ManiaPhase 4NCT01932541
Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old
A Phase 4 study testing Latuda (Lurasidone) in people with Mania and Bipolar I, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Mania, Bipolar I, Bipolar II
- What is being tested?
- Latuda (Lurasidone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02144
About this study
Official title: 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.
- Conditions
- Mania, Bipolar I, Bipolar II, Bipolar Spectrum Disorder, Bipolar Disorder
- Being tested
- Latuda (Lurasidone)
- Keywords
- Bipolar Disorder, Mania, Bipolar I, Bipolar II, Bipolar Spectrum Disorder, Pediatric
- Medical subject headings
- Mania, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latuda (Lurasidone)Drug
Also called Lurasidone, Latuda
Latuda® (lurasidone) tablets taken by mouth once daily, between 20 mg and 120 mg a day.
| Study group | Role | What they receive |
|---|---|---|
| Latuda (Lurasidone) | Experimental | Not described Receives: Drug: Latuda (Lurasidone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Mania Rating Scale
This is a widely used instrument that assesses symptoms of mania in clinical trials of adult and pediatric subjects.
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJan 2017
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: On hold due to competing departmental studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ManiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Wozniak, MD, Massachusetts General Hospital
- Investigators
- Janet Wozniak, M.D., Principal investigator, Massachusetts General Hospital Clinical and Research Program in Pediatric Psychopharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932541
- Sponsor's protocol ID
- 2013-P-001524
- Status last verified
- Jul 2018
- First submitted
- 20 Aug 2013
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01932541
- Acronym / sponsor ID
- 2013-P-001524
- Conditions
- Mania, Bipolar I, Bipolar II, Bipolar Spectrum Disorder, Bipolar Disorder
- Keywords
- Bipolar Disorder, Mania, Bipolar I, Bipolar II, Bipolar Spectrum Disorder, Pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: On hold due to competing departmental studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latuda (Lurasidone) | Experimental | Drug: Latuda (Lurasidone) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latuda (Lurasidone)Also: Lurasidone, LatudaLatuda® (lurasidone) tablets taken by mouth once daily, between 20 mg and 120 mg a day. | Drug | Latuda (Lurasidone) |
Primary outcome
Young Mania Rating Scale
Time frame: Change from baseline at 12 weeks
This is a widely used instrument that assesses symptoms of mania in clinical trials of adult and pediatric subjects.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
Related trials for Mania
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Healthy Adult Participants
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A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Wozniak, M.D. principal investigator
Massachusetts General Hospital Clinical and Research Program in Pediatric Psychopharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Latuda (Lurasidone) in people with Mania and Bipolar I, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young Mania Rating Scale (time frame: Change from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.