Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression

Status unconfirmed · Phase 4

Conditions studied: Bipolar Depression, Treatment Effectiveness, Measure-based Guidance

In brief

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.

Key facts

Study ID

NCT03567681

Run by

Collaborative Care Initiative, LLC

People needed

120

Starts

2018-06-13

Expected to finish

2019-09-30

Last updated by the study team

2018-06-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• 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.

Where it is running

• Dauten Family Center for Bipolar Treatment Innovation — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.