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

NCT02623504 | Terminated Phase 4 DMC

• 1 other identifier: VAL-EQP-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

Brief 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

Bipolar Disorder

Keywords

Carbamazepine; Equetro; Bipolar I Disorder; Bipolar I Disorder in Children

Outcome Measures

Primary Outcomes (1)

• Dose tolerance and safety of Equetro based on occurrence of adverse events, lab values, physical exams, vital signs, ECG's, and trough serum levels of study medications

  Duration of the study (8-10 months)

Secondary Outcomes (6)

• Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using the Young Mania Rating Score (YMRS)

  Weekly during the double blind period (8 weeks), monthly during the maintenance period (6-8 months)

• Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using Clinical Global Impressions - Improvement and Severity (CGI-I, CGI-S)

  Weekly during the double blind period (8 weeks), monthly during the maintenance period (6-8 months)

• Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using the Children's Depression Rating Scale - Revised (CDRS-R)

  Weekly during the double blind period, monthly during the maintenance period

• Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the subject's manic episodes throughout the study period

  Duration of the study (8-10 months)

• Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the subject's weekly use of study medication

  Weekly for the duration of the study (8-10 months)

Study Arms (2)

Equetro

EXPERIMENTAL

200-1200 mg of Equetro (carbamazepine) by mouth given in divided doses in the morning and in the evening. Dosage is titrated in 200 mg increments weekly as needed according to subject response.

Drug: Carbamazepine

Placebo

PLACEBO COMPARATOR

Placebo dosage to match the active Equetro treatment given in 2 daily doses in the morning and in the evening.

Drug: Placebo

Interventions

Carbamazepine DRUG

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.

Also known as: Equetro

Equetro

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written, signed and dated informed consent from subject, parents or legal guardians.
• Subject must be willing to participate for the duration of the study (8-10 months)
• Subject must meet DSM-V criteria for a primary diagnosis of bipolar I disorder.
• MINI KID administered and ruled out other psychiatric diagnosis.
• ADHD Rating Scale-IV is ruled negative.
• YMRS Score 20 or greater
• CGI-S score of 4 or greater
• CGI-I Global Evaluation score of 4 or less
• Must be aged between 10 and 17 years
• Male and non-pregnant, non-lactating females who agree to comply with contraceptive requirements
• Functioning at an age appropriate level intellectually as deemed by the Investigator
• Subject has no co-morbid conditions that would affect efficacy, safety or tolerability or in any way interfere with the subject's participation in the study
• Subject, parents and legal guardians are able to and willing to comply with study procedures and restrictions
• Must have a satisfactory medical assessment with no clinically significant abnormalities
• Able to avoid grapefruit and grapefruit juice for the duration of the study

You may not qualify if:

• Subject has a current controlled or uncontrolled co-morbid psychiatric that could interfere with clinical assessments or study conduct.
• Naive subjects whose symptoms are being controlled on their prescribed medication(s) will not be eligible to participate.
• History of lack of therapeutic response to an adequate trial of carbamazepine to treat bipolar I disorder
• Believed by the Investigator to be acutely at risk for suicidal or violent behavior towards him/her or others, or a history of a suicide attempt requiring general medical intervention
• Subject's bipolar diagnosis is believed secondary to traumatic injury or another general medical condition.
• A history or known presence of clinically significant cardiovascular, hepatic, hematological, immunological (including human immunodeficiency virus, gastro-intestinal or renal disease or any other unstable medical illness that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments
• A history of aplastic anemia, agranulocytosis or bone marrow depression
• A history of seizure disorder, other than a single childhood febrile seizure\\
• A history of severe, unstable asthma
• Currently hospitalized for the treatment of psychiatric symptoms.
• Presence of any mental disorder due to a general medical condition
• Presence of abnormal thyroid function that is not adequately treated in the opinion of the Investigator
• Use of ECT, any investigational drug, CYP450 3A4 inhibitors, antidepressants, anxiolytics, sedative hypnotics, antipsychotics, mood stabilizers, ADHD medications, or clozapine in a specified time period prior to the initiation of the study
• Use of any nutraceutical to include, but not limited to any over the counter herbal preparations e.g. Gingko Biloba, St John's Wort, Kava Kava and Ephedra.
• Positive urine drug screen

Sponsors & Collaborators

• Validus Pharmaceuticals: lead

Study Sites (4)

APG Research, LLC

Orlando, Florida, 32803, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

PsychCare Consultants

St Louis, Missouri, 63128, United States

Location

Red Oak Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Carbamazepine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert Findling, MD

  John Hopkins - Kennedy Krieger Research

  STUDY DIRECTOR

• Lawrence Ginsberg, MD

  Red Oak Psychiatry

  PRINCIPAL INVESTIGATOR

• Morteza Nadjafi, MD

  APG Research

  PRINCIPAL INVESTIGATOR

• Mohd Azfar Malik, MD

  Psych Care Consultants Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 7, 2015
• Study Start: October 24, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

US (4)