Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).
研究概览
简要总结
This is an open trial that seeks to determine the safety and tolerability of using inositol for children and adolescents with bipolar disorder and comorbid anxiety disorders with an exploration of efficacy and dose-response.
详细描述
Anxiety disorders are common comorbidities among children and adolescents with bipolar disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to drug dependency. Inositol has shown benefits for bipolar depression in adults. This is an open multi-case control study. The investigators will enroll 20 children and adolescents ages 8-17 treated at the Child and Adolescent Bipolar Services (CABS) at Western Psychiatric Institute and Clinic. Participants' involvement will be 14 weeks, including the initial titration of the supplement, maintenance, and taper. Primary outcomes will include standard measures of mood and anxiety. Also, physiologic measures including body mass index and bedside glucose will be followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence in the medical record confirming the DSM-V diagnosis of bipolar disorder. If this documentation is not in the record, then the appropriate sections of K-SADS will be administered to confirm the diagnosis.
- •Evidence in the medical record confirming the DSM-V diagnosis of anxiety disorder including; separation anxiety disorder, generalized anxiety disorder, and/or social phobia. If this documentation is not present or is more than 2 years old, then the appropriate section of the K-SADS will be administered to confirm diagnosis.
- •At least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the Pediatric Anxiety Rating Scale (PARS).
- •On a stable dose of psychotropic medications for at least one month, with no major changes projected.
排除标准
- •Presence of prominent diarrhea.
- •Diagnosis of diabetes mellitus.
- •Presence of active suicidal ideation and behavior or psychosis. B-SSRS ideation score greater than
- •B-SSRS behavior score greater than
- •Weight less than 20 kg.
- •Known pregnancy.
研究组 & 干预措施
Inositol
Subjects will receive inositol
干预措施: Inositol (Drug)
结局指标
主要结局
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).
时间窗: Weeks 1-12
This assessment rates the clinician's view of the patient's anxiety severity prior to and after initiating myo-inositol. Scores range from 0-7. Higher scores mean worse outcome.
To measure the safety and tolerability of myo-inositol, a change from baseline on the Physical Symptom Checklist (Side Effect Rating Scale) will be measured.
时间窗: Weeks 1-14
This assessment is a parent and child report measure. Its scores range from 0 to 60. Higher scores are indicative of more physical and psychological symptoms and worse outcome.
To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit.
时间窗: Weeks 1-12
The B-SSRS probes for suicidal thoughts and behavior. The scores for both categories range from 0-5. If participants score greater than 1 on B-SSRS ideation or greater than 0 on B-SSRS behavior, then they cannot be enrolled or remain in the study. Higher scores mean worse outcome.
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using the Patient Global Index of Change Severity (PGIC-S).
时间窗: Weeks 1-12
This scale is a parent and child report tool that evaluates participants' anxiety and assesses if there has been a decline in clinical status. Answer options are "0-None", "1-Mild", "2-Moderate", and "3-Severe" and describe symptoms of anxiety. Higher scores mean worse outcome.
To measure the tolerability of myo-inositol, the number of participants who are able to remain on myo-inositol for the full treatment period (10-12 weeks) will be measured.
时间窗: Weeks 1-14
At study completion, the number of participants who remained on myo-inositol for the full 10-12 weeks will be counted.
To measure the tolerability of myo-inositol, the number of participants able to remain on the full dosage of myo-inositol for the full treatment period (10-12 weeks) will be measured.
时间窗: Weeks 3-8
Participants will be titrated up to the full dose of myo-inositol by Week 3 and will remain on the full dose for 6 weeks unless they cannot tolerate the dose. At study completion, the number of participants who remained on the full-dose of myo-inositol for the full 10-12 weeks will be counted.
To measure the safety of myo-inositol, a fingerstick blood test will be done to measure glucose levels at the first and final study visits.
时间窗: Week 1 & Week 10-12
A glucometer will be used to test the blood glucose levels of participants.
To measure the safety of myo-inositol, physical measurements (height and weight) will be obtained.
时间窗: Weeks 1-12
Myo-inositol is dosed by the weight of the participant. To make sure the participant is taking the correct dose, weight will be measured at each study visit. Height will only be measured at Week 1 to calculate BMI. Also, change in weight or BMI will be followed.
次要结局
- To measure the effectiveness of myo-inositol for mood symptoms, a change from baseline on the Moods and Feelings Questionnaire (MFQ) will be evaluated.(Weeks 1-12)
- To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Improvement (CGI-I) will be evaluated.(Weeks 2-12)
- To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Severity (CGI-S) will be evaluated.(Weeks 2-12)
- To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Brief Child Mania Rating Scale Parent Version (BCMRS-P) will be evaluated.(Week 1 & Weeks 10-12)
- To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Patient Global Index of Change Improvement (PGIC-I) will be evaluated.(Weeks 2-12)
- To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Patient Global Index of Change Severity (PGIC-S) will be evaluated.(Weeks 1-12)
- To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Self-Report for Childhood Related Emotional Disorders (SCARED) will be evaluated.(Weeks 1-12)
研究者
Ronald M. Glick, MD
Associate Professor
University of Pittsburgh