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Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811133
Recruitment Status : Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : March 30, 2020
Sponsor:
Collaborators:
The Fine Foundation
Jarrow Formulas Inc
Information provided by (Responsible Party):
Ronald M. Glick, MD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Anxiety Disorders Anxiety Drug: Inositol Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arm Intervention/treatment
Experimental: Inositol
Subjects will receive inositol
Drug: Inositol
Subjects will receive inositol
Other Name: Myoinositol




Primary Outcome Measures :
  1. To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S). [ Time Frame: 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.

  2. To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using the Patient Global Index of Change Severity (PGIC-S). [ Time Frame: 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.

  3. 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. [ Time Frame: Weeks 1-14 ]
    At study completion, the number of participants who remained on myo-inositol for the full 10-12 weeks will be counted.

  4. 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. [ Time Frame: 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.

  5. 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. [ Time Frame: 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.

  6. To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit. [ Time Frame: 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.

  7. 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. [ Time Frame: Week 1 & Week 10-12 ]
    A glucometer will be used to test the blood glucose levels of participants.

  8. To measure the safety of myo-inositol, physical measurements (height and weight) will be obtained. [ Time Frame: 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.


Secondary Outcome Measures :
  1. To measure the effectiveness of myo-inositol for mood symptoms, a change from baseline on the Moods and Feelings Questionnaire (MFQ) will be evaluated. [ Time Frame: Weeks 1-12 ]
    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.

  2. To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Improvement (CGI-I) will be evaluated. [ Time Frame: Weeks 2-12 ]
    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.

  3. To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Severity (CGI-S) will be evaluated. [ Time Frame: Weeks 2-12 ]
    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.

  4. 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. [ Time Frame: Week 1 & Weeks 10-12 ]
    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.

  5. 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. [ Time Frame: Weeks 2-12 ]
    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".

  6. 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. [ Time Frame: Weeks 1-12 ]
    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.

  7. 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. [ Time Frame: Weeks 1-12 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. At least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the Pediatric Anxiety Rating Scale (PARS).
  4. On a stable dose of psychotropic medications for at least one month, with no major changes projected.

Exclusion Criteria:

  1. Presence of prominent diarrhea.
  2. Diagnosis of diabetes mellitus.
  3. Presence of active suicidal ideation and behavior or psychosis. B-SSRS ideation score greater than 1. B-SSRS behavior score greater than 0.
  4. Weight less than 20 kg.
  5. Known pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811133


Contacts
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Contact: Christine McFarland 412-623-6872 mcfarlandce@upmc.edu
Contact: Ronald Glick, MD 412-623-3023 glickrm@upmc.edu

Locations
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United States, Pennsylvania
Child and Adolescent Bipolar Services-WPIC Bellefield
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ronald M. Glick, MD
The Fine Foundation
Jarrow Formulas Inc
Investigators
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Principal Investigator: Ronald Glick, MD University of Pittsburgh
Publications:
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Responsible Party: Ronald M. Glick, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02811133    
Other Study ID Numbers: STUDY19100221
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request from other researchers, we will make available de-identified subject data, as appropriate.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be shared, as deemed appropriate, starting 6 months after completion of the study for a period of 5 years.
Access Criteria: Biomedical researcher involved in research activity in a related field and from an established research institution.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ronald M. Glick, MD, University of Pittsburgh:
inositol
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Bipolar Disorder
Pathologic Processes
Mental Disorders
Bipolar and Related Disorders
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs