Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended release oxcarbazepine | Experimental | Six week of open treatment with extended release oxcarbazepine (Oxtellar XR) |
|
| Immediate release oxcarbazepine | Experimental | Six week of open treatment with Immediate release oxcarbazepine ( Trileptal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended release oxcarbazepine vs Immediate release oxcarbazepine | Drug | Extended release oxcarbazepine vs Immediate release oxcarbazepine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria: The protocol is designed to collect evidence from subjects during the course of routine clinical care. Enrollment is limited to consenting subjects with a current local care provider who agrees that oxcarbazepine is a reasonable next step in managing their bipolar depression
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dauten Family Center for Bipolar Treatment Innovation | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15023507 | Background | 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. | |
| 12927010 | Background | Ghaemi 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. |
| Label | URL |
|---|---|
| Platform for assessment and Measure-based Guidance | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Open randomization to parallel treatment groups
Not provided
Not provided
Outcome will be assessed by computer
Not provided
|
| 6 weeks |
| 17392295 | Background | Sachs 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. |
| 21935633 | Background | Morris 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. |