Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old

NCT01932541 | Withdrawn Phase 4

• 1 other identifier: 2013-P-001524
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an 8-week open-label trial testing Lurasidone (Latuda®) as a treatment for mania in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum disorders. We hypothesize that Lurasidone will be safe, tolerable, and effective in improving the core symptoms of bipolar disorders in children and adolescents ages 6-17.

Conditions

Mania; Bipolar I; Bipolar II; Bipolar Spectrum Disorder; Bipolar Disorder

Keywords

Bipolar Disorder; Mania; Bipolar I; Bipolar II; Bipolar Spectrum Disorder; Pediatric

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale

  This is a widely used instrument that assesses symptoms of mania in clinical trials of adult and pediatric subjects.

  Change from baseline at 12 weeks

Study Arms (1)

Latuda (Lurasidone)

EXPERIMENTAL

Drug: Latuda (Lurasidone)

Interventions

Latuda (Lurasidone) DRUG

Latuda® (lurasidone) tablets taken by mouth once daily, between 20 mg and 120 mg a day.

Also known as: Lurasidone, Latuda

Latuda (Lurasidone)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects 6-17 years of age
• Subjects must weigh at least 20 kg
• Subjects with the diagnosis of bipolar I, bipolar II, or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features), by DSM-IV (Diagnostic and Statistical Manual IV), as manifested in clinical evaluation and/or the Mania module of the structured interview, completed by the study clinician. Bipolar Spectrum Disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but displays fewer elements in Criteria B (only require 2 items for elation category and 3 for irritability)
• Subjects must score ≥ 20 on the YMRS (Young Mania Rating Scale)
• Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
• Subjects and their legal representative must be considered reliable reporters.
• Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document (if ≥ 7 years old).
• Subject must be able to participate in mandatory blood draws.
• Subject must be able to swallow pills.
• For concomitant therapy used to treat ADHD (Attention Deficit Hyperactivity Disorder), subjects must have been on a stable dose of the medication for 1 month prior to study enrollment, and the dose of the ADHD therapy cannot change throughout the duration of the study.

You may not qualify if:

• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
• Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• Uncorrected hypothyroidism or hyperthyroidism.
• Non-febrile seizures without a clear and resolved etiology.
• DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.
• Judged clinically to be at serious suicidal risk or have a C-SSRS (Columbia Suicide Severity Rating Scale) score ≥ 4.
• Any other concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication portion of the Protocol.
• Current diagnosis of schizophrenia.
• Mental retardation (IQ \< 75)
• Pregnant or nursing females
• Known hypersensitivity to Latuda®
• A non-responder or history of intolerance to Latuda®, after treatment at adequate doses as determined by the clinician.
• Severe allergies or multiple adverse drug reactions.
• Subjects with a hematological disorder.
• Subjects with diabetes.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

MeSH Terms

Conditions

Mania; Bipolar Disorder

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janet Wozniak, M.D.

  Massachusetts General Hospital Clinical and Research Program in Pediatric Psychopharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Harvard Medical School; Director, Pediatric Bipolar Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital.

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 30, 2013
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

US (1)