Long-term Antipsychotic Pediatric Safety Trial
キーワード
概要
説明
Prospective, multi-site, Phase 4, longitudinal observational study designed to systematically collect robust longitudinal post-marketing safety and quality of life data about multi-year pediatric treatment with risperidone or aripiprazole. Screening may occur for up to 37 days prior to enrollment. Assessments will occur at in-person visits planned at months 0, 6, 12, 18 and 24, and at unscheduled, in-person visits that study staff request when the participant switches or stops antipsychotic monotherapy with risperidone or aripiprazole, adds or stops treatment with a weight modifying agent, becomes pregnant, chooses to withdraw from the study prematurely or, has an ongoing Serious Adverse Event (SAE) that requires further assessment. Monthly remote interim contacts occurring between in-person visits will monitor for changes (other than dose related) in antipsychotic therapy or weight modifying treatments, potential SAEs, and potential pregnancy. The participant, his/her parent/guardian, and the participant's personal psychotropic- prescribing medical provider (PPPMP) will make any and all decisions related to antipsychotic medications; any other medications; and the participant's current mental state, developmental/psychiatric condition, and level of risk for potential harm to self or others independent of the study procedures and assessments. Study staff (SS) will share all lab results and changes in the participant's AEs or clinical presentation, which the study medical clinician (SMC) considers medically concerning based on the participant's assessment during in-person visits, with the participant's PPPMP. If an emergency safety concern is evident during an in-person visit, the SMC will immediately assess the participant, following medical standard-of- care procedures, to determine whether the participant is safe to leave the clinic or requires additional emergency care. If new or worsening symptoms are reported by the participant or parent/guardian during remote interim contacts, the participant and/or parent/guardian will be instructed to contact the PPPMP directly.
日付
| 最終確認済み: | 04/30/2020 |
| 最初に提出された: | 04/17/2018 |
| 提出された推定登録数: | 04/29/2018 |
| 最初の投稿: | 05/10/2018 |
| 最終更新が送信されました: | 05/14/2020 |
| 最終更新日: | 05/17/2020 |
| 実際の研究開始日: | 01/09/2019 |
| 一次完了予定日: | 06/30/2021 |
| 研究完了予定日: | 06/30/2021 |
状態または病気
介入/治療
Drug: Risperidone group
Drug: Aripiprazole group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Risperidone group Rispridone, n=350, including 30 children 3 - <6 years old and 320 children 6 - <18 years old. ~50% - ~80% of the entire group will have <90 days of prior treatment with any antipsychotic. | Drug: Risperidone group Medications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder |
| Aripiprazole group Aripiprazole group, n=350, including 30 children 3 - <6 years old and 320 children 6 - <18 years old. ~50% - ~80% of the entire group will have ≤90 days of prior treatment with any antipsychotic. | Drug: Aripiprazole group Medications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder |
適格基準
| 研究の対象となる年齢 | 3 Years に 3 Years |
| 研究に適格な性別 | All |
| サンプリング方法 | Non-Probability Sample |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Parent/guardian has provided informed consent 2. Participant has provided assent if developmentally appropriate and as required by the institutional review board (IRB) 3. 3 - <18 years of age inclusive at time of M0 visit 4. Participant, when developmentally appropriate, and parent/guardian are: 1. Willing to authorize exchange of information between the SS and the participant's PPPMP and/or other significant medical provider 2. Affirm participant's use at M0 visit of either risperidone or aripiprazole mono-antipsychotic therapy as prescribed by participant's PPPMP 5. Based on their age at the time of M0 visit, participant is receiving aripiprazole or risperidone at the dose and for the diagnoses as listed below: 1. Participants ages 3 - < 6 years can have any diagnosis and any dose 2. Participants ages ≥ 6 - <18 years at the doses and for the diagnoses listed below Labeled Indications (Closely Related Disorders) Aripiprazole 2-30 mg/day - Irritability associated with autistic disorder: (Irritability in autism spectrum disorder) - Treatment of Tourette's disorder: (Tourette's disorder, persistent (chronic) motor or vocal tic disorder) - Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar l disorder: (Bipolar spectrum disorders including disruptive mood dysregulation disorder) - Schizophrenia: (Schizophrenia spectrum disorders including schizoaffective disorder, psychosis not otherwise specified, and delusional disorder) Risperidone 0.25-6 mg/day - Irritability associated with autistic disorder: (Irritability in autism spectrum disorder) - Bipolar Mania: (Bipolar spectrum disorders including disruptive mood dysregulation disorder) - Schizophrenia: (Schizophrenia spectrum disorders including schizoaffective disorder, psychosis not otherwise specified, and delusional disorder) - MYCITE® (aripiprazole) and all forms of injectables are not permitted in this study 6. Guardian anticipates risperidone or aripiprazole treatment will continue for ≥6 months Exclusion Criteria: 1. History of prior or current diagnosis of an eating disorder or meets diagnostic criteria for an eating disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and determined by psychiatric exam 2. Pre-existing or suspected major medical, metabolic, or genetic condition that is expected to be associated with weight, cardiovascular, neuromotor, or endocrine problems 3. Known or self-reported pregnancy 4. Taking antipsychotic medication other than either risperidone or aripiprazole at the time of M0 visit 5. Contraindications to participation in the study in the opinion of the SMC 6. Unwilling or unable to provide back-up family contact information |
結果
主な結果の測定
1. Change in BMI z-score [Baseline, 24 months]
二次的な結果の測定
1. Measure of weight change [Baseline, 24 months]
2. Metabolic measures associated with risk of diabetes and cardiovascular disease [Baseline, 24 months]
3. Prolactin related outcomes [Baseline, 24 months]
4. Uniformly Elicited Events of Special Interest [Baseline, 24 months]
5. Adverse effects [Baseline, 24 months]
6. Suicidality [Baseline, 24 months]
7. Neuromotor effects [Baseline, 24 months]
8. AEs (Adverse Events) [Baseline, 24 months]
9. Benefits - Pediatric Quality of Life Inventory [Baseline, 24 months]
10. Benefit - School and Work Questionnaire (SWQ) [Baseline, 24 months]
11. Benefits- Caregiver Strain Questionnaire (CSQ) [Baseline, 24 months]
12. Benefits - Delighted-Terrible Faces Scale (DTFS) [Baseline, 24 months]
13. PK CL/F [24 months]
14. PK Vss/F [24 months]
15. PK AUCss [24 months]
16. PK Cmax [24 months]
17. PK Tmax [24 months]
18. PK T1/2 [24 months]
