Trial Information

Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated with Bipolar I Disorder

A 3-week randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of asenapine as monotherapy in pediatric subjects with an acute manic or mixed episode associated with bipolar I disorder.

Patient Inclusion Criteria:

Each subject’s parent(s) or legal representative must be willing and able to provide written informed consent for the trial. Each subject must indicate assent/consent before study participation. Each subject’s parent(s) or legal representative must provide separate written informed consent for pharmacogentic testing and each subject must indicate assent/consent. Subjects whose parent(s) or legal representative are unwilling to provide written informed consent for pharmacogenetic testing, or who do not assent/consent to pharmacogenetic testing, may be included in the trial; however, pharmacogenetic samples must not be obtained.
Each subject must ≥ 12 years of age when indicating assent/consent to participate in the trial and ≤ 17 years of age when randomly assigned to treatment. A subject may be of either sex, and of any race/ethnicity.
Each subject must have a diagnosis of primary bipolar I disorder, current episode manic (296.4x), or mixed (296.6x) with or without psychotic features as confirmed by a structured clinical interview (K-SADS-PL) at screening. Primary is defined as being the most important clinical condition currently in need of treatment.
Each subject must have a Y-MRS total score ≥ 20 at Screening and Baseline (for subject who have a shortened Screening/tapering period, the Screening assessment will serve as the baseline measurement);
Each subject must have a severity of bipolar illness ≥ 4 as measured on the CGI-BP overall at Screening and Baseline (for subjects who have a shortened Screening/tapering period, the Screening assessment will serve as the baseline measurement);
Each subject must be a male, or a female who is not a childbearing potential (eg, surgically sterile) or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception; Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, medically prescribed intrauterine device (IUD), and hormonal contraceptives. If a female subject of childbearing potential, must agree to use a medically accepted method of contraception while receiving protocol specified medication and for 1 month after stopping the medication.
Each subject must understand the nature of the study;
Each subject must have tapered off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers; see Section 7.3.2, Table 1) prior to Baseline (the dosing cycle of depot neuroleptics must end prior to Baseline);
Each subject must be fluent in the language of the investigator, trial staff (including raters), and the informed consent;
Each subject must have a caregiver, or an identified responsible person, living with the subject, who is considered reliable by the investigator and who has agreed to provide support to the subject to ensure compliance with trial treatment, outpatient visits, protocol procedures;

Patient Exclusion Criteria:

The Subject has a diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, a pervasive developmental disorder, schizophrenia, schizoaffective disorder, post-traumatic stress disorder (PTSD), or obsessive compulsive disorder(OCD);
The subject has a primary Axis I diagnosis other than bipolar I disorder and has a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment;
The subject has a diagnosis of psychotic disorder or psychosis due to another medical condition or concomitant medication;
The subject has a known or suspected diagnosis of mental retardation, organic brain disorder, or an IQ <70;
The subject meets the DSM IV TR criteria for substance abuse or dependence (excluding nicotine and caffeine) within the past 6 months;
The subject has a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse;
The subject is at imminent risk of self-harm or harm to others, in the investigator’s opinion based on clinical interview or on responses provided on the C-SSRS. Subjects must be excluded at screening if they report suicidal ideation of Type 4 or 5 (ie. Suicidal ideation with intent, with or without a plan) in the past 2 months or suicidal behavior in the past 6 months as measured by the C-SSRS; subjects must be excluded at Baseline if they report suicidal ideation of Type 4 or 5 or suicidal behavior between Screening and Baseline as measured by the C-SSRS (for subjects who have a shortened Screening/tapering period, the Screening assessment will serve as Baseline measurement).
The subject has a history of tardive dyskinesia or tardive dystonia;
The subject has or had catatonic features;
The subject has uncontrolled or unstable diabetes or had a clinically significant abnormal blood glucose level at Screening that was confirmed by repeat testing
The subject has an uncontrolled or unstable clinically significant medical condition (eg. Renal, endocrine, respiratory, cardiovascular, hematological, immunologic, neurological or cerebrovascular disease, malignancy, or eating disorder) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the investigator
The subject has clinically significant abnormal laboratory , vital sign, physical examination, or ECG findings at Screening that , in the Investigator’s opinion, preclude the subject’s participation in the trial (potentially interferes with the ability to evaluate safety, tolerability and efficacy of trial medication or potentially impairs the subect’s ability to complete the trial);
A subject has laboratory and/or clinical evidence of clinically significanthepatic conditions, such as: • ALT or AST >3 x ULN and total bilirubin >2 x ULN; or • AST or AST >3 x ULN with the appearance of jaundice, worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
The subject is a female who is pregnant or breast-feeding;
The subject is a female with a positive pregnancy test at Screening, or with the intention to become pregnant during the course of the trial including the follow-up.
The subject has any known or suspected (non-febrile) seizure disorder;
The subject has known serological evidence of human immunodeficiency virus (HIV) antibody.
The subject has a history of neuroleptic malignant syndrome;
The subject has a positive drug/alcohol screen at the screening visit. (Subjects with positive psychotropic medication results may be included provided the finding can be accounted for by documented prescription use and the subject is able and willing to comply with protocol requirements regarding ecluded medications. Subjects with positive alcohol or cannabis results may be included at the investigator’s discretion, provided the investigator does not feel the subject is a compliance risk and the subject does not fulfill the criteria for substance abuse or dependence, as stated in Exclusion Criterion 4 (Section 7.6.1, Procedure 11])
The subject is under involuntary inpatient commitment;
The subject has used an investigational drug within 6 months prior to randomization;
The subject is participating in any other clinical trial’;
The subject has been treated previously in an asenapine trial.
The subject, if previously exposed to marketed asenapine, has been included if the subject was previously non-responsive to asenapine, experience an allergic reaction to asenapine for the subject’s current episode.
The subject is a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
The subject has been judged by the investigator to be medically non-compliant in the management of their disease.
The subject has been judged to be treatment resistant by the investigator or by the SDME.
The subject is unwilling to discontinue or, in the opinion of the investigator, is unable to safely taper off any prohibited treatment listed in Table 1 prior to the Baseline Visit without significant destabilization or increased suicidality (see Section 7.4.2.1 for details regarding concomitant treatments prior and during the trial).

R/D Clinical Research, Inc.
461 This Way
Lake Jackson, TX 77566
Phone: 979-297-3535
Fax: 979-297-1497
Email: mail@rdclinicalresearch.com

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Research Center Information: R/D Clinical Research, Inc.

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