NCT02623504

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

A Double Blind Study To Evaluate the Dose Tolerance and Safety of Equetro (Carbamazepine) Versus Placebo Followed by a Long-Term Maintenance in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Validus Pharmaceuticals · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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

Detailed description

The primary objective of this study is to evaluate under double blind conditions the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an open label and long term maintenance treatment on extended release Equetro in children and adolescents aged 10-17 year diagnosed with acute manic or mixed bipolar I disorder. The safety evaluations will be based on the occurrence of treatment-emergent adverse events, laboratory values, physical examination, vital signs ECG and trough serum level of study medication. The secondary objective is to evaluate under double blind conditions the efficacy of extended release Equetro versus placebo followed by an open label and long term maintenance treatment on extended release Equetro in children and Adolescents Aged 10-17 years diagnosed with acute manic or mixed Bipolar I disorder. Efficacy evaluations will be based on the measures of YMRS, CGI-S, CGI-I, CDRS-R. Manic episodes over double blind and open label periods will comprise the use of study medication and duration of night time sleep as monitored using a daily diary. Subject's will be enrolled in the double blind period for two months and evaluated on a weekly basis. Once completing the db phase they will continue on Equetro for long term maintenance for an additional six months. Placebo subject will have the opportunity to continue for another eight months in the study. The first two months will be the titration period as was done in the db phase and then they will have the option to continue in the study for an open long term maintenance for and additional 6 months. During the maintenance period subjects will be evaluated for safety and efficacy on a monthly basis. At the end of the study there will be a 30 day follow-up.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-24
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2015-12-07
• Last updated: 2023-03-03

Locations

4 sites across 1 country: United States