Back to resultsInositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Primary Purpose
Bipolar Disorder, Anxiety Disorders, Anxiety
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Inositol
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring inositol
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Presence of prominent diarrhea.
- Diagnosis of diabetes mellitus.
- Presence of active suicidal ideation and behavior or psychosis. B-SSRS ideation score greater than 1. B-SSRS behavior score greater than 0.
- Weight less than 20 kg.
- Known pregnancy.
Sites / Locations
- Child and Adolescent Bipolar Services-WPIC Bellefield
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inositol
Arm Description
Subjects will receive inositol
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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".
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.
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.
Full Information
NCT ID
NCT02811133
First Posted
June 16, 2016
Last Updated
October 4, 2023
Sponsor
Ronald M. Glick, MD
Collaborators
The Fine Foundation, Jarrow Formulas Inc
1. Study Identification
Unique Protocol Identification Number
NCT02811133
Brief Title
Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Official Title
Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Funding terminated
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
October 4, 2023 (Actual)
Study Completion Date
October 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ronald M. Glick, MD
Collaborators
The Fine Foundation, Jarrow Formulas Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Anxiety Disorders, Anxiety
Keywords
inositol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inositol
Arm Type
Experimental
Arm Description
Subjects will receive inositol
Intervention Type
Drug
Intervention Name(s)
Inositol
Other Intervention Name(s)
Myoinositol
Intervention Description
Subjects will receive inositol
Primary Outcome Measure Information:
Title
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).
Description
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
Title
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using the Patient Global Index of Change Severity (PGIC-S).
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit.
Description
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
Title
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.
Description
A glucometer will be used to test the blood glucose levels of participants.
Time Frame
Week 1 & Week 10-12
Title
To measure the safety of myo-inositol, physical measurements (height and weight) will be obtained.
Description
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
Secondary Outcome Measure Information:
Title
To measure the effectiveness of myo-inositol for mood symptoms, a change from baseline on the Moods and Feelings Questionnaire (MFQ) will be evaluated.
Description
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
Title
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Improvement (CGI-I) will be evaluated.
Description
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
Title
To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Severity (CGI-S) will be evaluated.
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
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.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Presence of prominent diarrhea.
Diagnosis of diabetes mellitus.
Presence of active suicidal ideation and behavior or psychosis. B-SSRS ideation score greater than 1. B-SSRS behavior score greater than 0.
Weight less than 20 kg.
Known pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Glick, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Bipolar Services-WPIC Bellefield
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request from other researchers, we will make available de-identified subject data, as appropriate.
IPD Sharing Time Frame
Data will be shared, as deemed appropriate, starting 6 months after completion of the study for a period of 5 years.
IPD Sharing Access Criteria
Biomedical researcher involved in research activity in a related field and from an established research institution.
Citations:
PubMed Identifier
7675981
Citation
Benjamin J, Agam G, Levine J, Bersudsky Y, Kofman O, Belmaker RH. Inositol treatment in psychiatry. Psychopharmacol Bull. 1995;31(1):167-75.
Results Reference
background
PubMed Identifier
7793450
Citation
Benjamin J, Levine J, Fux M, Aviv A, Levy D, Belmaker RH. Double-blind, placebo-controlled, crossover trial of inositol treatment for panic disorder. Am J Psychiatry. 1995 Jul;152(7):1084-6. doi: 10.1176/ajp.152.7.1084.
Results Reference
background
PubMed Identifier
16542187
Citation
Eden Evins A, Demopulos C, Yovel I, Culhane M, Ogutha J, Grandin LD, Nierenberg AA, Sachs GS. Inositol augmentation of lithium or valproate for bipolar depression. Bipolar Disord. 2006 Apr;8(2):168-74. doi: 10.1111/j.1399-5618.2006.00303.x.
Results Reference
background
PubMed Identifier
8780431
Citation
Fux M, Levine J, Aviv A, Belmaker RH. Inositol treatment of obsessive-compulsive disorder. Am J Psychiatry. 1996 Sep;153(9):1219-21. doi: 10.1176/ajp.153.9.1219.
Results Reference
background
PubMed Identifier
9169302
Citation
Levine J. Controlled trials of inositol in psychiatry. Eur Neuropsychopharmacol. 1997 May;7(2):147-55. doi: 10.1016/s0924-977x(97)00409-4.
Results Reference
background
PubMed Identifier
7726322
Citation
Levine J, Barak Y, Gonzalves M, Szor H, Elizur A, Kofman O, Belmaker RH. Double-blind, controlled trial of inositol treatment of depression. Am J Psychiatry. 1995 May;152(5):792-4. doi: 10.1176/ajp.152.5.792.
Results Reference
background
PubMed Identifier
11386498
Citation
Palatnik A, Frolov K, Fux M, Benjamin J. Double-blind, controlled, crossover trial of inositol versus fluvoxamine for the treatment of panic disorder. J Clin Psychopharmacol. 2001 Jun;21(3):335-9. doi: 10.1097/00004714-200106000-00014.
Results Reference
background
PubMed Identifier
15654927
Citation
Silverstone PH, McGrath BM, Kim H. Bipolar disorder and myo-inositol: a review of the magnetic resonance spectroscopy findings. Bipolar Disord. 2005 Feb;7(1):1-10. doi: 10.1111/j.1399-5618.2004.00174.x.
Results Reference
background
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Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
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