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

NCT ID: NCT01932541

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Latuda (Lurasidone)

Group Type: EXPERIMENTAL

Latuda (Lurasidone)

Intervention Type: DRUG

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

Interventions

Latuda (Lurasidone)

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

Intervention Type: DRUG

Other Intervention Names

Lurasidone; Latuda

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Janet Wozniak, MD

Associate Professor of Psychiatry, Harvard Medical School; Director, Pediatric Bipolar Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet Wozniak, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital Clinical and Research Program in Pediatric Psychopharmacology

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2013-P-001524

Identifier Type: -

Identifier Source: org_study_id