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

NCT03567681 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-06-26

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

Extended release oxcarbazepine vs Immediate release oxcarbazepine

Extended release oxcarbazepine vs Immediate release oxcarbazepine

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Collaborative Care Initiative, LLC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-13
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567681 on ClinicalTrials.gov