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

Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old With Bipolar I, Bipolar II and Bipolar Spectrum Disorder

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.

Study Overview

• Status: Withdrawn
• Conditions: Bipolar Disorder; Mania; Bipolar I; Bipolar II; Bipolar Spectrum Disorder
• Intervention / Treatment: Drug: Latuda (Lurasidone)

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02144
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects 6-17 years of age
2. Subjects must weigh at least 20 kg
3. 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)
4. Subjects must score ≥ 20 on the YMRS (Young Mania Rating Scale)
5. 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.
6. Subjects and their legal representative must be considered reliable reporters.
7. 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).
8. Subject must be able to participate in mandatory blood draws.
9. Subject must be able to swallow pills.
10. Subjects with co-morbid PDD (Pervasive Developmental Disorder) and depressive disorders will be allowed to participate in the study provided they do not meet any of the exclusionary criteria.
11. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Latuda (Lurasidone)	Drug: Latuda (Lurasidone); Latuda® (lurasidone) tablets taken by mouth once daily, between 20 mg and 120 mg a day.; Other Names: Latuda; Lurasidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Janet Wozniak, M.D., Massachusetts General Hospital Clinical and Research Program in Pediatric Psychopharmacology

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Pediatric; Bipolar Disorder; Mania; Bipolar I; Bipolar II; Bipolar Spectrum Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Bipolar and Related Disorders; Disease; Bipolar Disorder; Mania; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: 2013-P-001524