepine vs Immediate release oxcarbazepine in people with Bipolar Depression and Treatment Effectiveness, run by Collaborative Care Initiative, LLC at 1 site in United States.
Trial summary
Consenting subjects with Bipolar depression will remain under the care of their local (psychiatric) care provider and be randomized to a six week course of one of two forms of oxcarbazepine (extended release or immediate release. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression, Treatment Effectiveness, Measure-based Guidance
- What is being tested?
- Extended release oxcarbazepine vs Immediate release oxcarbazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 30 Sep 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Inability to provide informed consent in English
- Current or lifetime diagnosis of epilepsy
- Pregnancy, breastfeeding or refusal to use birth control
- Another current Axis I diagnosis that is the primary focus of current treatment
- Substance or alcohol abuse/dependence at least 6 months prior enrollment
- Clinically significant abnormal results on clinical laboratories (including serum Creatinine, Sodium, and TSH) at baseline visit or within the prior 3 months.
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- Has started treatment with an FDA approved agent for Bipolar depression within the past 4 weeks
- Has received treatment with a long-acting injectable antipsychotic or electroconvulsive therapy during the 2 months prior screening
- If psychotropic medication outside of study limits is required (Note: Subjects may receive any concomitant medications prescribed by their local care providers with the following specific exceptions: Anti-anxiety medications (anxiolytics) exceeding equivalent of lorazepam 2 mg/d.
- Any long-acting injectable antipsychotic, More than one dopamine blocking agent, More than one standard antidepressant agent, FDA approved treatments for Bipolar depression (quetiapine, lurasidone, the combination of olanzapine and fluoxetine), or Electroconvulsive therapy.)
- Last dose of another anticonvulsant agent taken in the current week or within 5 half-lives of discontinuation (whichever is longer) prior to enrollment in the study
- Current treatment requires ongoing anti-anxiety medications (Anxiolytics) exceeding equivalent of lorazepam 2 mg/d.
- Use of oxcarbazepine (OXC) for treatment of current episode
- Previous known hypersensitivity to OXC or other related drugs, such as carbamazepine.
- History or presence of clinically significant, chronic medical condition, (e.g., hyponatremia, any neurological, gastrointestinal, endocrine, cardiovascular, pulmonary, hematological, immunologic, renal, hepatic or metabolic disease) that in the opinion of the clinician or investigator may affect the safety of the subject and the participation to the trial.
- Active Suicidality (MADRS item 10 >4) Active suicidal plan/intent or active suicidal thoughts in the past 6 months. Any suicide attempt within two years of the screening assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dauten Family Center for Bipolar Treatment Innovation
Boston, Massachusetts, 02114
About this study
Official title: An Exploratory Randomized Open Comparison of Oxtellar XR® vs Oxcarbazepine IR (Trileptal®) for the Treatment of Bipolar Depression
Consenting subjects with Bipolar depression will remain under the care of their local (psychiatric) care provider and be randomized to a six week course of one of two forms of oxcarbazepine (extended release or immediate release. Study outcomes will be assessed based on outcome measures administered to the subject at home by a computer simulated rater. Local care providers will receive "pre-assessment" reports ahead of each clinical visit, rate the Clinical Global Impression for Severity, and evaluate adverse effects. The primary outcome variable is "treatment effectiveness" operationally defined as the response rate X the completion rate.
Read the detailed description
This study will use the CCI Engaged Practice platform (EngagedPractice.Com) and will be conducted by a central "meta-site" reviewing eligibility, obtaining consent, randomizing subjects to treatment groups, training local care providers (LCP) to function as sub- investigators and monitoring outcomes.
Subjects will be randomized to six weeks of treatment with extended release oxcarbazepine or immediate release oxcarbazepine,while remaining under the care of their existing LCP.
LCP's will receive sub-investigator training for Good Clinical Practice, Human subjects protection, and all protocol specified assessments and procedures.
A computer simulated rater will collect outcomes (including MADRS, YMRS, PHQ-9, and adverse effects) ahead of each routine clinical visit and provide Measure-based Guidance o the LCP in the form of pre-assessment reports. The primary outcome variable is "treatment effectiveness" operationally defined as the response rate X the completion rate.
- Being tested
- Extended release oxcarbazepine vs Immediate release oxcarbazepine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended release oxcarbazepine vs Immediate release oxcarbazepineDrug
Also called Oxtellar vs Trileptal
Extended release oxcarbazepine vs Immediate release oxcarbazepine
| Study group | Role | What they receive |
|---|---|---|
| Extended release oxcarbazepine | Experimental | Six week of open treatment with extended release oxcarbazepine (Oxtellar XR) Receives: Drug: Extended release oxcarbazepine vs Immediate release oxcarbazepine |
| Immediate release oxcarbazepine | Experimental | Six week of open treatment with Immediate release oxcarbazepine ( Trileptal) Receives: Drug: Extended release oxcarbazepine vs Immediate release oxcarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effectiveness
Treatment Effectiveness is defined as Response Rate (Change from Baseline MADRS > or = 50%) X Completion Rate (completes week 6 of protocol while remaining on assigned treatment).
Measured: 6 weeks
Secondary outcomes (1)
Tolerability
Tolerability is defined as the rate of completion without severe adverse effects reported by subject or clinician. The subject will complete an adverse effects self-report module as part of their "Online Pre-assessment" 1-3 days prior to each clinical visit. The clinician will review the pre-assessment and complete their own adverse effect report at each visit. Items rated as severe by either the subject or the clinician will will be counted as severe. Subjects who remain on study medication for 6 weeks without severe adverse effects will be scored as tolerating treatment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start13 Jun 2018 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open randomization to parallel treatment groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collaborative Care Initiative, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567681
- Sponsor's protocol ID
- CCI-BD-001
- Status last verified
- Jun 2018
- First submitted
- 13 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Benedetti A, Lattanzi L, Pini S, Musetti L, Dell'Osso L, Cassano GB. Oxcarbazepine as add-on treatment in patients with bipolar manic, mixed or depressive episode. J Affect Disord. 2004 Apr;79(1-3):273-7. doi: 10.1016/S0165-0327(02)00407-X.
PubMed 15023507Ghaemi SN, Berv DA, Klugman J, Rosenquist KJ, Hsu DJ. Oxcarbazepine treatment of bipolar disorder. J Clin Psychiatry. 2003 Aug;64(8):943-5. doi: 10.4088/jcp.v64n0813.
PubMed 12927010Sachs GS, Nierenberg AA, Calabrese JR, Marangell LB, Wisniewski SR, Gyulai L, Friedman ES, Bowden CL, Fossey MD, Ostacher MJ, Ketter TA, Patel J, Hauser P, Rapport D, Martinez JM, Allen MH, Miklowitz DJ, Otto MW, Dennehy EB, Thase ME. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med. 2007 Apr 26;356(17):1711-22. doi: 10.1056/NEJMoa064135. Epub 2007 Mar 28.
PubMed 17392295Morris DW, Trivedi MH. Measurement-based care for unipolar depression. Curr Psychiatry Rep. 2011 Dec;13(6):446-58. doi: 10.1007/s11920-011-0237-8.
PubMed 21935633
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized Open Comparison of Oxtellar XR® vs Oxcarbazepine IR (Trileptal®) for the Treatment of Bipolar Depression
- ClinicalTrials.gov ID
- NCT03567681
- Acronym / sponsor ID
- CCI-BD-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Collaborative Care Initiative, LLCUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 13 Jun 2018 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- 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.
Consenting subjects with Bipolar depression will remain under the care of their local (psychiatric) care provider and be randomized to a six week course of one of two forms of oxcarbazepine (extended release or immediate release. Study outcomes will be assessed based on outcome measures administered to the subject at home by a computer simulated rater. Local care providers will receive "pre-assessment" reports ahead of each clinical visit, rate the Clinical Global Impression for Severity, and evaluate adverse effects. The primary outcome variable is "treatment effectiveness" operationally defined as the response rate X the completion rate.
Detailed description
This study will use the CCI Engaged Practice platform (EngagedPractice.Com) and will be conducted by a central "meta-site" reviewing eligibility, obtaining consent, randomizing subjects to treatment groups, training local care providers (LCP) to function as sub- investigators and monitoring outcomes.
Subjects will be randomized to six weeks of treatment with extended release oxcarbazepine or immediate release oxcarbazepine,while remaining under the care of their existing LCP.
LCP's will receive sub-investigator training for Good Clinical Practice, Human subjects protection, and all protocol specified assessments and procedures.
A computer simulated rater will collect outcomes (including MADRS, YMRS, PHQ-9, and adverse effects) ahead of each routine clinical visit and provide Measure-based Guidance o the LCP in the form of pre-assessment reports. The primary outcome variable is "treatment effectiveness" operationally defined as the response rate X the completion rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open randomization to parallel treatment groups
| Arm | Type | Receives |
|---|---|---|
| Extended release oxcarbazepine | Experimental | Drug: Extended release oxcarbazepine vs Immediate release oxcarbazepineSix week of open treatment with extended release oxcarbazepine (Oxtellar XR) |
| Immediate release oxcarbazepine | Experimental | Drug: Extended release oxcarbazepine vs Immediate release oxcarbazepineSix week of open treatment with Immediate release oxcarbazepine ( Trileptal) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Inability to provide informed consent in English
- Current or lifetime diagnosis of epilepsy
- Pregnancy, breastfeeding or refusal to use birth control
- Another current Axis I diagnosis that is the primary focus of current treatment
- Substance or alcohol abuse/dependence at least 6 months prior enrollment
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 |
|---|---|---|
| Extended release oxcarbazepine vs Immediate release oxcarbazepineAlso: Oxtellar vs TrileptalExtended release oxcarbazepine vs Immediate release oxcarbazepine | Drug | Extended release oxcarbazepine, Immediate release oxcarbazepine |
Primary outcome
Treatment Effectiveness
Time frame: 6 weeks
Treatment Effectiveness is defined as Response Rate (Change from Baseline MADRS > or = 50%) X Completion Rate (completes week 6 of protocol while remaining on assigned treatment).
1 secondary outcome
Tolerability
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 15023507Benedetti A, Lattanzi L, Pini S, Musetti L, Dell'Osso L, Cassano GB. Oxcarbazepine as add-on treatment in patients with bipolar manic, mixed or depressive episode. J Affect Disord. 2004 Apr;79(1-3):273-7. doi: 10.1016/S0165-0327(02)00407-X.
- Background: PubMed 12927010Ghaemi SN, Berv DA, Klugman J, Rosenquist KJ, Hsu DJ. Oxcarbazepine treatment of bipolar disorder. J Clin Psychiatry. 2003 Aug;64(8):943-5. doi: 10.4088/jcp.v64n0813.
- Background: PubMed 17392295Sachs GS, Nierenberg AA, Calabrese JR, Marangell LB, Wisniewski SR, Gyulai L, Friedman ES, Bowden CL, Fossey MD, Ostacher MJ, Ketter TA, Patel J, Hauser P, Rapport D, Martinez JM, Allen MH, Miklowitz DJ, Otto MW, Dennehy EB, Thase ME. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med. 2007 Apr 26;356(17):1711-22. doi: 10.1056/NEJMoa064135. Epub 2007 Mar 28.
- Background: PubMed 21935633Morris DW, Trivedi MH. Measurement-based care for unipolar depression. Curr Psychiatry Rep. 2011 Dec;13(6):446-58. doi: 10.1007/s11920-011-0237-8.
- Platform for assessment and Measure-based GuidanceLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Extended release oxcarbazepine vs Immediate release oxcarbazepine in people with Bipolar Depression and Treatment Effectiveness, run by Collaborative Care Initiative, LLC 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 0 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. 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?
Results are not available in the source record.
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?
Treatment Effectiveness (time frame: 6 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 NCT03567681, which also lists 4 linked publications.
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 26 Jun 2018.