A Phase 1/2 interventional study of Inositol in Bipolar Disorder, Anxiety Disorders and Anxiety, sponsored by Ronald M. Glick, MD. Withdrawn at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Ronald M. Glick, MD · Phase 1/2, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
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Exclusion Criteria:
Subjects will receive inositol
Drug: Inositol
Subjects will receive inositol
Also known as: Myoinositol
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).
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.
Time frame: Weeks 1-12
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using the Patient Global Index of Change Severity (PGIC-S).
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.
Time frame: Weeks 1-12
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.
At study completion, the number of participants who remained on myo-inositol for the full 10-12 weeks will be counted.
Time frame: Weeks 1-14
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.
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.
Time frame: Weeks 3-8
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.
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.
Time frame: Weeks 1-14
To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit.
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.
Time frame: Weeks 1-12
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.
A glucometer will be used to test the blood glucose levels of participants.
Time frame: Week 1 & Week 10-12
To measure the safety of myo-inositol, physical measurements (height and weight) will be obtained.
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.
Time frame: Weeks 1-12
To measure the effectiveness of myo-inositol for mood symptoms, a change from baseline on the Moods and Feelings Questionnaire (MFQ) will be evaluated.
The Mood and Feelings Questionnaire (MFQ) is a child and parent report questionnaire that measures depressive symptoms in children and young adults. Scores range from 0 to 66. Higher score are indicative of increased depressive symptom severity and worse outcome.
Time frame: 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.
This assessment rates the clinician's view of the patient's anxiety improvement after initiating myo-inositol. Scores range from 0-7. Higher scores mean worse anxiety symptoms.
Time frame: 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.
This assessment rates the clinician's view of the patient's anxiety severity before and after initiating myo-inositol. Scores range from 0-7. Higher scores mean more anxiety symptoms.
Time frame: 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.
The BMRS-P is a 10-item inventory rated on a 4 point Likert type scale anchored by 0 (never/rare), 1 (sometimes), 2 (often), and 3 (very often). Its purpose is to measure changes in symptoms of pediatric bipolar disorder (PBD) as they change over time. Scores range from 0 to 30. Higher scores mean more symptom severity.
Time frame: 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.
This scale evaluates participants' anxiety and assesses if there has been an improvement in clinical status. Answer options are "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", and "Much Worse".
Time frame: 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.
This scale is a child and parent self-report instrument used to evaluate 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 more anxiety symptoms and worse outcome.
Time frame: 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.
The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia. The SCARED consists of 41 items and 5 factors that parallel the DSM-IV classification of anxiety disorders. Scores range from 0-82. Scores greater than or equal to 25 indicate the presence of an anxiety disorder and scores in different items indicate the type of anxiety disorder.
Time frame: Weeks 1-12
Plan to share: Yes — Upon request from other researchers, we will make available de-identified subject data, as appropriate.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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