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DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder

NCT02623504 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-03-03

No results posted yet for this study

Summary

A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long term maintenance treatment in children and adolescents aged 10-17 years diagnosed with acute manic or mixed Bipolar I Disorder

Conditions

Interventions

DRUG

Carbamazepine

200-1200 mg by mouth daily given in divided doses in the morning and the evening. Doses are titrated weekly in 200 mg increments based upon subject's response.

DRUG

Placebo

Dosage to match active treatment by mouth twice daily in the morning and in the evening.

Sponsors & Collaborators

  • Validus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Robert Findling, MD · John Hopkins - Kennedy Krieger Research

  • Lawrence Ginsberg, MD · Red Oak Psychiatry

  • Morteza Nadjafi, MD · APG Research

  • Mohd Azfar Malik, MD · Psych Care Consultants Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-24
Primary Completion
2018-11-01
Completion
2018-11-01

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02623504 on ClinicalTrials.gov