Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipol… (NCT00592358) | Clinical Trial Compass
TerminatedPhase 4
Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder
Stopped: Slow enrollment.
United States17 participantsStarted 2007-11
Plain-language summary
This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. Specific hypotheses are as follows:
Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.
Hypothesis 2: Invega -associated improvement in bipolar disorder symptomatology in children and adolescents will translate into improved functional capacities (neuropsychological, social, and occupational), as well as an increased quality of life throughout treatment.
Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out rate and absence of major side effects.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female outpatients 6-17 years of age (inclusive).
. Subjects with the diagnosis of Bipolar or Bipolar Spectrum Disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview. 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 display fewer elements in Criteria B (only require 2 items for elation category and 3 for irritability).
. Subjects must score ≥ 20 on the YMRS.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Symptoms Measured by Young Mania Rating Scale (YMRS)
Timeframe: Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)
. 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.
Exclusion criteria
0. For concomitant therapy used to treat ADHD, subjects must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy will not change throughout the duration of the study.
. 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.
. Any other concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication portion of the protocol.